Trial Outcomes & Findings for Behavioral Activation for PTSD/Depression Treatment in OIF/OEF Veterans (NCT NCT00805532)
NCT ID: NCT00805532
Last Updated: 2018-11-05
Results Overview
The CAPS is a clinician-administered scale and is considered the "gold standard" for assessing the presence of PTSD. Items are ranked on Likert scales according to both frequency (0=never to 4=daily or almost every day) and intensity (0=none to 4=extreme) of symptoms, yielding an overall severity score by summing frequency and intensity ratings (range 0 to 136, with higher scores reflecting greater symptomatology). Scale scores corresponding to the 3 subcategories of PTSD symptoms (intrusive symptoms, avoidance symptoms, and hyperarousal symptoms) can be similarly obtained (scores range from 0-40, 0-56, 0-40 for the 3 subscales, respectively). Internal consistency, interrater reliability, and validity of this measure are strong and well-documented.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
Pre-treatment, post-treatment (12 weeks after 1st therapy session), and 3-month follow-up (24 weeks after first therapy session)
Results posted on
2018-11-05
Participant Flow
Participant milestones
| Measure |
Behavioral Activation (BA)
Behavioral Activation (BA)-BA is a present-focused, well-established treatment for depression that targets patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the individual and consistent with his/her long-term goals. BA has been modified to address PTSD concerns in addition to depression and to be delivered in 6-8, 60-minute sessions. It was delivered by skilled psychotherapists.
|
Treatment as Usual (TAU)
Participants randomized to Treatment as Usual (TAU) were referred for treatment within the PTSD Clinical Teams at the VAPORHCS and PSHCS. In both clinics providers are trained in Prolonged Exposure therapy (PE) and Cognitive Processing Therapy (CPT). Both clinics also offer skills-based "coping skills" treatments for PTSD and pharmacotherapy. Actual treatment received was determined collaboratively between the PTSD Clinic Care provider and veteran and could include any of these treatment options or combinations of treatments.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
39
|
|
Overall Study
COMPLETED
|
42
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Behavioral Activation (BA)
Behavioral Activation (BA)-BA is a present-focused, well-established treatment for depression that targets patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the individual and consistent with his/her long-term goals. BA has been modified to address PTSD concerns in addition to depression and to be delivered in 6-8, 60-minute sessions. It was delivered by skilled psychotherapists.
|
Treatment as Usual (TAU)
Participants randomized to Treatment as Usual (TAU) were referred for treatment within the PTSD Clinical Teams at the VAPORHCS and PSHCS. In both clinics providers are trained in Prolonged Exposure therapy (PE) and Cognitive Processing Therapy (CPT). Both clinics also offer skills-based "coping skills" treatments for PTSD and pharmacotherapy. Actual treatment received was determined collaboratively between the PTSD Clinic Care provider and veteran and could include any of these treatment options or combinations of treatments.
|
|---|---|---|
|
Overall Study
invalid data
|
0
|
1
|
Baseline Characteristics
Behavioral Activation for PTSD/Depression Treatment in OIF/OEF Veterans
Baseline characteristics by cohort
| Measure |
Behavioral Activation (BA)
n=42 Participants
|
Treatment as Usual (TAU)
n=38 Participants
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.2 years
STANDARD_DEVIATION 6.4 • n=99 Participants
|
30.0 years
STANDARD_DEVIATION 7.1 • n=107 Participants
|
30.1 years
STANDARD_DEVIATION 6.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian or Native Hawaiian or Pacific Islander
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White Not Hispanic
|
34 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White Hispanic
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=99 Participants
|
38 participants
n=107 Participants
|
80 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment, post-treatment (12 weeks after 1st therapy session), and 3-month follow-up (24 weeks after first therapy session)Population: OIF/OEF Veterans with PTSD
The CAPS is a clinician-administered scale and is considered the "gold standard" for assessing the presence of PTSD. Items are ranked on Likert scales according to both frequency (0=never to 4=daily or almost every day) and intensity (0=none to 4=extreme) of symptoms, yielding an overall severity score by summing frequency and intensity ratings (range 0 to 136, with higher scores reflecting greater symptomatology). Scale scores corresponding to the 3 subcategories of PTSD symptoms (intrusive symptoms, avoidance symptoms, and hyperarousal symptoms) can be similarly obtained (scores range from 0-40, 0-56, 0-40 for the 3 subscales, respectively). Internal consistency, interrater reliability, and validity of this measure are strong and well-documented.
Outcome measures
| Measure |
Behavioral Activation
n=42 Participants
Behavioral Activation (BA)- modified to be delivered in 6-8, 60 minute sessions in to address PTSD-related problems.
Behavioral Activation treatment: Behavioral Activation (BA) is a present-focused psychotherapy based on behavioral theory and principles of change, that aims to re-engage individuals with meaningful and pleasurable life activities by targeting and problem-solving patterns of avoidance. It is well-established as a treatment for depression and has been modified for the current study to address PTSD-related problems.
|
Treatment as Usual
n=38 Participants
Treatment As Usual for PTSD (TAU)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to TAU will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.
Treatment as Usual: Usual Care for PTSD (UC)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to Usual Care will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.
|
|---|---|---|
|
Clinician Administered PTSD Scale (CAPS-IV)
Pre Treatment
|
75.9 units on a scale
Standard Deviation 15.2
|
82.0 units on a scale
Standard Deviation 15.7
|
|
Clinician Administered PTSD Scale (CAPS-IV)
Post Treatment
|
54.4 units on a scale
Standard Deviation 23.0
|
70.1 units on a scale
Standard Deviation 25.7
|
|
Clinician Administered PTSD Scale (CAPS-IV)
3-Mo Follow-Up
|
56.25 units on a scale
Standard Deviation 25.4
|
64.6 units on a scale
Standard Deviation 28.3
|
SECONDARY outcome
Timeframe: Pre-treatment, post-treatment (12 weeks after first therapy appointment), 3-month follow-up (24 weeks after first therapy appointment)Population: OIF/OEF Veterans with PTSD
The PCL-M is a 17 item self-report scale that assesses the presence of DSM-IV PTSD symptoms. Items are rated on a 5-point Likert scale (1= not at all to 5=extremely) according to how much the symptom bothered the respondent over the past month. Scores range from 17-85 with higher scores representing greater symptom severity.
Outcome measures
| Measure |
Behavioral Activation
n=42 Participants
Behavioral Activation (BA)- modified to be delivered in 6-8, 60 minute sessions in to address PTSD-related problems.
Behavioral Activation treatment: Behavioral Activation (BA) is a present-focused psychotherapy based on behavioral theory and principles of change, that aims to re-engage individuals with meaningful and pleasurable life activities by targeting and problem-solving patterns of avoidance. It is well-established as a treatment for depression and has been modified for the current study to address PTSD-related problems.
|
Treatment as Usual
n=38 Participants
Treatment As Usual for PTSD (TAU)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to TAU will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.
Treatment as Usual: Usual Care for PTSD (UC)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to Usual Care will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.
|
|---|---|---|
|
Posttraumatic Stress Disorder Checklist-Military Version (PCL-M)
Pre-Treatment
|
59.0 units on a scale
Standard Deviation 7.7
|
59.0 units on a scale
Standard Deviation 8.1
|
|
Posttraumatic Stress Disorder Checklist-Military Version (PCL-M)
Post-Treatment
|
44.1 units on a scale
Standard Deviation 12.0
|
52.6 units on a scale
Standard Deviation 13.0
|
|
Posttraumatic Stress Disorder Checklist-Military Version (PCL-M)
3-Mo Follow-Up
|
48.0 units on a scale
Standard Deviation 13.4
|
51.4 units on a scale
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Pre-treatment, post-treatment (12 weeks after first therapy appointment), 3-month follow-up (24 weeks after first therapy appointment)Population: OIF/OEF Veterans with PTSD
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 Likert-scales from 0-3 (individual descriptions are provided for each number ranging from the absence of the symptom to the severe manifestation of the symptom). Scores can range from 0-63 with higher scores representing higher levels of depression. This widely used measure of depression is commonly included in outcome studies in order to determine treatment effects on severity of depressive symptoms and has excellent psychometric properties.
Outcome measures
| Measure |
Behavioral Activation
n=42 Participants
Behavioral Activation (BA)- modified to be delivered in 6-8, 60 minute sessions in to address PTSD-related problems.
Behavioral Activation treatment: Behavioral Activation (BA) is a present-focused psychotherapy based on behavioral theory and principles of change, that aims to re-engage individuals with meaningful and pleasurable life activities by targeting and problem-solving patterns of avoidance. It is well-established as a treatment for depression and has been modified for the current study to address PTSD-related problems.
|
Treatment as Usual
n=38 Participants
Treatment As Usual for PTSD (TAU)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to TAU will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.
Treatment as Usual: Usual Care for PTSD (UC)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to Usual Care will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.
|
|---|---|---|
|
Beck Depression Inventory-II (BDI-II)
Pre-Treatment
|
24.8 units on a scale
Standard Deviation 7.0
|
25.2 units on a scale
Standard Deviation 8.2
|
|
Beck Depression Inventory-II (BDI-II)
Post-Treatment
|
17.5 units on a scale
Standard Deviation 10.4
|
23.3 units on a scale
Standard Deviation 11.4
|
|
Beck Depression Inventory-II (BDI-II)
3-Mo Follow-Up
|
21.0 units on a scale
Standard Deviation 10.0
|
21.5 units on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Pre-treatment, post-treatment (12 weeks after first psychotherapy session), 3-month follow-up (24 weeks after first psychotherapy appointment)Population: OIF/OEF Veterans with PTSD
The Sheehan Disability Scale (SDS) (Sheehan, 2000) is a three item self-rated scale of impairment that is widely used in psychopharmacology studies (allowing comparison with these studies). The items ask the respondent to rate (on a Likert scale of 0-10, unimpaired to highly impaired) to what extent their symptoms interfere with their functioning in the areas of: work, social, and family life; a summary score can be obtained by summing the three items (range 0-30, unimpaired to highly impaired). The scale's reliability and concurrent validity have been demonstrated in individuals with anxiety disorders and depression.
Outcome measures
| Measure |
Behavioral Activation
n=42 Participants
Behavioral Activation (BA)- modified to be delivered in 6-8, 60 minute sessions in to address PTSD-related problems.
Behavioral Activation treatment: Behavioral Activation (BA) is a present-focused psychotherapy based on behavioral theory and principles of change, that aims to re-engage individuals with meaningful and pleasurable life activities by targeting and problem-solving patterns of avoidance. It is well-established as a treatment for depression and has been modified for the current study to address PTSD-related problems.
|
Treatment as Usual
n=38 Participants
Treatment As Usual for PTSD (TAU)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to TAU will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.
Treatment as Usual: Usual Care for PTSD (UC)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to Usual Care will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.
|
|---|---|---|
|
Sheehan Disability Scale (SDS)
Pre-Treatment
|
19.0 units on a scale
Standard Deviation 6.0
|
18.0 units on a scale
Standard Deviation 5.1
|
|
Sheehan Disability Scale (SDS)
Post-Treatment
|
15.0 units on a scale
Standard Deviation 6.7
|
16.0 units on a scale
Standard Deviation 8.9
|
|
Sheehan Disability Scale (SDS)
3-Mo Follow-Up
|
15.9 units on a scale
Standard Deviation 7.6
|
16.1 units on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Pre-treatment, post-treatment (12 weeks after 1st therapy appointment), 3-month follow-up (24 weeks after first therapy appointment)Population: OIF/OEF Veterans with PTSD
The BAS is a 25-item self-report measure that assesses overall degree of behavioral activation as well as indicators of inactivation across three subscales: avoidance/rumination, work/school impairment, and social impairment. Items are rated on 7-point Likert scales (0=not at all to 6=completely). The total BAS score reflects overall level of activation with high scores reflecting higher activation (range 0 - 150).
Outcome measures
| Measure |
Behavioral Activation
n=42 Participants
Behavioral Activation (BA)- modified to be delivered in 6-8, 60 minute sessions in to address PTSD-related problems.
Behavioral Activation treatment: Behavioral Activation (BA) is a present-focused psychotherapy based on behavioral theory and principles of change, that aims to re-engage individuals with meaningful and pleasurable life activities by targeting and problem-solving patterns of avoidance. It is well-established as a treatment for depression and has been modified for the current study to address PTSD-related problems.
|
Treatment as Usual
n=38 Participants
Treatment As Usual for PTSD (TAU)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to TAU will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.
Treatment as Usual: Usual Care for PTSD (UC)-that is provided in the VA PTSD Specialty clinics. Actual clinical practice varies between sites and between providers within sites, as is typical of the VA health care system. Subjects assigned to Usual Care will be permitted to receive medical intervention (i.e., pharmacotherapy) and any additional psychotherapy deemed appropriate by the provider. They will also be offered a minimum of 6 sessions of individual therapy.
|
|---|---|---|
|
Behavioral Activation Scale (BAS)
Pre-Treatment
|
76.0 units on a scale
Standard Deviation 19.8
|
74.2 units on a scale
Standard Deviation 17.7
|
|
Behavioral Activation Scale (BAS)
Post-Treatment
|
89.5 units on a scale
Standard Deviation 24.4
|
82.0 units on a scale
Standard Deviation 27.9
|
|
Behavioral Activation Scale (BAS)
3-Mo Follow-Up
|
79.4 units on a scale
Standard Deviation 22.4
|
83.8 units on a scale
Standard Deviation 27.8
|
Adverse Events
Behavioral Activation (BA)
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment as Usual (TAU)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Behavioral Activation (BA)
n=42 participants at risk
Behavioral Activation (BA)-BA is a present-focused, well-established treatment for depression that targets patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the individual and consistent with his/her long-term goals. BA has been modified to address PTSD concerns in addition to depression and to be delivered in 6-8, 60-minute sessions. It was delivered by skilled psychotherapists.
|
Treatment as Usual (TAU)
n=38 participants at risk
Participants randomized to Treatment as Usual (TAU) were referred for treatment within the PTSD Clinical Teams at the VAPORHCS and PSHCS. In both clinics providers are trained in Prolonged Exposure therapy (PE) and Cognitive Processing Therapy (CPT). Both clinics also offer skills-based "coping skills" treatments for PTSD and pharmacotherapy. Actual treatment received was determined collaboratively between the PTSD Clinic Care provider and veteran and could include any of these treatment options or combinations of treatments.
|
|---|---|---|
|
Psychiatric disorders
suicidal ideation with hospitalization
|
4.8%
2/42 • Number of events 2 • 24 weeks
|
5.3%
2/38 • Number of events 2 • 24 weeks
|
|
Psychiatric disorders
Suicidal ideation with no hospitalization
|
4.8%
2/42 • Number of events 2 • 24 weeks
|
5.3%
2/38 • Number of events 2 • 24 weeks
|
|
Psychiatric disorders
psychotic symptoms
|
2.4%
1/42 • Number of events 1 • 24 weeks
|
0.00%
0/38 • 24 weeks
|
|
Psychiatric disorders
discharging firearm
|
0.00%
0/42 • 24 weeks
|
2.6%
1/38 • Number of events 1 • 24 weeks
|
|
Psychiatric disorders
aggression with ER visit
|
2.4%
1/42 • Number of events 1 • 24 weeks
|
0.00%
0/38 • 24 weeks
|
|
Psychiatric disorders
homicidal ideation with crisis line call
|
0.00%
0/42 • 24 weeks
|
2.6%
1/38 • Number of events 1 • 24 weeks
|
Other adverse events
| Measure |
Behavioral Activation (BA)
n=42 participants at risk
Behavioral Activation (BA)-BA is a present-focused, well-established treatment for depression that targets patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the individual and consistent with his/her long-term goals. BA has been modified to address PTSD concerns in addition to depression and to be delivered in 6-8, 60-minute sessions. It was delivered by skilled psychotherapists.
|
Treatment as Usual (TAU)
n=38 participants at risk
Participants randomized to Treatment as Usual (TAU) were referred for treatment within the PTSD Clinical Teams at the VAPORHCS and PSHCS. In both clinics providers are trained in Prolonged Exposure therapy (PE) and Cognitive Processing Therapy (CPT). Both clinics also offer skills-based "coping skills" treatments for PTSD and pharmacotherapy. Actual treatment received was determined collaboratively between the PTSD Clinic Care provider and veteran and could include any of these treatment options or combinations of treatments.
|
|---|---|---|
|
Psychiatric disorders
very brief suicidal ideation, no hospitalization
|
4.8%
2/42 • Number of events 2 • 24 weeks
|
0.00%
0/38 • 24 weeks
|
|
Reproductive system and breast disorders
polymenorhea with hospitalization
|
2.4%
1/42 • Number of events 1 • 24 weeks
|
0.00%
0/38 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place