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Peer Supported Web-based CBT for OEF/OIF Veterans With PTSD and Substance Misuse

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ClinicalTrials.gov Identifier: NCT02611843
Recruitment Status : Completed
First Posted : November 23, 2015
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
National Development and Research Institutes, Inc.
Information provided by (Responsible Party):
Kyle Possemato, Syracuse VA Medical Center

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-traumatic Substance Use Disorders Behavioral: Peer-Supported Web CBT Behavioral: Self-Managed Web CBT Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Peer Supported Web-based CBT for OEF/OIF Veterans With PTSD and Substance Misuse
Actual Study Start Date : November 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

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.
Behavioral: Peer-Supported Web CBT
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.
Behavioral: Self-Managed Web CBT



Primary Outcome Measures :
  1. 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.

  2. Percentage of binge drinking days [ Time Frame: 12 weeks ]
    The Timeline Follow-back measures will record daily alcohol consumption.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. At least 18 years of age,
  2. An OEF or OIF or OND veteran (verified via CPRS),
  3. 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:

  1. Plans to move out of the area within the next three months,
  2. Enrolled in psychotherapy in the last two months focused on substance use or PTSD,
  3. Have incurred a change in dose or type of a psychiatric medication that treats PTSD or substance use in the last two months,
  4. Inability to understand or provide informed consent,
  5. Inability to use English to participate in the consent process, the computerized intervention, or the assessments,
  6. In need of alcohol detoxification as determined by a score of > 15 on the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar),
  7. Current plan or intent to harm self,
  8. Medical chart diagnosis of a current psychotic disorder, including schizophrenia or bi-polar disorder,
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611843


Locations
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United States, New York
Syracuse Veterans Affairs Medical Center
Syracuse, New York, United States, 13210
Sponsors and Collaborators
Syracuse VA Medical Center
National Development and Research Institutes, Inc.
Investigators
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Principal Investigator: Kyle Possemato, Ph.D. Syracuse Veterans Affairs Medical Center

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Responsible Party: Kyle Possemato, Associate Director for Research, Center for Integrated Healthcare, Syracuse VA Medical Center
ClinicalTrials.gov Identifier: NCT02611843     History of Changes
Other Study ID Numbers: 487
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Kyle Possemato, Syracuse VA Medical Center:
peer support
web-based treatment
veterans
PTSD
Substance Use Disorders

Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders