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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Syracuse VA Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Development and Research Institutes, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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