Trial Outcomes & Findings for Evaluation and Treatment of Substance Abuse in Veterans With PTSD Disability Claims (NCT NCT01597856)
NCT ID: NCT01597856
Last Updated: 2020-01-27
Results Overview
Mean number of weeks of substance abuse and/or mental health treatment attended (as measured by the Electronic Medical Record) by treatment group over time
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
346 participants
Primary outcome timeframe
4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
Results posted on
2020-01-27
Participant Flow
Post 9-11 era Veterans with an initial PTSD Compensation \& Pension Application scheduled were recruited from VA Connecticut Healthcare System and TN Valley Healthcare system between April 2013 and July 2016.
All enrolled Veterans completed study assessments at baseline, week 4 and week 12. Only Veterans with self-reported risky alcohol use or use of an illicit drug within the last 28 days were randomized to receive SBIRT counseling or No additional counseling conditions.
Participant milestones
| Measure |
SBIRT
The SBIRT-VA manual codifies basic substance abuse screening, treatment, Motivational Interviewing and referral procedures. It is designed for providers with minimal substance abuse expertise and is easy for experienced substance abuse providers to deliver.
Study sessions include identifying the Veterans' values through a card sort, the change ruler, on which the Veteran rates his/her willingness to change current behavior, listing the pros and cons of changing.
SBIRT: SBIRT Therapy overview-
1. Therapist explains purpose of the therapy.
2. Inquiry about Compensation examination-ask if Veteran has questions about determination process and address concerns.
3. Discuss relationship between PTSD and substance use- long-term substance use is a form of avoidance and barrier to recovery.
4. Discuss treatment needs, administer screening, provide feedback.
|
No Additional Treatment
Veterans assigned to the control condition will not receive any study-related therapy. A Veteran who completes a Compensation examination ordinarily has no further treatment, referral, or debriefing as part of the Compensation examination.
|
Not Randomized
Enrolled Veterans with no risky substance use.
|
|---|---|---|---|
|
Overall Study
STARTED
|
85
|
87
|
174
|
|
Overall Study
Week 4 Follow-up
|
62
|
67
|
129
|
|
Overall Study
COMPLETED
|
63
|
61
|
120
|
|
Overall Study
NOT COMPLETED
|
22
|
26
|
54
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation and Treatment of Substance Abuse in Veterans With PTSD Disability Claims
Baseline characteristics by cohort
| Measure |
SBIRT
n=85 Participants
The SBIRT-VA manual codifies basic substance abuse screening, treatment, Motivational Interviewing and referral procedures. It is designed for providers with minimal substance abuse expertise and is easy for experienced substance abuse providers to deliver.
Study sessions include identifying the Veterans' values through a card sort, the change ruler, on which the Veteran rates his/her willingness to change current behavior, listing the pros and cons of changing.
SBIRT: SBIRT Therapy overview-
1. Therapist explains purpose of the therapy.
2. Inquiry about Compensation examination-ask if Veteran has questions about determination process and address concerns.
3. Discuss relationship between PTSD and substance use- long-term substance use is a form of avoidance and barrier to recovery.
4. Discuss treatment needs, administer screening, provide feedback.
|
No Additional Treatment
n=87 Participants
Veterans assigned to the control condition will not receive any study-related therapy. A Veteran who completes a Compensation examination ordinarily has no further treatment, referral, or debriefing as part of the Compensation examination.
|
Not Randomized
n=174 Participants
Veterans enrolled who did not report risky substance use at baseline.
|
Total
n=346 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.9 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
36.6 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black (not Hispanic)
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White (not Hispanic)
|
55 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
227 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
85 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
346 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeks pre-baseline through week 12 post baseline, total of 16 WeeksMean number of weeks of substance abuse and/or mental health treatment attended (as measured by the Electronic Medical Record) by treatment group over time
Outcome measures
| Measure |
SBIRT
n=85 Participants
Intervention Group
|
No Additional Treatment
n=87 Participants
Control Group (Randomized, no intervention)
|
Not Randomized
n=174 Participants
Comparison Group (no risky substance use at baseline)
|
|---|---|---|---|
|
Treatment Attendance by Treatment Group Over Time
4 weeks Pre-Baseline
|
0.75 weeks
Standard Deviation 1.18
|
0.53 weeks
Standard Deviation 0.92
|
0.83 weeks
Standard Deviation 1.20
|
|
Treatment Attendance by Treatment Group Over Time
Baseline to week 4
|
0.89 weeks
Standard Deviation 1.22
|
0.55 weeks
Standard Deviation 0.81
|
0.94 weeks
Standard Deviation 1.16
|
|
Treatment Attendance by Treatment Group Over Time
Week 4 to week 12
|
1.98 weeks
Standard Deviation 2.19
|
0.98 weeks
Standard Deviation 1.50
|
1.71 weeks
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: 4 weeks pre-baseline through week 12 post baseline, total of 16 WeeksMean days self-reported risky drug or alcohol use
Outcome measures
| Measure |
SBIRT
n=85 Participants
Intervention Group
|
No Additional Treatment
n=87 Participants
Control Group (Randomized, no intervention)
|
Not Randomized
n=174 Participants
Comparison Group (no risky substance use at baseline)
|
|---|---|---|---|
|
Substance Use by Treatment Group Over Time
4 weeks Pre-Baseline
|
2.12 days
Standard Deviation 1.67
|
2.39 days
Standard Deviation 1.66
|
0.98 days
Standard Deviation 1.53
|
|
Substance Use by Treatment Group Over Time
Baseline to Week 4
|
1.73 days
Standard Deviation 1.83
|
1.63 days
Standard Deviation 1.80
|
0.98 days
Standard Deviation 1.50
|
|
Substance Use by Treatment Group Over Time
Week 4 to Week 12
|
2.60 days
Standard Deviation 3.24
|
2.77 days
Standard Deviation 3.18
|
1.80 days
Standard Deviation 2.80
|
SECONDARY outcome
Timeframe: 12 weeksMeasure on Clinical Assessment of PTSD Severity (CAPS IV) rating scale (range 0-136, higher is more severe symptoms).
Outcome measures
| Measure |
SBIRT
n=85 Participants
Intervention Group
|
No Additional Treatment
n=87 Participants
Control Group (Randomized, no intervention)
|
Not Randomized
n=174 Participants
Comparison Group (no risky substance use at baseline)
|
|---|---|---|---|
|
Mean PTSD Severity Score
Baseline
|
63.13 score on a scale
Standard Deviation 20.74
|
59.63 score on a scale
Standard Deviation 22.42
|
59.98 score on a scale
Standard Deviation 21.95
|
|
Mean PTSD Severity Score
Week 4
|
58.54 score on a scale
Standard Deviation 20.68
|
49.69 score on a scale
Standard Deviation 22.23
|
54.34 score on a scale
Standard Deviation 24.13
|
|
Mean PTSD Severity Score
Week 12
|
55.24 score on a scale
Standard Deviation 23.88
|
48.96 score on a scale
Standard Deviation 23.34
|
52.17 score on a scale
Standard Deviation 22.42
|
Adverse Events
SBIRT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Additional Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Not Randomized
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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