An interventional study of Concurrent Treatment with Prolonged Exposure (COPE) in Posttraumatic Stress Disorders, Combat Disorders and Alcohol Dependence, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 81 is above the median of 70 across 1,897 interventional studies indexed under Stress Disorders, Post-Traumatic.
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Exclusion Criteria:
Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use disorder.
Behavioral: Concurrent Treatment with Prolonged Exposure (COPE)
CBT for substance use disorder.
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).
Also known as: Prolonged Exposure
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.
Time frame: Following 12 weeks of therapy.
Drinks Per Drinking Day
Number of standard drinks reported during drinking day
Time frame: Following 12 weeks of therapy.
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.
Time frame: Following 12 weeks of therapy.
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
Time frame: After 12 weeks of treatment
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.
Time frame: Following 12 weeks of therapy.
Beck Depression Index
Measure of depression. A lower score would indicate less severe depression. Scores range 0-30
Time frame: Following 12 weeks of therapy.
| Milestone | COPE Therapy | Treatment as Usual |
|---|---|---|
| Started | 54 | 27 |
| Completed | 29 | 13 |
| Not completed | 25 | 14 |
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.
| score on a scale | COPE Therapy | Treatment as Usual |
|---|---|---|
| Clinician Administered PTSD Sore | -51.2 (-59.7 to -42.8) | -35.9 (-48.8 to -23) |
| The PTSD Checklist for DSM-5 PTSD Diagnosis | -22.3 (-29.3 to -15.3) | -10.9 (-18 to -3.9) |
Number of standard drinks reported during drinking day
| Number of drinks per drinking day | COPE Therapy | Treatment as Usual |
|---|---|---|
| Drinks Per Drinking Day | 4.6 ± 3.6 | 5.0 ± 4.1 |
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.
| score on a scale | COPE Therapy | Treatment as Usual |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS) | 27.2 ± 19.4 | 49.7 ± 25.3 |
| PTSD Checklist for DSM-4 PTSD Diagnosis (PCL-5) | 37.6 ± 17.2 | 53.1 ± 14.5 |
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
| score on a scale | COPE Therapy | Treatment as Usual |
|---|---|---|
| Clinician Administered PTSD Scale- Re-experiencing | 5.6 ± 7.1 | 14.6 ± 10.7 |
| Clinician Admin PTSD Scale - Avoidance/Numbing | 10.8 ± 9.7 | 24 ± 13.4 |
| Clinician Administered PTSD Scale - Hyperarousal | 11.7 ± 8.2 | 19.1 ± 6.0 |
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.
| Participants | Treatment as Usual | COPE Therapy |
|---|---|---|
| Number of Participants Who Report Abstinence | 7 | 22 |
Measure of depression. A lower score would indicate less severe depression. Scores range 0-30
| units on a scale (BDI) | COPE Therapy | Treatment as Usual |
|---|---|---|
| Beck Depression Index | 13 ± 11 | 19.4 ± 12.3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| COPE Therapy | 0/54 (0%) | 1/54 (1.9%) | 0/54 (0%) |
| Treatment as Usual | 0/27 (0%) | 1/27 (3.7%) | 0/27 (0%) |
| Event | COPE Therapy | Treatment as Usual |
|---|---|---|
| Attempted suicidePsychiatric disorders | 0/54 | 1/27 |
| hospitalizationPsychiatric disorders | 1/54 | 0/27 |
| Age, Continuous(years) | Treatment as Usual | COPE Therapy | Total |
|---|---|---|---|
| Mean | 41.9 ± 10.3 | 39.7 ± 11.0 | 40.4 ± 13.9 |
| Sex: Female, Male(Participants) | Treatment as Usual | COPE Therapy | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 23 | 50 | 73 |
| Ethnicity (NIH/OMB)(Participants) | Treatment as Usual | COPE Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 26 | 52 | 78 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment as Usual | COPE Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 14 | 16 | 30 |
| White | 12 | 37 | 49 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment as Usual | COPE Therapy | Total |
|---|---|---|---|
| United States | 27 | 54 | 81 |
Plan to share: No
The record gives a start of Apr 2011, a primary completion of Mar 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2020, 3 years 11 months after primary completion.
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Stress Disorders, Post-Traumatic →
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