Attendance at TreatmentSBIRT-PTSDNCT01597856
Evaluation and Treatment of Substance Abuse in Veterans With PTSD Disability Claims
A study testing SBIRT in people with Attendance at Treatment and PTSD, Substance Use, and Attendance at Treatment, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Attendance at Treatment, PTSD, Substance Use, and Attendance at Treatment
- What is being tested?
- SBIRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Mar 2013to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Will not be able to attend the week 4 or 12 appointment because of anticipated incarceration or move
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516
About this study
Official title: Evaluation and Treatment of Substance Use in Veterans With PTSD Disability Claims
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.
Read the 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.
- Being tested
- SBIRT
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBIRTBehavioural
SBIRT Therapy overview-
- Therapist explains purpose of the therapy.
- Inquiry about Compensation examination-ask if Veteran has questions about determination process and address concerns.
- Discuss relationship between PTSD and substance use- long-term substance use is a form of avoidance and barrier to recovery.
- Discuss treatment needs, administer screening, provide feedback.
| Study group | Role | What they receive |
|---|---|---|
| SBIRT | Experimental | 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. Receives: Behavioral: SBIRT |
| No additional treatment | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
Secondary outcomes (2)
Substance Use by Treatment Group Over Time
Mean days self-reported risky drug or alcohol use
Measured: 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
Mean PTSD Severity Score
Measure on Clinical Assessment of PTSD Severity (CAPS IV) rating scale (range 0-136, higher is more severe symptoms).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study start18 Mar 2013
- Primary completion30 Sep 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attendance at TreatmentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Marc I. Rosen, MD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597856
- Sponsor's protocol ID
- IIR 11-091
- Acronym
- SBIRT-PTSD
- Status last verified
- Jan 2020
- First submitted
- 10 May 2012
- Last updated
- 27 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jankowski RL, Black AC, Lazar CM, Brummett BR, Rosen MI. Consideration of substance use in compensation and pension examinations of veterans filing PTSD claims. PLoS One. 2019 Feb 6;14(2):e0210938. doi: 10.1371/journal.pone.0210938. eCollection 2019.
PubMed 30726261Black AC, Meshberg-Cohen S, Perez-Ortiz AC, Thornhill TA, Rosen MI. Veterans' compensation claims beliefs predict timing of PTSD treatment use relative to compensation and pension exam. PLoS One. 2018 Dec 27;13(12):e0209488. doi: 10.1371/journal.pone.0209488. eCollection 2018.
PubMed 30589882Meshberg-Cohen S, Kachadourian L, Black AC, Rosen MI. Relationship between substance use and attitudes towards seeking professional psychological help among veterans filing PTSD claims. Addict Behav. 2017 Nov;74:9-12. doi: 10.1016/j.addbeh.2017.05.024. Epub 2017 May 23.
PubMed 28558337
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Treatment of Substance Use in Veterans With PTSD Disability Claims
- ClinicalTrials.gov ID
- NCT01597856
- Acronym / sponsor ID
- SBIRT-PTSD / IIR 11-091
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Yale University
- Study start
- 18 Mar 2013 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 14 May 2012 (estimated)
- Results
- Posted 10 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBIRT | Experimental | Behavioral: SBIRTThe 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. |
| No additional treatment | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Will not be able to attend the week 4 or 12 appointment because of anticipated incarceration or move
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBIRTSBIRT 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. | Behavioural | SBIRT |
Primary outcome
Treatment Attendance by Treatment Group Over Time
Time frame: 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
2 secondary outcomes
Substance Use by Treatment Group Over Time
Time frame: 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
Mean PTSD Severity Score
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30726261Jankowski RL, Black AC, Lazar CM, Brummett BR, Rosen MI. Consideration of substance use in compensation and pension examinations of veterans filing PTSD claims. PLoS One. 2019 Feb 6;14(2):e0210938. doi: 10.1371/journal.pone.0210938. eCollection 2019.
- Results publication: PubMed 30589882Black AC, Meshberg-Cohen S, Perez-Ortiz AC, Thornhill TA, Rosen MI. Veterans' compensation claims beliefs predict timing of PTSD treatment use relative to compensation and pension exam. PLoS One. 2018 Dec 27;13(12):e0209488. doi: 10.1371/journal.pone.0209488. eCollection 2018.
- Results publication: PubMed 28558337Meshberg-Cohen S, Kachadourian L, Black AC, Rosen MI. Relationship between substance use and attitudes towards seeking professional psychological help among veterans filing PTSD claims. Addict Behav. 2017 Nov;74:9-12. doi: 10.1016/j.addbeh.2017.05.024. Epub 2017 May 23.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc I. Rosen, MD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBIRT in people with Attendance at Treatment and PTSD, Substance Use, and Attendance at Treatment, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Attendance by Treatment Group Over Time (time frame: 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01597856, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.