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

Primary Purpose

Stress Disorders, Post-traumatic, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer-Supported Web CBT
Self-Managed Web CBT
Sponsored by
Syracuse VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-traumatic focused on measuring peer support, web-based treatment, veterans, PTSD, Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Syracuse Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Peer-Supported Web CBT

Self-Managed Web CBT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PTSD Severity
The PTSD Checklist-Specific measures PTSD severity with 17 items rated on a 1-5 scale. Higher numbers indicate greater symptom severity.
Percentage of binge drinking days
The Timeline Follow-back measures will record daily alcohol consumption.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2015
Last Updated
April 24, 2017
Sponsor
Syracuse VA Medical Center
Collaborators
National Development and Research Institutes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02611843
Brief Title
Peer Supported Web-based CBT for OEF/OIF Veterans With PTSD and Substance Misuse
Official Title
Peer Supported Web-based CBT for OEF/OIF Veterans With PTSD and Substance Misuse
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Syracuse VA Medical Center
Collaborators
National Development and Research Institutes, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-traumatic, Substance Use Disorders
Keywords
peer support, web-based treatment, veterans, PTSD, Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer-Supported Web CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-Managed Web CBT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer-Supported Web CBT
Intervention Type
Behavioral
Intervention Name(s)
Self-Managed Web CBT
Primary Outcome Measure Information:
Title
PTSD Severity
Description
The PTSD Checklist-Specific measures PTSD severity with 17 items rated on a 1-5 scale. Higher numbers indicate greater symptom severity.
Time Frame
12 weeks
Title
Percentage of binge drinking days
Description
The Timeline Follow-back measures will record daily alcohol consumption.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Possemato, Ph.D.
Organizational Affiliation
Syracuse Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syracuse Veterans Affairs Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States

12. IPD Sharing Statement

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

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