- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02611843
Peer Supported Web-based CBT for OEF/OIF Veterans With PTSD and Substance Misuse
April 24, 2017 updated by: Kyle Possemato, Syracuse VA Medical Center
Veterans who served in Iraq and Afghanistan have high rates of co-morbid PTSD symptoms and hazardous substance use (HSU).
Evidence-based treatments for these problems are available in VA specialty clinics, but multiple barriers lead to low utilization of these treatments.
Novel treatment approaches are needed.
Previous research supports that 1) primary care-mental health integration (PC-MHI) services are associated with increased treatment engagement, 2) technology-based interventions are well accepted by Veterans and are more effective when delivered with professional support, and 3) Veteran peer services are associated with improved treatment engagement, patient motivation, and overall functioning.
This study will add a Peer-Support component to an existing Web-based Cognitive Behavioral Treatment (CBT) for PTSD and HSU called Moving Forward.
Preliminary data analyses from our NIAAA-funded trial indicate that participants who used Moving Forward more had larger reductions in PTSD symptoms.
Qualitative feedback supports that Veterans want interpersonal interactions while receiving treatment and need help engaging in the treatment more fully.
Therefore, this pilot study will investigate if adding peer support to Moving Forward improves patients outcomes.
A randomized controlled trial (N=30) comparing Moving Forward to Peer-Supported Moving Forward will be conducted.
The peer support component will consist of semi-structured brief sessions conducted weekly for the 12 weeks of study treatment by a VA-certified peer support specialist.
Peers will receive study-specific training and weekly supervision from clinicians that are part of the study staff.
Primary outcomes will include process outcomes (treatment engagement, patient satisfaction) and clinical outcomes (PTSD symptoms, alcohol and substance use, quality of life).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Veterans who served in Iraq and Afghanistan have high rates of co-morbid PTSD symptoms and hazardous substance use (HSU).
Evidence-based treatments for these problems are available in VA specialty clinics, but multiple barriers lead to low utilization of these treatments.
Novel treatment approaches are needed.
Previous research supports that 1) primary care-mental health integration (PC-MHI) services are associated with increased treatment engagement, 2) technology-based interventions are well accepted by Veterans and are more effective when delivered with professional support, and 3) Veteran peer services are associated with improved treatment engagement, patient motivation, and overall functioning.
This study will add a Peer-Support component to an existing Web-based Cognitive Behavioral Treatment (CBT) for PTSD and HSU called Moving Forward.
Preliminary data analyses from our NIAAA-funded trial indicate that participants who used Moving Forward more had larger reductions in PTSD symptoms.
Qualitative feedback supports that Veterans want interpersonal interactions while receiving treatment and need help engaging in the treatment more fully.
Therefore, this pilot study will investigate if adding peer support to Moving Forward improves patients outcomes.
A randomized controlled trial (N=30) comparing Moving Forward to Peer-Supported Moving Forward will be conducted.
The peer support component will consist of semi-structured brief sessions conducted weekly for the 12 weeks of study treatment by a VA-certified peer support specialist.
Peers will receive study-specific training and weekly supervision from clinicians that are part of the study staff.
Primary outcomes will include process outcomes (treatment engagement, patient satisfaction) and clinical outcomes (PTSD symptoms, alcohol and substance use, quality of life).
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13210
- Syracuse Veterans Affairs Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- At least 18 years of age,
- An OEF or OIF or OND veteran (verified via CPRS),
- Hazardous or harmful substance use as measured by one of the following: a) AUDIT score of >=7 (for women) or >= 8 (for men), b) DAST score of >=2, c) Have exited a controlled environment (e.g., detoxification unit, hospital, or correctional facility) within 30 days of screening AND within 30 days prior to entering the controlled environment report heavy drinking (>3 drinks for women or > 4 drinks for men on 1 or more days) or use of any illegal drugs or misuse of prescription drugs (use in excess of the directions or any non-medical use), 4) Determined to have diagnostic-level PTSD (1 A symptom, 1 B symptom, 3 C symptoms AND 2 D symptoms) or subthreshold PTSD (1 A symptom, 1 B symptom, 3 C symptoms OR 2 D symptoms) on the Clinician Administered PTSD Scale (CAPS),
5) Currently receiving primary medical care at the Syracuse VA Medical Center (verified via CPRS)
Exclusion Criteria:
- Plans to move out of the area within the next three months,
- Enrolled in psychotherapy in the last two months focused on substance use or PTSD,
- Have incurred a change in dose or type of a psychiatric medication that treats PTSD or substance use in the last two months,
- Inability to understand or provide informed consent,
- Inability to use English to participate in the consent process, the computerized intervention, or the assessments,
- In need of alcohol detoxification as determined by a score of > 15 on the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar),
- Current plan or intent to harm self,
- Medical chart diagnosis of a current psychotic disorder, including schizophrenia or bi-polar disorder,
- Cognitive impairment specified by a medical chart diagnosis. Diagnoses include dementia and moderate to severe traumatic brain injury (TBI). Patients with mild TBI were not excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peer-Supported Web CBT
Semi-structured brief sessions conducted weekly for the 12 weeks of study treatment by a certified peer support specialist.
Sessions focus on helping participants use the skills they are learning in the Web CBT treatment in their daily lives.
Web CBT consists of 24 brief (i.e., 20-minute) modules.
Participants will be asked to complete two modules per week.
Module topics include The Connection Between PTSD and Substance Use, Motivational Enhancement, Relaxation, Identifying, Evaluating and Challenging Automatic Thoughts, Functional Analyses of Substance Use, Substance Use Refusal Skills, Communication, Anger Management, Pain Management, and Insomnia.
|
|
Experimental: Self-Managed Web CBT
Self-managed Web CBT consists of 24 brief (i.e., 20-minute) modules.
Participants will be asked to complete two modules per week.
Module topics include The Connection Between PTSD and Substance Use, Motivational Enhancement, Relaxation, Identifying, Evaluating and Challenging Automatic Thoughts, Functional Analyses of Substance Use, Substance Use Refusal Skills, Communication, Anger Management, Pain Management, and Insomnia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Severity
Time Frame: 12 weeks
|
The PTSD Checklist-Specific measures PTSD severity with 17 items rated on a 1-5 scale.
Higher numbers indicate greater symptom severity.
|
12 weeks
|
Percentage of binge drinking days
Time Frame: 12 weeks
|
The Timeline Follow-back measures will record daily alcohol consumption.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kyle Possemato, Ph.D., Syracuse Veterans Affairs Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2015
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
November 19, 2015
First Submitted That Met QC Criteria
November 20, 2015
First Posted (Estimate)
November 23, 2015
Study Record Updates
Last Update Posted (Actual)
April 25, 2017
Last Update Submitted That Met QC Criteria
April 24, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 487
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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