Trial Outcomes & Findings for Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD (NCT NCT02391402)

NCT ID: NCT02391402

Last Updated: 2024-07-08

Results Overview

The Clinician Administered PTSD Scale (CAPS-IV; Blake et al., 1995; Weathers, Keane, \& Davidson, 2001) was used to assess initial PTSD diagnosis (DSM-IV; APA, 2000) and PTSD symptom severity across assessment time points. The CAPS is considered a "gold standard" for assessing PTSD. Items are ranked on Likert scales according to both frequency (0-4) and intensity of symptoms (0-4), yielding an overall severity score based on the sum of frequency and intensity ratings across 17 items (range 0-136) . For this study, a diagnosis of PTSD was based on a scoring rule for items to be considered present of at least a "1" on frequency and "2" on intensity, with an overall severity score of at least 45 (Weathers, Ruscio, \& Keane, 1999).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

0 weeks

Results posted on

2024-07-08

Participant Flow

Participant milestones

Participant milestones
Measure
CABA
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Overall Study
STARTED
39
34
Overall Study
COMPLETED
30
26
Overall Study
NOT COMPLETED
9
8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CABA
n=39 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=34 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Total
n=73 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
39 Participants
n=99 Participants
34 Participants
n=107 Participants
73 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Female
10 Participants
n=99 Participants
3 Participants
n=107 Participants
13 Participants
n=206 Participants
Sex: Female, Male
Male
29 Participants
n=99 Participants
31 Participants
n=107 Participants
60 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=99 Participants
3 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
White
30 Participants
n=99 Participants
24 Participants
n=107 Participants
54 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
n=99 Participants
6 Participants
n=107 Participants
12 Participants
n=206 Participants
Region of Enrollment
United States
39 Participants
n=99 Participants
34 Participants
n=107 Participants
73 Participants
n=206 Participants
Years of Education
14.58 years
STANDARD_DEVIATION 2.34 • n=99 Participants
13.73 years
STANDARD_DEVIATION 1.99 • n=107 Participants
14.19 years
STANDARD_DEVIATION 2.22 • n=206 Participants
Branch of Military Service
Army
24 Participants
n=99 Participants
18 Participants
n=107 Participants
42 Participants
n=206 Participants
Branch of Military Service
Marines
9 Participants
n=99 Participants
6 Participants
n=107 Participants
15 Participants
n=206 Participants
Branch of Military Service
Navy
4 Participants
n=99 Participants
4 Participants
n=107 Participants
8 Participants
n=206 Participants
Branch of Military Service
Air Force
2 Participants
n=99 Participants
3 Participants
n=107 Participants
5 Participants
n=206 Participants
Branch of Military Service
Coast Guard
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Branch of Military Service
Unreported
0 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants
Occupation Status
Employed
19 Participants
n=99 Participants
15 Participants
n=107 Participants
34 Participants
n=206 Participants
Occupation Status
Unemployed
20 Participants
n=99 Participants
19 Participants
n=107 Participants
39 Participants
n=206 Participants
Service Connection
Yes
4 Participants
n=99 Participants
5 Participants
n=107 Participants
9 Participants
n=206 Participants
Service Connection
No
34 Participants
n=99 Participants
26 Participants
n=107 Participants
60 Participants
n=206 Participants
Service Connection
Unreported
1 Participants
n=99 Participants
3 Participants
n=107 Participants
4 Participants
n=206 Participants
Number of Deployments
1.90 number of deployments
STANDARD_DEVIATION 1.01 • n=99 Participants
2.24 number of deployments
STANDARD_DEVIATION 1.44 • n=107 Participants
2.05 number of deployments
STANDARD_DEVIATION 1.22 • n=206 Participants

PRIMARY outcome

Timeframe: 0 weeks

Population: The total number of participants analyzed at baseline.

The Clinician Administered PTSD Scale (CAPS-IV; Blake et al., 1995; Weathers, Keane, \& Davidson, 2001) was used to assess initial PTSD diagnosis (DSM-IV; APA, 2000) and PTSD symptom severity across assessment time points. The CAPS is considered a "gold standard" for assessing PTSD. Items are ranked on Likert scales according to both frequency (0-4) and intensity of symptoms (0-4), yielding an overall severity score based on the sum of frequency and intensity ratings across 17 items (range 0-136) . For this study, a diagnosis of PTSD was based on a scoring rule for items to be considered present of at least a "1" on frequency and "2" on intensity, with an overall severity score of at least 45 (Weathers, Ruscio, \& Keane, 1999).

Outcome measures

Outcome measures
Measure
CABA
n=39 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=34 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
PTSD Symptoms From Baseline as Measured by the Clinician Administered PTSD Scale - 5
40.62 score on a scale
Standard Deviation 10.65
40.53 score on a scale
Standard Deviation 10.31

PRIMARY outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Clinician Administered PTSD Scale (CAPS-IV; Blake et al., 1995; Weathers, Keane, \& Davidson, 2001) was used to assess initial PTSD diagnosis (DSM-IV; APA, 2000) and PTSD symptom severity across assessment time points. The CAPS is considered a "gold standard" for assessing PTSD. Items are ranked on Likert scales according to both frequency (0-4) and intensity of symptoms (0-4), yielding an overall severity score based on the sum of frequency and intensity ratings across 17 items (range 0-136) . For this study, a diagnosis of PTSD was based on a scoring rule for items to be considered present of at least a "1" on frequency and "2" on intensity, with an overall severity score of at least 45 (Weathers, Ruscio, \& Keane, 1999).

Outcome measures

Outcome measures
Measure
CABA
n=25 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=23 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
PTSD Symptoms at 14 Weeks as Measured by the Clinician Administered PTSD Scale - 5
33.32 score on a scale
Standard Deviation 13.43
37.35 score on a scale
Standard Deviation 13.71

PRIMARY outcome

Timeframe: 0 weeks

Population: The total number of participants analyzed at baseline.

The Posttraumatic Stress Disorder Checklist-Fifth Edition (PCL-5; Blanchard, Jones-Alexander, Buckley, \& Forneris, 1996; Weathers, Litz, Herman, Huska, \& Keane, 1993; Weathers et al., 2013) was used to assess participants subjective PTSD related distress. The PCL-5 is a 20 item self-report measure that assesses the presence of DSM-5 PTSD symptoms. Items are rated on a 5-point Likert scale ranging from 0 to 4 according to how much the symptom bothered the respondent over the past month. Total scores with scores range from 0-80, with higher scores indicating more symptomatic distress. Scores totaling 31 or more are associated with presumptive PTSD among military populations.

Outcome measures

Outcome measures
Measure
CABA
n=39 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=34 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
PTSD Symptoms From Baseline as Measured by the PTSD Checklist-5
50.15 score on a scale
Standard Deviation 14.48
51.21 score on a scale
Standard Deviation 13.49

PRIMARY outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Posttraumatic Stress Disorder Checklist-Fifth Edition (PCL-5; Blanchard, Jones-Alexander, Buckley, \& Forneris, 1996; Weathers, Litz, Herman, Huska, \& Keane, 1993; Weathers et al., 2013) was used to assess participants subjective PTSD related distress. The PCL-5 is a 20 item self-report measure that assesses the presence of DSM-5 PTSD symptoms. Items are rated on a 5-point Likert scale ranging from 0 to 4 according to how much the symptom bothered the respondent over the past month. Total scores with scores range from 0-80, with higher scores indicating more symptomatic distress. Scores totaling 31 or more are associated with presumptive PTSD among military populations.

Outcome measures

Outcome measures
Measure
CABA
n=25 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=24 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
PTSD Symptoms at 14 Weeks as Measured by the PTSD Checklist-5
44.92 score on a scale
Standard Deviation 16.45
52.17 score on a scale
Standard Deviation 16.66

PRIMARY outcome

Timeframe: 0 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Hopkins Verbal Memory Test-Revised (HVLT-R; Brandt, 1991) is a measure of uncontextualized verbal learning and delayed recall. This score is converted to a standardized T-score (mean =50, S =10). The lower the T-score, the worse the performance.

Outcome measures

Outcome measures
Measure
CABA
n=37 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=27 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Baseline Memory as Measured by the Hopkins Verbal Memory Test - Revised
35.05 T-score
Standard Deviation 11.40
33.74 T-score
Standard Deviation 10.84

PRIMARY outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Hopkins Verbal Memory Test-Revised (HVLT-R; Brandt, 1991) is a measure of uncontextualized verbal learning and delayed recall. This score is converted to a standardized T-score (mean =50, S =10). The lower the T-score, the worse the performance.

Outcome measures

Outcome measures
Measure
CABA
n=24 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=20 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Memory at 14 Weeks as Measured by the Hopkins Verbal Memory Test - Revised
45.33 T-score
Standard Deviation 13.58
37.30 T-score
Standard Deviation 13.22

PRIMARY outcome

Timeframe: 0 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest (WAIS-IV; Wechsler, D., 2008) is a measure of attention and working memory. A higher total score indicates a higher level of performance (range 0-48). Raw scores are converted to scaled scores (e.g., 1-20), with higher scaled scores indicating a higher level of performance.

Outcome measures

Outcome measures
Measure
CABA
n=37 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=27 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Attention and Working Memory From Baseline as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest
8.95 scaled score
Standard Deviation 2.52
9.22 scaled score
Standard Deviation 2.83

PRIMARY outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest (WAIS-IV; Wechsler, D., 2008) is a measure of attention and working memory. A higher total score indicates a higher level of performance (range 0-48). Raw scores are converted to scaled scores (e.g., 1-20), with higher scaled scores indicating a higher level of performance.

Outcome measures

Outcome measures
Measure
CABA
n=24 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=20 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Attention and Working Memory at 14 Weeks as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest
10.46 scaled score
Standard Deviation 2.43
9.40 scaled score
Standard Deviation 2.87

PRIMARY outcome

Timeframe: 0 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Controlled Oral Word Association Test (COWAT; Ruff et al., 1996; Spreen, 1998) is a commonly used phonemic and semantic fluency word production test. A higher score indicates a higher level of performance (range 0-patient maximum).

Outcome measures

Outcome measures
Measure
CABA
n=37 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=26 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Verbal Fluency From Baseline as Measured by the Controlled Oral Word Association Test
43.68 raw score
Standard Deviation 8.18
43.54 raw score
Standard Deviation 11.93

PRIMARY outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Controlled Oral Word Association Test (COWAT; Ruff et al., 1996; Spreen, 1998) is a commonly used phonemic and semantic fluency word production test. A higher score indicates a higher level of performance (range 0-patient maximum).

Outcome measures

Outcome measures
Measure
CABA
n=24 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=20 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Verbal Fluency at 14 Weeks as Measured by the Controlled Oral Word Association Test
44.92 raw score
Standard Deviation 7.52
41.05 raw score
Standard Deviation 11.30

PRIMARY outcome

Timeframe: 0 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Delis-Kaplan Executive Function System, Trail Making subtest (D-KEFS; Delis, Kaplan, \& Kramer, 2001; Delis, Kramer, Kaplan, \& Holdnack, 2004) is a visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Raw scores are converted to scaled scores (e.g., 1-20). A higher score indicates a higher level of performance. This scale is measuring Trial 4.

Outcome measures

Outcome measures
Measure
CABA
n=36 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=27 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Delis-Kaplan Executive Functions Scale (DKEFS) - Trails Subtest at Baseline
9.08 scaled score
Standard Deviation 3.68
8.30 scaled score
Standard Deviation 3.58

PRIMARY outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Delis-Kaplan Executive Function System, Trail Making subtest (D-KEFS; Delis, Kaplan, \& Kramer, 2001; Delis, Kramer, Kaplan, \& Holdnack, 2004) is a visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Raw scores are converted to scaled scores (e.g., 1-20). A higher score indicates a higher level of performance. This scale is measuring Trial 4.

Outcome measures

Outcome measures
Measure
CABA
n=23 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=19 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Processing Speed at 14 Weeks as Measured by Delis-Kaplan Executive Functions Scale (DKEFS) Trails Subtest
10.61 scaled score
Standard Deviation 3.09
9.79 scaled score
Standard Deviation 2.53

SECONDARY outcome

Timeframe: 0 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Beck Depression Inventory-II (BDI-II; Beck, Steer, \& Brown, 1996) is a 21-item measure of subjective levels of depression. Items are rated on a 3-point Likert scale with higher scores reflecting greater severity of symptoms (range 0-63).

Outcome measures

Outcome measures
Measure
CABA
n=39 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=33 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Symptoms of Depression From Baseline as Measured by the Beck Depression Inventory -II
29.74 raw score
Standard Deviation 12.02
30.10 raw score
Standard Deviation 9.62

SECONDARY outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Beck Depression Inventory-II (BDI-II; Beck, Steer, \& Brown, 1996) is a 21-item measure of subjective levels of depression. Items are rated on a 3-point Likert scale with higher scores reflecting greater severity of symptoms (range 0-63).

Outcome measures

Outcome measures
Measure
CABA
n=25 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=24 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Symptoms of Depression at 14 Weeks as Measured by the Beck Depression Inventory -II
24.96 raw score
Standard Deviation 13.26
31.17 raw score
Standard Deviation 11.41

SECONDARY outcome

Timeframe: 0 weeks

Population: The total number of participants analyzed at baseline.

The Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, \& Griffin, 1985) is a brief measure of global life satisfaction or quality of life. Items are rated on a 7-point Likert scale with higher scores indicating greater satisfaction (range 5-35).

Outcome measures

Outcome measures
Measure
CABA
n=39 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=34 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Global Life Satisfaction From Baseline as Measured by the Satisfaction With Life Scale
15.38 raw score
Standard Deviation 6.37
15.41 raw score
Standard Deviation 7.72

SECONDARY outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, \& Griffin, 1985) is a brief measure of global life satisfaction or quality of life. Items are rated on a 7-point Likert scale with higher scores indicating greater satisfaction (range 5-35).

Outcome measures

Outcome measures
Measure
CABA
n=25 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=22 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Global Life Satisfaction at 14 Weeks as Measured by the Satisfaction With Life Scale
16.92 raw score
Standard Deviation 7.39
15.32 raw score
Standard Deviation 8.07

SECONDARY outcome

Timeframe: 0 weeks

Population: The total number of participants analyzed at baseline.

The Neurobehavioral Symptom Inventory (NSI; Cicerone, K.D. \& Kalmer, K., 1995) is a post-concussive symptom measure recommended for use in military studies. Items are rated on a 4-point Likert scale with higher scores reflecting greater severity of symptom disturbance since time of injury (range 0-66).

Outcome measures

Outcome measures
Measure
CABA
n=39 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=34 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Postconcussion Symptoms From Baseline as Measured by the Neurobehavioral Symptom Inventory
45.79 raw score
Standard Deviation 14.81
46.38 raw score
Standard Deviation 10.96

SECONDARY outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Neurobehavioral Symptom Inventory (NSI; Cicerone, K.D. \& Kalmer, K., 1995) is a post-concussive symptom measure recommended for use in military studies. Items are rated on a 4-point Likert scale with higher scores reflecting greater severity of symptom disturbance since time of injury (range 0-66).

Outcome measures

Outcome measures
Measure
CABA
n=25 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=23 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Postconcussion Symptoms at 14 Weeks as Measured by the Neurobehavioral Symptom Inventory
42.72 raw score
Standard Deviation 17.51
49.43 raw score
Standard Deviation 14.88

SECONDARY outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The CSQ is an 8-item questionnaire rated on a Likert scale of 1-4 used to assess client's treatment satisfaction. Scores range from 8-32, with higher scores equaling greater satisfaction.

Outcome measures

Outcome measures
Measure
CABA
n=24 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=21 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Client Satisfaction Questionnaire (CSQ)
27.75 raw score
Standard Deviation 6.07
27.24 raw score
Standard Deviation 3.29

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

Memory Compensation Questionnaire (MCQ)70. Rates the extent to which patients use various strategies to improve memory performance. 44 Items are rated on a 5-point Likert scale with higher scores indicating grater use of compensatory strategies (range 0-176).

Outcome measures

Outcome measures
Measure
CABA
n=38 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=33 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Use of Cognitive Strategies From Baseline as Measured by the Memory Compensation Questionnaire
120.18 raw score
Standard Deviation 28.67
120.97 raw score
Standard Deviation 28.46

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

Memory Compensation Questionnaire (MCQ)70. Rates the extent to which patients use various strategies to improve memory performance. 44 Items are rated on a 5-point Likert scale with higher scores indicating grater use of compensatory strategies (range 0-176).

Outcome measures

Outcome measures
Measure
CABA
n=24 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=20 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Use of Cognitive Strategies at 14 Weeks as Measured by the Memory Compensation Questionnaire
121.38 raw score
Standard Deviation 25.80
115.55 raw score
Standard Deviation 45.06

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

Rivermead Post Concussive Symptom Questionnaire (RPQ) will be used to measure postconcussive symptoms. Items are rated on a 5-point Likert scale with a higher number indicating more severe PCS (range 0-64).

Outcome measures

Outcome measures
Measure
CABA
n=38 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=33 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Postconcussion Symptoms From Baseline as Measured by the Rivermead Postconcussive Questionnaire
40.76 raw score
Standard Deviation 12.39
39.45 raw score
Standard Deviation 12.03

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

Rivermead Post Concussive Symptom Questionnaire (RPQ) will be used to measure postconcussive symptoms. Items are rated on a 5-point Likert scale with a higher number indicating more severe PCS (range 0-64).

Outcome measures

Outcome measures
Measure
CABA
n=24 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=21 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Postconcussion Symptoms at 14 Weeks as Measured by the Rivermead Postconcussive Questionnaire
35.35 raw score
Standard Deviation 15.44
37.42 raw score
Standard Deviation 15.07

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

Brief Symptom Inventory 18 (BSI 18) is a measure of anxiety symptoms. 18 items are rated on a 5-point Likert scale with higher scores indicating more severe symptoms (range 0-72).

Outcome measures

Outcome measures
Measure
CABA
n=38 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=32 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Symptoms of Anxiety From Baseline as Measured by the Brief Symptom Inventory
30.87 raw score
Standard Deviation 14.33
30.91 raw score
Standard Deviation 13.72

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

Brief Symptom Inventory 18 (BSI 18) is a measure of anxiety symptoms. 18 items are rated on a 5-point Likert scale with higher scores indicating more severe symptoms (range 0-72).

Outcome measures

Outcome measures
Measure
CABA
n=24 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=22 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Symptoms of Anxiety at 14 Weeks as Measured by the Brief Symptom Inventory
26.54 raw score
Standard Deviation 15.49
29.56 raw score
Standard Deviation 15.76

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

Neuro-QOL Satisfaction with Social Roles and Activities is a health-related quality of life assessment tool. Eight items are rated on a 5-point Likert scale. Scores were converted to T-scores (mean = 50; SD = 10). Lower T-scores indicate greater dissatisfaction.

Outcome measures

Outcome measures
Measure
CABA
n=38 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=32 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Health Related Quality of Life From Baseline as Measured by the Neuro-Quality of Life Satisfaction With Social Roles and Activities.
38.37 T-score
Standard Deviation 8.06
32.38 T-score
Standard Deviation 15.41

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

Neuro-QOL Satisfaction with Social Roles and Activities is a health-related quality of life assessment tool. Eight items are rated on a 5-point Likert scale. Scores were converted to T-scores (mean = 50; SD = 10). Lower T-scores indicate greater dissatisfaction.

Outcome measures

Outcome measures
Measure
CABA
n=24 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=22 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Health Related Quality of Life at 14 Weeks as Measured by the Neuro-Quality of Life Satisfaction With Social Roles and Activities.
37.90 T-score
Standard Deviation 12.82
38.72 T-score
Standard Deviation 4.80

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Sheehan Disability Scale is a brief self-report measure of functional impairment across three primary life domains: work/school, social life, and family life/home responsibilities. Participants rated how much their symptoms bothered or distress them over the past week on a scale from 0 (not at all) to 10 (extremely), with higher scores indicating greater functional impairment. Total scores (possible range 0-30) were used in analyses.

Outcome measures

Outcome measures
Measure
CABA
n=36 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=33 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Functional Impairment From Baseline as Measured by the Sheehan Disability Scale
20.06 raw score
Standard Deviation 7.43
21.50 raw score
Standard Deviation 6.06

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 weeks

Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.

The Sheehan Disability Scale is a brief self-report measure of functional impairment across three primary life domains: work/school, social life, and family life/home responsibilities. Participants rated how much their symptoms bothered or distress them over the past week on a scale from 0 (not at all) to 10 (extremely), with higher scores indicating greater functional impairment. Total scores (possible range 0-30) were used in analyses.

Outcome measures

Outcome measures
Measure
CABA
n=21 Participants
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=22 Participants
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Functional Impairment at 14 Weeks as Measured by the Sheehan Disability Scale
15.57 raw score
Standard Deviation 7.77
18.36 raw score
Standard Deviation 8.33

Adverse Events

CABA

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

Treatment as Usual (TAU)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
CABA
n=39 participants at risk
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=34 participants at risk
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Psychiatric disorders
Panic Attack
2.6%
1/39 • Number of events 1 • Baseline to 6-month follow up. AEs were documented at baseline, 7 weeks, 14 weeks, and 39 weeks, or in between visits if study staff were alerted to an event during treatment.
0.00%
0/34 • Baseline to 6-month follow up. AEs were documented at baseline, 7 weeks, 14 weeks, and 39 weeks, or in between visits if study staff were alerted to an event during treatment.
Psychiatric disorders
Suicidal Ideation
2.6%
1/39 • Number of events 1 • Baseline to 6-month follow up. AEs were documented at baseline, 7 weeks, 14 weeks, and 39 weeks, or in between visits if study staff were alerted to an event during treatment.
0.00%
0/34 • Baseline to 6-month follow up. AEs were documented at baseline, 7 weeks, 14 weeks, and 39 weeks, or in between visits if study staff were alerted to an event during treatment.

Other adverse events

Other adverse events
Measure
CABA
n=39 participants at risk
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
Treatment as Usual (TAU)
n=34 participants at risk
Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need.
Psychiatric disorders
Passive SI
5.1%
2/39 • Number of events 2 • Baseline to 6-month follow up. AEs were documented at baseline, 7 weeks, 14 weeks, and 39 weeks, or in between visits if study staff were alerted to an event during treatment.
0.00%
0/34 • Baseline to 6-month follow up. AEs were documented at baseline, 7 weeks, 14 weeks, and 39 weeks, or in between visits if study staff were alerted to an event during treatment.
General disorders
Emergency Department Visit
2.6%
1/39 • Number of events 2 • Baseline to 6-month follow up. AEs were documented at baseline, 7 weeks, 14 weeks, and 39 weeks, or in between visits if study staff were alerted to an event during treatment.
8.8%
3/34 • Number of events 5 • Baseline to 6-month follow up. AEs were documented at baseline, 7 weeks, 14 weeks, and 39 weeks, or in between visits if study staff were alerted to an event during treatment.

Additional Information

Megan Callahan

Portland VA

Phone: 503-220-8262

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place