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

Alcohol Dependence Clinical Trial

— COPE  

Official title:

Integrated Treatment of Operation Enduring Freedom/Operation Iraqi Freedom Veterans With Post-traumatic Stress Disorder and Substance Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338506
• Other study ID #: R01DA030143-01
• Secondary ID: HR20279
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: March 2016

Study information

• Verified date: February 2020
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Combat Disorders
• Disease
• Drug Dependence
• Posttraumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance-Related Disorders

Intervention

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).

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Back SE, Killeen T, Badour CL, Flanagan JC, Allan NP, Ana ES, Lozano B, Korte KJ, Foa EB, Brady KT. Concurrent treatment of substance use disorders and PTSD using prolonged exposure: A randomized clinical trial in military veterans. Addict Behav. 2019 Mar — View Citation

Badour CL, Flanagan JC, Gros DF, Killeen T, Pericot-Valverde I, Korte KJ, Allan NP, Back SE. Habituation of distress and craving during treatment as predictors of change in PTSD symptoms and substance use severity. J Consult Clin Psychol. 2017 Mar;85(3):2 — View Citation

Korte KJ, Bountress KE, Tomko RL, Killeen T, Moran-Santa Maria M, Back SE. Integrated Treatment of PTSD and Substance Use Disorders: The Mediating Role of PTSD Improvement in the Reduction of Depression. J Clin Med. 2017 Jan 13;6(1). pii: E9. doi: 10.3390/jcm6010009. — View Citation

Lancaster CL, Gros DF, Mullarkey MC, Badour CL, Killeen TK, Brady KT, Back SE. Does trauma-focused exposure therapy exacerbate symptoms among patients with comorbid PTSD and substance use disorders? Behav Cogn Psychother. 2019 Apr 23:1-16. doi: 10.1017/S1352465819000304. [Epub ahead of print] — View Citation

Mills AC, Badour CL, Korte KJ, Killeen TK, Henschel AV, Back SE. Integrated Treatment of PTSD and Substance Use Disorders: Examination of Imaginal Exposure Length. J Trauma Stress. 2017 Apr;30(2):166-172. doi: 10.1002/jts.22175. Epub 2017 Mar 22. — View Citation

Szafranski DD, Snead A, Allan NP, Gros DF, Killeen T, Flanagan J, Pericot-Valverde I, Back SE. Integrated, exposure-based treatment for PTSD and comorbid substance use disorders: Predictors of treatment dropout. Addict Behav. 2017 Oct;73:30-35. doi: 10.1016/j.addbeh.2017.04.005. Epub 2017 Apr 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Post-traumatic Stress Disorder Symptomatology	The hypothesis is that COPE will significantly exceed the treatment as usual control group in reducing Change in Post-traumatic Stress Disorder symptoms as measured by a reduction of 25 points or more in scores for the Clinician Administered Post-traumatic Stress Disorder Scale (CAPS).; A lower Clinician Administered Post-traumatic Stress Disorder Scale and Post-traumatic Stress Disorder Checklist score would indicate less severe Post-traumatic Stress Disorder/better outcomes.; A negative sign in front of a number represents a decrease in score and better/positive outcomes. A greater decrease in a score represents greater improvement in symptoms (more positive outcomes).; Clinician Administered Post-traumatic Stress Disorder Scale (CAPS): scores range 0-136 0-19: asymptomatic/few symptoms 20-39: mild PTSD/subthreshold 40-59: moderate PTSD/threshold 60-79: severe PTSD symptoms; =80: extreme PTSD symptoms; Post-traumatic Stress Disorder Checklist: score range 17-85.	Following 12 weeks of therapy.
Primary	Drinks Per Drinking Day	Number of standard drinks reported during drinking day	Following 12 weeks of therapy.
Primary	Post-traumatic Stress Disorder Symptomatology	Score of PTSD from Clinician Administered PTSD Scale (CAPS) and self-administered PTSD Checklist for DSM-5 PTSD Diagnosis (PCL-5).; Lower scores on CAPS and PCL would indicate less severe PTSD. A lower Clinician Administered Post-traumatic Stress Disorder Scale and Post-traumatic Stress Disorder Checklist score would indicate less severe Post-traumatic Stress Disorder/better outcomes.; A negative sign in front of a number represents a decrease in score and better/positive outcomes. A greater decrease in a score represents greater improvement in symptoms (more positive outcomes).; Clinician Administered Post-traumatic Stress Disorder Scale (CAPS): scores range 0-136 0-19: asymptomatic/few symptoms 20-39: mild PTSD/subthreshold 40-59: moderate PTSD/threshold 60-79: severe PTSD symptoms; =80: extreme PTSD symptoms; Post-traumatic Stress Disorder Checklist: score range 17-85.	Following 12 weeks of therapy.
Primary	Clinician Administered PTSD Scale Itemized Scores	Clinician Administered PTSD Scale Itemized Scores Within the assessment there are 20 symptoms of PTSD, each with an individual score.; A lower score would represent a better outcome (ie less severe symptom). The three itemized symptoms listed below represent hallmark traits/symptoms of PTSD.; Overall score range 0-136 Reexperiencing Symptoms range 0-40 Avoidance/Numbing range 0-56 Hyperarousal range 0-40	After 12 weeks of treatment
Secondary	Number of Participants Who Report Abstinence	The hypothesis is that 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.	Following 12 weeks of therapy.
Secondary	Beck Depression Index	Measure of depression. A lower score would indicate less severe depression. Scores range 0-30	Following 12 weeks of therapy.