- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01338506
Integrated Treatment of OEF/OIF Veterans With PTSD & Substance Use Disorders (COPE)
Integrated Treatment of Operation Enduring Freedom/Operation Iraqi Freedom Veterans With Post-traumatic Stress Disorder and Substance Use Disorders
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
South Carolina
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Charleston, South Carolina, United States, 29401
- Medical University of South Carolina
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: COPE Therapy
Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use disorder.
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12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
Other Names:
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Active Comparator: Treatment as usual
CBT for substance use disorder.
|
12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Post-traumatic Stress Disorder Symptomatology
Time Frame: Following 12 weeks of therapy.
|
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.
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Drinks Per Drinking Day
Time Frame: Following 12 weeks of therapy.
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Number of standard drinks reported during drinking day
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Following 12 weeks of therapy.
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Post-traumatic Stress Disorder Symptomatology
Time Frame: Following 12 weeks of therapy.
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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.
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Clinician Administered PTSD Scale Itemized Scores
Time Frame: After 12 weeks of treatment
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Report Abstinence
Time Frame: Following 12 weeks of therapy.
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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.
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Following 12 weeks of therapy.
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Beck Depression Index
Time Frame: Following 12 weeks of therapy.
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Measure of depression.
A lower score would indicate less severe depression.
Scores range 0-30
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Following 12 weeks of therapy.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sudie E Back, Ph.D., Medical University of South Carolina
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- PTSD
- Alcohol Dependence
- Alcoholism
- Posttraumatic Stress Disorder
- Drug Abuse
- Trauma
- Military
- Psychotherapy
- Behavior Therapy
- Posttraumatic Stress
- Prolonged Exposure
- Cognitive Behavior Therapy
- Exposure therapy
- Substance Use Disorders
- Combat
- Stress Disorders
- PostTraumatic Stress Disorders
- Psychological Treatment
- Drug Dependence
- Alcohol Abuse
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA030143-01 (U.S. NIH Grant/Contract)
- HR20279 (Other Identifier: MUSC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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