Attendance at Treatment, PTSD, Substance Use, and Attendance at Treatment
Conditions
Brief summary
Veterans can apply for compensation and pension (C & P) benefits for a disability related to military service. The application exam for these benefits provides an opportunity for Veterans returning from service to access VA care. The investigators will recruit Veterans applying for C & P to participate in this study. All enrolled participants will complete questionnaires around the time of their C & P exam related to substance abuse, PTSD, service use, and attitudes. The investigators will monitor enrolled Veterans' attendance at treatment over time, and examine whether C & P award, substance use, and beliefs about benefits are related to treatment attendance. Some enrolled participants will be assigned to one of two study groups: a treatment group and a no-additional-treatment group. People assigned to these groups will complete the same substance abuse, PTSD, service use, and attitudes questionnaires two additional times during the study. Participants assigned to the treatment group will receive information about the relationship between substance use and PTSD and will be referred to relevant treatment. The investigators will test whether Veterans who receive no-additional-treatment have different symptoms over time and attend less treatment sessions (mental health or substance abuse) than people assigned to treatment.
Detailed description
The Compensation examination that determines if a Veteran is entitled to any disability payments related to military service is a crucial gateway to accessing VA care for returning OEF/OIF Veterans. However, researchers and oversight agencies have noted that examiners typically do not have guidelines for evaluating comorbid conditions like substance abuse and for referring patients to treatment. In the Evaluative Component of this study, OEF/OIF Veterans presenting for Compensation evaluations for PTSD will be approached to undergo a paid battery of confidential substance use, PTSD, service use and attitude assessments prior to their scheduled Compensation examinations. The batteries will be collected again twice, four and twelve weeks after the Compensation examinations. Long-term follow-up data will be extracted from VA databases including diagnoses, the results of the Veterans' Compensation evaluations, award determination, use of VA services and attendance at mental health and/or substance abuse treatment. In the Clinical Trial Component of this study, one hundred sixty Veterans identified during the baseline evaluation as having a substance use disorder will be randomly assigned to a session of Screening, Brief Intervention and Referral to Treatment (SBIRT) or to No-Additional-Treatment. SBIRT is an approach to identifying and treating patients with substance abuse issues who are presenting for purposes other than substance abuse treatment. It involves Motivational Interviewing, which has been a consistently effective approach to facilitating engagement in substance abuse treatment in Veterans (Davis, Baer et al. 2003) and other populations. The study will examine factors associated with attendance at treatment including substance use, Veterans' beliefs about benefits, and compensation award. Group comparisons will be conducted on rates of treatment attendance, alcohol use, and PTSD symptoms.
Interventions
BEHAVIORALSBIRT
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.
Sponsors
Yale University
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Veteran of OEF or OIF, * Not currently receiving VBA Compensation for PTSD, * Able to participate psychologically and physically, able to give informed consent and complete, assessments, and participate in study procedures * Between the ages of 18-65 years old.
Exclusion criteria
* Will not be able to attend the week 4 or 12 appointment because of anticipated incarceration or move
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Attendance by Treatment Group Over Time | 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Substance Use by Treatment Group Over Time | 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks | Mean days self-reported risky drug or alcohol use |
| Mean PTSD Severity Score | 12 weeks | Measure on Clinical Assessment of PTSD Severity (CAPS IV) rating scale (range 0-136, higher is more severe symptoms). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 85 |
| 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. | 87 |
| Not Randomized Veterans enrolled who did not report risky substance use at baseline. | 174 |
| Total | 346 |
Baseline characteristics
| Characteristic | SBIRT | No Additional Treatment | Not Randomized | Total |
|---|---|---|---|---|
| Age, Continuous | 32.9 years STANDARD_DEVIATION 7.8 | 32.4 years STANDARD_DEVIATION 7.6 | 36.6 years STANDARD_DEVIATION 9.6 | 34.6 years STANDARD_DEVIATION 8.9 |
| Race/Ethnicity, Customized Asian | 2 Participants | 1 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Black (not Hispanic) | 15 Participants | 14 Participants | 32 Participants | 61 Participants |
| Race/Ethnicity, Customized Hispanic | 10 Participants | 8 Participants | 24 Participants | 42 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 4 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized White (not Hispanic) | 55 Participants | 60 Participants | 112 Participants | 227 Participants |
| Region of Enrollment United States | 85 Participants | 87 Participants | 174 Participants | 346 Participants |
| Sex: Female, Male Female | 15 Participants | 7 Participants | 24 Participants | 46 Participants |
| Sex: Female, Male Male | 70 Participants | 80 Participants | 150 Participants | 300 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 87 | 0 / 174 |
| other Total, other adverse events | 0 / 85 | 0 / 87 | 0 / 174 |
| serious Total, serious adverse events | 0 / 85 | 0 / 87 | 0 / 174 |
Outcome results
Primary
Treatment Attendance by Treatment Group Over Time
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
Time frame: 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SBIRT | Treatment Attendance by Treatment Group Over Time | Baseline to week 4 | 0.89 weeks | Standard Deviation 1.22 |
| SBIRT | Treatment Attendance by Treatment Group Over Time | 4 weeks Pre-Baseline | 0.75 weeks | Standard Deviation 1.18 |
| SBIRT | Treatment Attendance by Treatment Group Over Time | Week 4 to week 12 | 1.98 weeks | Standard Deviation 2.19 |
| No Additional Treatment | Treatment Attendance by Treatment Group Over Time | Baseline to week 4 | 0.55 weeks | Standard Deviation 0.81 |
| No Additional Treatment | Treatment Attendance by Treatment Group Over Time | 4 weeks Pre-Baseline | 0.53 weeks | Standard Deviation 0.92 |
| No Additional Treatment | Treatment Attendance by Treatment Group Over Time | Week 4 to week 12 | 0.98 weeks | Standard Deviation 1.5 |
| Not Randomized | Treatment Attendance by Treatment Group Over Time | 4 weeks Pre-Baseline | 0.83 weeks | Standard Deviation 1.2 |
| Not Randomized | Treatment Attendance by Treatment Group Over Time | Week 4 to week 12 | 1.71 weeks | Standard Deviation 2.3 |
| Not Randomized | Treatment Attendance by Treatment Group Over Time | Baseline to week 4 | 0.94 weeks | Standard Deviation 1.16 |
Secondary
Mean PTSD Severity Score
Measure on Clinical Assessment of PTSD Severity (CAPS IV) rating scale (range 0-136, higher is more severe symptoms).
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SBIRT | Mean PTSD Severity Score | Week 4 | 58.54 score on a scale | Standard Deviation 20.68 |
| SBIRT | Mean PTSD Severity Score | Baseline | 63.13 score on a scale | Standard Deviation 20.74 |
| SBIRT | Mean PTSD Severity Score | Week 12 | 55.24 score on a scale | Standard Deviation 23.88 |
| No Additional Treatment | Mean PTSD Severity Score | Week 4 | 49.69 score on a scale | Standard Deviation 22.23 |
| No Additional Treatment | Mean PTSD Severity Score | Baseline | 59.63 score on a scale | Standard Deviation 22.42 |
| No Additional Treatment | Mean PTSD Severity Score | Week 12 | 48.96 score on a scale | Standard Deviation 23.34 |
| Not Randomized | Mean PTSD Severity Score | Baseline | 59.98 score on a scale | Standard Deviation 21.95 |
| Not Randomized | Mean PTSD Severity Score | Week 12 | 52.17 score on a scale | Standard Deviation 22.42 |
| Not Randomized | Mean PTSD Severity Score | Week 4 | 54.34 score on a scale | Standard Deviation 24.13 |
Secondary
Substance Use by Treatment Group Over Time
Mean days self-reported risky drug or alcohol use
Time frame: 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SBIRT | Substance Use by Treatment Group Over Time | Baseline to Week 4 | 1.73 days | Standard Deviation 1.83 |
| SBIRT | Substance Use by Treatment Group Over Time | 4 weeks Pre-Baseline | 2.12 days | Standard Deviation 1.67 |
| SBIRT | Substance Use by Treatment Group Over Time | Week 4 to Week 12 | 2.60 days | Standard Deviation 3.24 |
| No Additional Treatment | Substance Use by Treatment Group Over Time | 4 weeks Pre-Baseline | 2.39 days | Standard Deviation 1.66 |
| No Additional Treatment | Substance Use by Treatment Group Over Time | Baseline to Week 4 | 1.63 days | Standard Deviation 1.8 |
| No Additional Treatment | Substance Use by Treatment Group Over Time | Week 4 to Week 12 | 2.77 days | Standard Deviation 3.18 |
| Not Randomized | Substance Use by Treatment Group Over Time | 4 weeks Pre-Baseline | 0.98 days | Standard Deviation 1.53 |
| Not Randomized | Substance Use by Treatment Group Over Time | Week 4 to Week 12 | 1.80 days | Standard Deviation 2.8 |
| Not Randomized | Substance Use by Treatment Group Over Time | Baseline to Week 4 | 0.98 days | Standard Deviation 1.5 |