Integrated Treatment of OEF/OIF Veterans With PTSD & Substance Use Disorders (COPE)

This study is currently recruiting participants.
Verified April 2014 by Medical University of South Carolina
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sudie E. Back, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01338506
First received: April 8, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

In comparison to the general population, U.S. military and Veterans are at an increased risk for developing both substance use disorders (SUD) and Post Traumatic Stress Disorder (PTSD). Current research has shown that there is a high comorbidity of SUD and PTSD, and although there are a number of treatments for SUD and PTSD independently, there are very few effective methods to simultaneously treat both disorders. Because of this substantial gap in the treatment of both SUDs and PTSD, it has become essential to develop a combined treatment that would address and treat both disorders. Individuals, specifically U.S. military and Veterans, with SUD/PTSD have unique needs that require a specialized treatment approach. This designed approach would employ cognitive-behavioral therapy (CBT) to treat the SUD, in conjunction with Prolonged Exposure therapy to treat the PTSD. Prolonged Exposure (PE) is an empirically supported and evidence-based treatment that is currently regarded as the "gold standard" psychosocial treatment for PTSD. In combination with CBT, this treatment would address both disorders in hopes of reducing substance use and PTSD symptomatology.


Condition Intervention
Posttraumatic Stress Disorders
Combat Disorders
Alcohol Dependence
Drug Dependence
Behavioral: Concurrent Treatment with Prolonged Exposure (COPE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrated Treatment of Operation Enduring Freedom/Operation Iraqi Freedom Veterans With Post-traumatic Stress Disorder and Substance Use Disorders

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Reduction of PTSD Symptomatology [ Time Frame: Following 12 weeks of therapy. ] [ Designated as safety issue: No ]
    COPE will significantly exceed the treatment as usual control group in reducing PTSD symptoms as measured by a reduction of 25 points or more in scores for the Clinician Administered PTSD Scale (CAPS).


Secondary Outcome Measures:
  • Reduction of substance use or abstinence [ Time Frame: Following 12 weeks of therapy. ] [ Designated as safety issue: No ]
    COPE will significantly exceed the treatment as usual control group in reducing substance use as measured by decreases in percent days using and increased abstinence rates.


Estimated Enrollment: 90
Study Start Date: April 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COPE Therapy
Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.
Behavioral: Concurrent Treatment with Prolonged Exposure (COPE)
12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
Other Name: Prolonged Exposure
Active Comparator: Treatment as usual
Current standard treatment available through the Department of Veteran's Affairs.
Behavioral: Concurrent Treatment with Prolonged Exposure (COPE)
12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
Other Name: Prolonged Exposure

Detailed Description:

As a result of sustained operations in Afghanistan and Iraq, there are an increasing number of U.S. military personnel and Veterans at risk of developing both substance use disorders (SUDs) and Post Traumatic Stress Disorder (PTSD). If left untreated, individuals with SUDs and/or PTSD are at risk for other mental health problems (e.g., depression), suicidal ideation and attempts, physical health problems, reduced resiliency, lost productivity, and family/relationship impairment. While mental health services are in place for U.S. military personnel, substantial gaps in the treatment of co-occurring SUDs and PTSD exist and there is little scientific evidence available to guide the provision of care. The proposed study directly addresses this knowledge gap by testing the feasibility and preliminary efficacy of an integrative behavioral intervention for the treatment of co-occurring SUDs and PTSD modified for use among U.S. military personnel (including National Guard and Reservists) who have served in Operation Enduring Freedom and/or Operation Iraqi Freedom (OEF/OIF). The intervention, called "Concurrent Treatment with Prolonged exposure" or "COPE," represents a novel treatment that integrates cognitive-behavioral therapy for SUDs with prolonged exposure therapy for PTSD. In earlier studies with civilians, COPE has demonstrated efficacy in reducing alcohol and drug use severity, PTSD symptoms, and associated mental health problems (e.g., depression, anxiety). In this hybrid Stage Ib/Stage II study, we will (1) use a manualized, well-tolerated behavioral treatment for SUDs and PTSD (COPE); (2) employ a two-arm randomized between-groups experimental design (COPE versus a modified treatment-as usual (TAU); and (3) examine standardized, repeated dependent measures of clinical outcomes and process variables at 5 time points (pre-, mid-, and post-treatment; 3 and 6 month follow-up). The proposed project is directly responsive to the mission of the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) in that it seeks to enhance and accelerate research on the prevention and treatment of alcohol and drug use disorders (including illicit and prescription drugs) and comorbid conditions (e.g., PTSD, depression, sleep disturbances, HIV risk behaviors). The findings of this study will provide empirical evidence to inform policies and programs to better serve the needs of U.S. military personnel, Veterans, and their families.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male and female active-duty OIF/OEF military personnel and separated OIF/OEF veterans ages 18-65.
  • Diagnosis of PTSD determined by a clinician-administered study interview.

Exclusion Criteria:

  • Current bipolar disorder or other psychotic disorder (as determined by the evaluator conducting the patient interview and medical record review)
  • subjects with a current eating disorder or with dissociative identity disorder
  • currently in ongoing therapy for SUDs or PTSD, who are not willing to discontinue these therapies for the duration of the trial
  • recently prescribed maintenance anxiolytic, antidepressant, or mood stabilizing medications (must be stabilized for four weeks on meds before entry into study)
  • Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338506

Contacts
Contact: Francis Beylotte, M.S. (843) 792-2522 beylott@musc.edu
Contact: Andrew Teer, B.S. (843) 876-0736 teer@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29401
Contact: Frank M Beylotte, M.S.    843-792-2522    beylott@musc.edu   
Principal Investigator: Sudie E Back, Ph.D.         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Sudie E Back, Ph.D. Medical University of South Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: Sudie E. Back, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01338506     History of Changes
Other Study ID Numbers: R01 DA030143-01, HR20279
Study First Received: April 8, 2011
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Military
Posttraumatic Stress Disorder
PTSD
PostTraumatic Stress Disorders
Combat
Psychological Treatment
Psychotherapy
Trauma
Posttraumatic Stress
Prolonged Exposure
Exposure therapy
Behavior Therapy
Cognitive Behavior Therapy
Stress Disorders
Drug Abuse
Drug Dependence
Alcohol Abuse
Alcohol Dependence
Substance Use Disorders
Alcoholism

Additional relevant MeSH terms:
Alcoholism
Combat Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Substance-Related Disorders
Alcohol-Related Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on April 22, 2014