Trial Outcomes & Findings for Brief Anxiety Skills Training Intervention for Veterans in Primary Care (NCT NCT04829240)
NCT ID: NCT04829240
Last Updated: 2026-08-07
Results Overview
Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and Impairment Scale (OASIS), which measures symptom severity and functional impairment across anxiety disorders and subthreshold symptoms. The 5-item scale demonstrates reliability (alpha = .84 in primary care sample) and validity in primary care patients. Participants indicate the frequency and intensity of anxiety, level of avoidance, and interference with activities and social functioning on a Likert scale from 0 to 4. Total scores range from 0 to 20, with higher scores indicating more severity and impairment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
213 participants
Primary outcome timeframe
Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)
Results posted on
2026-08-07
Participant Flow
Patient participants were recruited from primary care clinics at the VA Syracuse Healthcare System or VA Western New York Healthcare System at Buffalo from August 2021 through November 2024. Prospective patient participants were identified through case finding from electronic medical records and direct referrals from primary care or behavioral health providers or other studies. Provider participants were recruited via email invitations and Primary Care Mental Health Integration staff meetings.
A telephone screening identified patients eligible based on study eligibility criteria. 8 patient participants who enrolled were not randomized: after consenting, 3 withdrew without completing the baseline, 4 completed part of the baseline but were lost to contact, 1 was determined to be ineligible after baseline. (Providers were also enrolled in this hybrid trial to deliver treatment to the patient participants in both conditions, but did not contribute to Outcome Measures or Adverse Events.)
Participant milestones
| Measure |
Intervention Condition
Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans
Veterans Anxiety Skills Training Intervention: Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms
|
Control Condition
Usual care anxiety treatment
PCMHI Usual Care: Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care
|
|---|---|---|
|
Patients
STARTED
|
86
|
83
|
|
Patients
Completed 4-week Interim Assessment
|
85
|
80
|
|
Patients
Completed 8-week Interim Assessment
|
82
|
75
|
|
Patients
Completed 12-week Interim Assessment
|
79
|
72
|
|
Patients
Completed 16-week Post-treatment Assessment
|
77
|
71
|
|
Patients
COMPLETED
|
74
|
67
|
|
Patients
NOT COMPLETED
|
12
|
16
|
|
Providers
STARTED
|
17
|
19
|
|
Providers
COMPLETED
|
16
|
16
|
|
Providers
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Intervention Condition
Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans
Veterans Anxiety Skills Training Intervention: Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms
|
Control Condition
Usual care anxiety treatment
PCMHI Usual Care: Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care
|
|---|---|---|
|
Patients
Lost to Follow-up
|
8
|
11
|
|
Patients
Withdrawal by Subject
|
4
|
4
|
|
Patients
Death
|
0
|
1
|
|
Providers
Withdrawal by Subject
|
1
|
1
|
|
Providers
Logistical barriers impeded scheduling with study patient participants
|
0
|
2
|
Baseline Characteristics
Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
Baseline characteristics by cohort
| Measure |
Intervention Condition
n=102 Participants
Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans
Veterans Anxiety Skills Training Intervention: Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms
|
Control Condition
n=101 Participants
Usual care anxiety treatment
PCMHI Usual Care: Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Patients
|
52.66 years
STANDARD_DEVIATION 16.5 • n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
49.74 years
STANDARD_DEVIATION 14.3 • n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
51.23 years
STANDARD_DEVIATION 15.5 • n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Age, Continuous
Providers
|
36.5 years
STANDARD_DEVIATION 8.6 • n=17 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
36.3 years
STANDARD_DEVIATION 7.3 • n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
36.4 years
STANDARD_DEVIATION 7.8 • n=36 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Sex: Female, Male
Patients · Female
|
19 Participants
n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups. Sex is unknown for one provider participant.
|
31 Participants
n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups. Sex is unknown for one provider participant.
|
50 Participants
n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups. Sex is unknown for one provider participant.
|
|
Sex: Female, Male
Patients · Male
|
66 Participants
n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups. Sex is unknown for one provider participant.
|
51 Participants
n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups. Sex is unknown for one provider participant.
|
117 Participants
n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups. Sex is unknown for one provider participant.
|
|
Sex: Female, Male
Providers · Female
|
10 Participants
n=16 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups. Sex is unknown for one provider participant.
|
14 Participants
n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups. Sex is unknown for one provider participant.
|
24 Participants
n=35 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups. Sex is unknown for one provider participant.
|
|
Sex: Female, Male
Providers · Male
|
6 Participants
n=16 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups. Sex is unknown for one provider participant.
|
5 Participants
n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups. Sex is unknown for one provider participant.
|
11 Participants
n=35 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups. Sex is unknown for one provider participant.
|
|
Ethnicity (NIH/OMB)
Patients · Hispanic or Latino
|
8 Participants
n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
7 Participants
n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
15 Participants
n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Ethnicity (NIH/OMB)
Patients · Not Hispanic or Latino
|
77 Participants
n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
75 Participants
n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
152 Participants
n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Ethnicity (NIH/OMB)
Patients · Unknown or Not Reported
|
0 Participants
n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Ethnicity (NIH/OMB)
Providers · Hispanic or Latino
|
0 Participants
n=17 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=36 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Ethnicity (NIH/OMB)
Providers · Not Hispanic or Latino
|
17 Participants
n=17 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
19 Participants
n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
36 Participants
n=36 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Ethnicity (NIH/OMB)
Providers · Unknown or Not Reported
|
0 Participants
n=17 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=36 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Race (NIH/OMB)
Patients · American Indian or Alaska Native
|
0 Participants
n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Race (NIH/OMB)
Patients · Asian
|
2 Participants
n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
2 Participants
n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
4 Participants
n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Race (NIH/OMB)
Patients · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Race (NIH/OMB)
Patients · Black or African American
|
5 Participants
n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
5 Participants
n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
10 Participants
n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Race (NIH/OMB)
Patients · White
|
75 Participants
n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
68 Participants
n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
143 Participants
n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Race (NIH/OMB)
Patients · More than one race
|
0 Participants
n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
5 Participants
n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
5 Participants
n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Race (NIH/OMB)
Patients · Unknown or Not Reported
|
3 Participants
n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
2 Participants
n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
5 Participants
n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Race (NIH/OMB)
Providers · American Indian or Alaska Native
|
0 Participants
n=17 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=36 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Race (NIH/OMB)
Providers · Asian
|
0 Participants
n=17 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
1 Participants
n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
1 Participants
n=36 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Race (NIH/OMB)
Providers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=17 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=36 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Race (NIH/OMB)
Providers · Black or African American
|
1 Participants
n=17 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
1 Participants
n=36 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Race (NIH/OMB)
Providers · White
|
16 Participants
n=17 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
18 Participants
n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
34 Participants
n=36 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Race (NIH/OMB)
Providers · More than one race
|
0 Participants
n=17 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=36 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Race (NIH/OMB)
Providers · Unknown or Not Reported
|
0 Participants
n=17 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
0 Participants
n=36 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Region of Enrollment
United States · Patients
|
85 Participants
n=102 Participants
|
82 Participants
n=101 Participants
|
167 Participants
n=203 Participants
|
|
Region of Enrollment
United States · Providers
|
17 Participants
n=102 Participants
|
19 Participants
n=101 Participants
|
36 Participants
n=203 Participants
|
|
Site
Patients · VA Syracuse Healthcare System
|
48 Participants
n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
47 Participants
n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
95 Participants
n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Site
Patients · VA Western New York Healthcare System at Buffalo
|
37 Participants
n=85 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
35 Participants
n=82 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
72 Participants
n=167 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Site
Providers · VA Syracuse Healthcare System
|
10 Participants
n=17 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
10 Participants
n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
20 Participants
n=36 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Site
Providers · VA Western New York Healthcare System at Buffalo
|
7 Participants
n=17 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
9 Participants
n=19 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
16 Participants
n=36 Participants • Baseline demographic characteristics were assessed by Patient (n=167) and Provider (n=36) groups.
|
|
Anxiety symptom severity
|
10.75 units on a scale
STANDARD_DEVIATION 4.1 • n=85 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
10.82 units on a scale
STANDARD_DEVIATION 4.1 • n=82 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
10.78 units on a scale
STANDARD_DEVIATION 4.1 • n=167 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
|
Anxiety symptom severity level
Low (GAD-7 score <15)
|
68 Participants
n=85 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
66 Participants
n=82 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
134 Participants
n=167 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
|
Anxiety symptom severity level
High (GAD-7 score >=15)
|
17 Participants
n=85 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
16 Participants
n=82 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
33 Participants
n=167 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
|
Depression symptom severity
|
9.89 units on a scale
STANDARD_DEVIATION 4.3 • n=85 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
9.52 units on a scale
STANDARD_DEVIATION 4.5 • n=82 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
9.71 units on a scale
STANDARD_DEVIATION 4.4 • n=167 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
|
Depression symptom severity level
Low (PHQ-9 score <15)
|
73 Participants
n=85 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
71 Participants
n=82 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
144 Participants
n=167 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
|
Depression symptom severity level
High (PHQ-9 score >=15)
|
12 Participants
n=85 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
11 Participants
n=82 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
23 Participants
n=167 Participants • Only patient participants (N=167) are reflected. Provider participants did not complete clinical outcome measures, rather they provided treatment to patient participants.
|
PRIMARY outcome
Timeframe: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)Population: 167 eligible and randomized patient participants. Two randomized patient participants were discovered (after completing data collection) to have been erroneously deemed eligible for the study due to an error. As they should not have been considered eligible, their data were excluded from analysis.
Functional impairment from anxiety symptoms will be measured using the Overall Anxiety Severity and Impairment Scale (OASIS), which measures symptom severity and functional impairment across anxiety disorders and subthreshold symptoms. The 5-item scale demonstrates reliability (alpha = .84 in primary care sample) and validity in primary care patients. Participants indicate the frequency and intensity of anxiety, level of avoidance, and interference with activities and social functioning on a Likert scale from 0 to 4. Total scores range from 0 to 20, with higher scores indicating more severity and impairment.
Outcome measures
| Measure |
Intervention Condition
n=85 Participants
Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans
Veterans Anxiety Skills Training Intervention: Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms
|
Control Condition
n=82 Participants
Usual care anxiety treatment
PCMHI Usual Care: Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care
|
|---|---|---|
|
Overall Anxiety Severity and Impairment Scale Change
Baseline
|
8.72 units on a scale
Standard Error 0.42
|
9.27 units on a scale
Standard Error 0.43
|
|
Overall Anxiety Severity and Impairment Scale Change
16-week Post-treatment
|
7.10 units on a scale
Standard Error 0.44
|
7.95 units on a scale
Standard Error 0.45
|
|
Overall Anxiety Severity and Impairment Scale Change
28-week Follow-up
|
6.18 units on a scale
Standard Error 0.44
|
7.25 units on a scale
Standard Error 0.46
|
SECONDARY outcome
Timeframe: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)Population: 167 eligible and randomized patient participants. Two randomized patient participants were discovered (after completing data collection) to have been erroneously deemed eligible for the study due to an error. As they should not have been considered eligible, their data were excluded from analysis.
The secondary outcome of anxiety symptom severity will be measured with the 7-item anxiety subscale of the Depression Anxiety Stress Scale-21 (DASS-21). Participants indicate how much each items applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Subscale total scores range from 0 to 42 (raw score range of 0 to 21 is multiplied by 2), with higher scores indicating worse symptom severity. This measure has good psychometric properties in both clinical and non-clinical samples.
Outcome measures
| Measure |
Intervention Condition
n=85 Participants
Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans
Veterans Anxiety Skills Training Intervention: Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms
|
Control Condition
n=82 Participants
Usual care anxiety treatment
PCMHI Usual Care: Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care
|
|---|---|---|
|
Depression Anxiety Stress Scale-21 Change, Anxiety Subscale
Baseline
|
10.21 units on a scale
Standard Error 0.82
|
10.68 units on a scale
Standard Error 0.83
|
|
Depression Anxiety Stress Scale-21 Change, Anxiety Subscale
16-week Post-treatment
|
7.42 units on a scale
Standard Error 0.84
|
8.67 units on a scale
Standard Error 0.87
|
|
Depression Anxiety Stress Scale-21 Change, Anxiety Subscale
28-week Follow-up
|
7.67 units on a scale
Standard Error 0.85
|
8.62 units on a scale
Standard Error 0.88
|
SECONDARY outcome
Timeframe: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)Population: 167 eligible and randomized patient participants. Two randomized patient participants were discovered (after completing data collection) to have been erroneously deemed eligible for the study due to an error. As they should not have been considered eligible, their data were excluded from analysis.
The secondary outcome of depression symptom severity will be measured with the 7-item depression subscale of the Depression Anxiety Stress Scale-21 (DASS-21). Participants indicate how much each item applies to them over the past week on a scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Subscale total scores range from 0 to 42 (raw score range of 0 to 21 is multiplied by 2), with higher scores indicating worse symptom severity. This measure has good psychometric properties in both clinical and non-clinical samples.
Outcome measures
| Measure |
Intervention Condition
n=85 Participants
Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans
Veterans Anxiety Skills Training Intervention: Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms
|
Control Condition
n=82 Participants
Usual care anxiety treatment
PCMHI Usual Care: Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care
|
|---|---|---|
|
Depression Anxiety Stress Scale-21 Change, Depression Subscale
Baseline
|
12.12 units on a scale
Standard Error 0.98
|
13.66 units on a scale
Standard Error 1.00
|
|
Depression Anxiety Stress Scale-21 Change, Depression Subscale
16-week Post-treatment
|
7.94 units on a scale
Standard Error 1.00
|
10.77 units on a scale
Standard Error 1.04
|
|
Depression Anxiety Stress Scale-21 Change, Depression Subscale
28-week Follow-up
|
8.25 units on a scale
Standard Error 1.01
|
9.87 units on a scale
Standard Error 1.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)Population: 167 eligible and randomized patient participants. Two randomized patient participants were discovered (after completing data collection) to have been erroneously deemed eligible for the study due to an error. As they should not have been considered eligible, their data were excluded from analysis.
Quality of life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LESQ-SF), which measures overall enjoyment and satisfaction with various aspects of life. The 16-item scale is reliable (alpha = .86) and valid. Participants rate satisfaction with each domain on a Likert scale from 1 to 5. Total scores range from 14 to 70, with higher scores indicating greater quality of life.
Outcome measures
| Measure |
Intervention Condition
n=85 Participants
Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans
Veterans Anxiety Skills Training Intervention: Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms
|
Control Condition
n=82 Participants
Usual care anxiety treatment
PCMHI Usual Care: Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form Change
Baseline
|
46.27 units on a scale
Standard Error 1.00
|
45.91 units on a scale
Standard Error 1.02
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form Change
16-week Post-treatment
|
48.58 units on a scale
Standard Error 1.04
|
48.53 units on a scale
Standard Error 1.07
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form Change
28-week Follow-up
|
48.69 units on a scale
Standard Error 1.06
|
48.37 units on a scale
Standard Error 1.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)Population: 167 eligible and randomized patient participants. Two randomized patient participants were discovered (after completing data collection) to have been erroneously deemed eligible for the study due to an error. As they should not have been considered eligible, their data were excluded from analysis.
Overall functioning will be measured using the 3-item Sheehan Disability Scale (SDS), a self-report measure of general impairment and functional disability. The SDS comprises 11-point (0 to 10) discretized analog scales assessing how much psychiatric symptoms impair work, social, and family life. Total scores range from 0 to 30, with higher scores indicating worse impairment or functional disability. The SDS has good reliability and is sensitive to change.
Outcome measures
| Measure |
Intervention Condition
n=85 Participants
Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans
Veterans Anxiety Skills Training Intervention: Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms
|
Control Condition
n=82 Participants
Usual care anxiety treatment
PCMHI Usual Care: Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care
|
|---|---|---|
|
Sheehan Disability Scale Change
Baseline
|
11.68 units on a scale
Standard Error 0.75
|
13.15 units on a scale
Standard Error 0.76
|
|
Sheehan Disability Scale Change
16-week Post-treatment assessment
|
8.92 units on a scale
Standard Error 0.78
|
10.02 units on a scale
Standard Error 0.81
|
|
Sheehan Disability Scale Change
28-week Follow-up assessment
|
7.70 units on a scale
Standard Error 0.80
|
9.86 units on a scale
Standard Error 0.83
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)Population: 167 eligible and randomized patient participants. Two randomized patient participants were discovered (after completing data collection) to have been erroneously deemed eligible for the study due to an error. As they should not have been considered eligible, their data were excluded from analysis.
Suicidality will be assessed using the total score of the 8-item Columbia-Suicide Severity Rating Scale (CSSRS). The CSSRS has strong predictive validity and is sensitive to change. Yes responses to items were coded as 1 and summed for a total score that can range from 0 to 8, with higher scores indicating worse suicide severity.
Outcome measures
| Measure |
Intervention Condition
n=85 Participants
Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans
Veterans Anxiety Skills Training Intervention: Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms
|
Control Condition
n=82 Participants
Usual care anxiety treatment
PCMHI Usual Care: Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale, Total Score Change
Baseline
|
0.25 units on a scale
Standard Deviation 0.63
|
0.49 units on a scale
Standard Deviation 1.07
|
|
Columbia-Suicide Severity Rating Scale, Total Score Change
16-week Post-treatment assessment
|
0.15 units on a scale
Standard Deviation 0.39
|
0.44 units on a scale
Standard Deviation 1.02
|
|
Columbia-Suicide Severity Rating Scale, Total Score Change
28-week Follow-up assessment
|
0.14 units on a scale
Standard Deviation 0.35
|
0.37 units on a scale
Standard Deviation 0.92
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Post-assessment (16 weeks), Follow-up assessment (28 weeks)Population: 167 eligible and randomized patient participants. Two randomized patient participants were discovered (after completing data collection) to have been erroneously deemed eligible for the study due to an error. As they should not have been considered eligible, their data were excluded from analysis.
Suicidality will be assessed using the dichotomous suicide screen scoring used in the Veterans Health administration for the 8-item Columbia-Suicide Severity Rating Scale (CSSRS) whereby a positive screen is defined as a Yes response to items 3 (have been thinking about how you might kill yourself over the past month), 4 (had some intention of acting on thoughts of killing yourself over the past month), 5 (started to work out or worked out the details of how to kill yourself over the past month), or 8 (did anything, started to do anything, or prepared to do anything to end your life within the past 3 months). The CSSRS has strong predictive validity and is sensitive to change.
Outcome measures
| Measure |
Intervention Condition
n=85 Participants
Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans
Veterans Anxiety Skills Training Intervention: Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms
|
Control Condition
n=82 Participants
Usual care anxiety treatment
PCMHI Usual Care: Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale, Positive Screen Change
Baseline
|
2 Participants
|
6 Participants
|
|
Columbia-Suicide Severity Rating Scale, Positive Screen Change
Post-treatment (16 weeks)
|
0 Participants
|
4 Participants
|
|
Columbia-Suicide Severity Rating Scale, Positive Screen Change
Follow-up (28 weeks)
|
0 Participants
|
2 Participants
|
Adverse Events
Intervention Condition
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Control Condition
Serious events: 6 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Intervention Condition
n=86 participants at risk
Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans
Veterans Anxiety Skills Training Intervention: Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms
|
Control Condition
n=83 participants at risk
Usual care anxiety treatment
PCMHI Usual Care: Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care
|
|---|---|---|
|
Cardiac disorders
Hospitalization for medical condition
|
4.7%
4/86 • Number of events 4 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
1.2%
1/83 • Number of events 1 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Renal and urinary disorders
Hospitalization for medical condition
|
1.2%
1/86 • Number of events 1 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
2.4%
2/83 • Number of events 2 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Gastrointestinal disorders
Hospitalization for medical condition
|
2.3%
2/86 • Number of events 2 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
0.00%
0/83 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Psychiatric disorders
Psychiatric hospitalization
|
0.00%
0/86 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
2.4%
2/83 • Number of events 2 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for medical condition
|
0.00%
0/86 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
1.2%
1/83 • Number of events 1 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Ear and labyrinth disorders
Hospitalization for medical condition
|
1.2%
1/86 • Number of events 1 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
0.00%
0/83 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
Other adverse events
| Measure |
Intervention Condition
n=86 participants at risk
Modular cognitive-behavioral anxiety intervention tailored to and personalized for Veterans
Veterans Anxiety Skills Training Intervention: Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms
|
Control Condition
n=83 participants at risk
Usual care anxiety treatment
PCMHI Usual Care: Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care
|
|---|---|---|
|
Psychiatric disorders
Symptom exacerbation
|
1.2%
1/86 • Number of events 1 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
2.4%
2/83 • Number of events 2 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Eye disorders
Presented to emergency department for evaluation of medical condition
|
1.2%
1/86 • Number of events 2 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
2.4%
2/83 • Number of events 2 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Musculoskeletal and connective tissue disorders
Presented to emergency department for evaluation of medical condition
|
5.8%
5/86 • Number of events 6 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
4.8%
4/83 • Number of events 4 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Cardiac disorders
Presented to emergency department for evaluation of medical condition
|
2.3%
2/86 • Number of events 2 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
1.2%
1/83 • Number of events 1 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Ear and labyrinth disorders
Presented to emergency department for evaluation of medical condition
|
2.3%
2/86 • Number of events 3 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
2.4%
2/83 • Number of events 2 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Reproductive system and breast disorders
Presented to emergency department for evaluation of medical condition
|
1.2%
1/86 • Number of events 1 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
0.00%
0/83 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Gastrointestinal disorders
Presented to emergency department for evaluation of medical condition
|
3.5%
3/86 • Number of events 3 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
0.00%
0/83 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Respiratory, thoracic and mediastinal disorders
Presented to emergency department for evaluation of medical condition
|
5.8%
5/86 • Number of events 6 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
4.8%
4/83 • Number of events 4 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Skin and subcutaneous tissue disorders
Presented to emergency department for evaluation of medical condition
|
2.3%
2/86 • Number of events 2 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
0.00%
0/83 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Nervous system disorders
Presented to emergency department for evaluation of medical condition
|
0.00%
0/86 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
1.2%
1/83 • Number of events 1 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Endocrine disorders
Presented to emergency department for evaluation of medical condition
|
1.2%
1/86 • Number of events 1 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
0.00%
0/83 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
|
Surgical and medical procedures
Presented to emergency department for prescription
|
1.2%
1/86 • Number of events 1 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
0.00%
0/83 • Adverse event data were collected over the course of a patient participant's study participation, 28 weeks
Adverse event collection for randomized patient participants (N=169; 2 participants later determined to be ineligible are reflected) used primarily non-systematic assessment (e.g., self-report, information in medical record). Mental health symptoms were subject to systematic assessment (assessed at each study assessment and at each treatment session in intervention condition), but only one adverse event was identified this way. Adverse event data were not collected from provider participants.
|
Additional Information
Robyn L. Shepardson, PhD
VA Center for Integrated Healthcare
Phone: 315-425-4400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place