Clinical trial NCT01338506: Integrated Treatment of OEF/OIF Veterans With PTSD & Substance Use Disorders
Official title: Integrated Treatment of Operation Enduring Freedom/Operation Iraqi Freedom Veterans With Post-traumatic Stress Disorder and Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorders
Combat Disorders
Alcohol Dependence
Drug Dependence
Keywords: 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
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-04-19
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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)

Primary outcomes:
measure: Change in Post-traumatic Stress Disorder Symptomatology
timeFrame: Following 12 weeks of therapy.
measure: Drinks Per Drinking Day
timeFrame: Following 12 weeks of therapy.
measure: Post-traumatic Stress Disorder Symptomatology
timeFrame: Following 12 weeks of therapy.
measure: Clinician Administered PTSD Scale Itemized Scores
timeFrame: After 12 weeks of treatment
Secondary outcomes:
measure: Number of Participants Who Report Abstinence
timeFrame: Following 12 weeks of therapy.
measure: Beck Depression Index
timeFrame: Following 12 weeks of therapy.
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Sudie E Back, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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):9. doi: 10.3390/jcm6010009.
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. 2020 Jan;48(1):38-53. doi: 10.1017/S1352465819000304. Epub 2019 Apr 23.
citation: 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;90:369-377. doi: 10.1016/j.addbeh.2018.11.032. Epub 2018 Nov 27.
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):274-281. doi: 10.1037/ccp0000180.