Trial Outcomes & Findings for Veteran Peer-Assisted Computerized Cognitive Behavioral Therapy for Depression (NCT NCT02057042)
NCT ID: NCT02057042
Last Updated: 2019-10-11
Results Overview
Functional status will be measured using the Veterans RAND 12-Item Health Survey (VR-12). Developed from VR-36, VR-12 includes 12 original question items from the VR-36. The questions in this survey correspond to seven different health domains inlcuding general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into a Physical Component Score (PCS) and a Mental Component Score (MCS) which allows for a comparison between the respondents physical and psychological health status.The VR-12 has somewhat greater precision at the lower end of the health status continuum than the SF-12. The VR-12 has been used in numerous prior VA focused studies. VR-12 MCS component scores are standardized to a mean of 50, with higher scores indicating better mental health and related functioning.
COMPLETED
NA
330 participants
change over time (baseline, 3 months, 6 months)
2019-10-11
Participant Flow
Participant milestones
| Measure |
Enhanced Usual Care
Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.
|
PS-cCBT
Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
167
|
|
Overall Study
COMPLETED
|
118
|
101
|
|
Overall Study
NOT COMPLETED
|
45
|
66
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Veteran Peer-Assisted Computerized Cognitive Behavioral Therapy for Depression
Baseline characteristics by cohort
| Measure |
Enhanced Usual Care
n=163 Participants
Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.
|
PS-cCBT
n=167 Participants
Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
51.6 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
134 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
265 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
119 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
31 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Education
High school or less
|
37 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Education
Some college
|
64 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Education
College graduate
|
61 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: change over time (baseline, 3 months, 6 months)Population: Numbers analyzed in each time period account for attrition in follow-up
Functional status will be measured using the Veterans RAND 12-Item Health Survey (VR-12). Developed from VR-36, VR-12 includes 12 original question items from the VR-36. The questions in this survey correspond to seven different health domains inlcuding general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into a Physical Component Score (PCS) and a Mental Component Score (MCS) which allows for a comparison between the respondents physical and psychological health status.The VR-12 has somewhat greater precision at the lower end of the health status continuum than the SF-12. The VR-12 has been used in numerous prior VA focused studies. VR-12 MCS component scores are standardized to a mean of 50, with higher scores indicating better mental health and related functioning.
Outcome measures
| Measure |
Enhanced Usual Care
n=163 Participants
Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.
|
PS-cCBT
n=167 Participants
Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues
|
|---|---|---|
|
Functional Status
Baseline
|
32.1 score on a scale
Standard Deviation 9.9
|
31.4 score on a scale
Standard Deviation 9.7
|
|
Functional Status
3 months
|
36.2 score on a scale
Standard Deviation 10.3
|
37.3 score on a scale
Standard Deviation 11.5
|
|
Functional Status
6 months
|
37.1 score on a scale
Standard Deviation 11.0
|
40.1 score on a scale
Standard Deviation 12.2
|
PRIMARY outcome
Timeframe: change over time (baseline, 3 months, 6 months)Population: Numbers analyzed in each time period account for attrition in follow-up
Inventory of Depressive Symptoms (IDS) at baseline, 3 months post intervention and 6 months post intervention. The ISD is a 16-item self-report instrument for measuring the severity of depression among individuals. Each item is rated on a four-point scale (0-3), and aggregate scores range from 0 to 27. The IDS has been widely used and shows acceptable reliability, with Cronbach's of 0.86. Severity of depression is scored according to the following ranges: 1-5 (no depression), 6-10 (mild), 11-15 (moderate), 16-20 (severe), and 21-27 (very severe).
Outcome measures
| Measure |
Enhanced Usual Care
n=163 Participants
Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.
|
PS-cCBT
n=167 Participants
Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues
|
|---|---|---|
|
Depression Symptoms
Baseline
|
13.4 score on a scale
Standard Deviation 3.6
|
14.0 score on a scale
Standard Deviation 3.9
|
|
Depression Symptoms
3 months
|
11.7 score on a scale
Standard Deviation 4.1
|
11.1 score on a scale
Standard Deviation 4.7
|
|
Depression Symptoms
6 months
|
11.2 score on a scale
Standard Deviation 4.4
|
10.6 score on a scale
Standard Deviation 5.1
|
PRIMARY outcome
Timeframe: change over time (baseline, 3 months, 6 months)Population: Numbers analyzed in each time period account for attrition in follow-up
Recovery orientation will be measured using the Recovery Assessment Scale - Short Form (RAS-SF). This 20-item scale is a shorter version of the RAS and has four factors: personal confidence and hope, willingness to ask for help, reliance on others, and no domination by symptoms. The RAS-SF shows evidence for both convergent and discriminate validity when compared to quality of life, social support, and symptomatic scales. The scale is scored by summing all items (or scale items), with 100 being the highest possible overall score. Higher scores indicate greater sense of recovery.
Outcome measures
| Measure |
Enhanced Usual Care
n=163 Participants
Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.
|
PS-cCBT
n=167 Participants
Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues
|
|---|---|---|
|
Recovery Orientation
Baseline
|
69.3 score on a scale
Standard Deviation 9.7
|
67.1 score on a scale
Standard Deviation 11.1
|
|
Recovery Orientation
3 months
|
71.7 score on a scale
Standard Deviation 10.5
|
72.6 score on a scale
Standard Deviation 13.7
|
|
Recovery Orientation
6 months
|
71.1 score on a scale
Standard Deviation 11.7
|
74.1 score on a scale
Standard Deviation 14.6
|
PRIMARY outcome
Timeframe: change over time (baseline, 3 months, 6 months)Population: Numbers analyzed in each time period account for attrition in follow-up
The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) is a valid proxy for the longer Quality of Life Enjoyment and Satisfaction (Q-LES) form and will be used to assess quality of life. It consists of 14 items that patients rate on a 5-point scale to indicate their satisfaction with a variety of life domains, including physical health, mood, work, household activities, social relationships, etc. The Q-LES-Q-SF has been shown to have high levels of reliability and has been used in numerous studies of depression, including the National Institute of Mental Health (NIMH) funded STAR\*D study. Responses are scored on a 5-point scale, where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70).
Outcome measures
| Measure |
Enhanced Usual Care
n=163 Participants
Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.
|
PS-cCBT
n=167 Participants
Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction
Baseline
|
38.8 score on a scale
Standard Deviation 8.7
|
37.7 score on a scale
Standard Deviation 8.3
|
|
Quality of Life Enjoyment and Satisfaction
3 months
|
40.5 score on a scale
Standard Deviation 9.9
|
41.6 score on a scale
Standard Deviation 9.9
|
|
Quality of Life Enjoyment and Satisfaction
6 months
|
41.0 score on a scale
Standard Deviation 10.4
|
42.5 score on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: change over time (baseline, 3 months, 6 months)Population: Numbers analyzed in each time period account for attrition in follow-up
CBT skills will be assessed using the Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ). The CBTSQ is a 16-item scale consisting of two factors, Behavioral Activation and Cognitive Restructuring. The scale shows construct validity, appears sensitive to change among patients undergoing CBT treatment, and predicts reduction in depressive symptoms. Scores are summed with a maximum score of 80. Higher scores indicate greater uptake of CBT skills.
Outcome measures
| Measure |
Enhanced Usual Care
n=163 Participants
Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.
|
PS-cCBT
n=167 Participants
Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues
|
|---|---|---|
|
Cognitive Behavioral Therapy Skills
Baseline
|
42.4 score on a scale
Standard Deviation 10.2
|
40.4 score on a scale
Standard Deviation 11.0
|
|
Cognitive Behavioral Therapy Skills
3 months
|
45.1 score on a scale
Standard Deviation 10.7
|
46.1 score on a scale
Standard Deviation 12.6
|
|
Cognitive Behavioral Therapy Skills
6 months
|
45.9 score on a scale
Standard Deviation 10.8
|
48.0 score on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: change over time (baseline, 3 months, 6 months)Population: Numbers analyzed in each time period account for attrition in follow-up
Generalized Anxiety will be measured with the Generalized Anxiety Disorder 7-item (GAD-7). Total score ranges from 0 to 21, with "cut scores" for mild, moderate and severe anxiety. Although originally developed for generalized anxiety disorder symptoms, the GAD-7 has good operating characteristics for detection and severity ratings of panic disorder and social anxiety disorder. Scores are summed with a range of 0-21. Scores represent: 0-5 mild, 6-10 moderate, 11-15 moderate/severe, and 15-21 severe anxiety.
Outcome measures
| Measure |
Enhanced Usual Care
n=163 Participants
Enhanced usual care: Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.
|
PS-cCBT
n=167 Participants
Peer-assisted computerized CBT: Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues
|
|---|---|---|
|
Anxiety
Baseline
|
11.3 score on a scale
Standard Deviation 4.7
|
11.0 score on a scale
Standard Deviation 4.3
|
|
Anxiety
3 months
|
9.5 score on a scale
Standard Deviation 4.8
|
8.8 score on a scale
Standard Deviation 5.1
|
|
Anxiety
6 months
|
9.3 score on a scale
Standard Deviation 5.1
|
8.1 score on a scale
Standard Deviation 5.2
|
Adverse Events
Enhanced Usual Care
PS-cCBT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place