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| ID | Type | Description | Link |
|---|---|---|---|
| HR20279 | Other Identifier | MUSC |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPE Therapy | Experimental | Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use disorder. |
|
| Treatment as usual | Active Comparator | CBT for substance use disorder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concurrent Treatment with Prolonged Exposure (COPE) | Behavioral | 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Drinks Per Drinking Day | Number of standard drinks reported during drinking day | 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. | Following 12 weeks of therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Beck Depression Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudie E Back, Ph.D. | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28460246 | Background | 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. | |
| 28329434 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | COPE Therapy | Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use. 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). |
| FG001 | Treatment as Usual | Current standard treatment available through the Department of Veteran's Affairs. 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment as Usual | Relapse Prevention (RP) for substance use disorders. Included 12 sessions of RP matched for time. |
| BG001 | COPE Therapy | Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants were asked their age at baseline visit using a demographic form. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Following 12 weeks of therapy. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COPE Therapy | Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use. 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Attempted suicide | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sudie Back | Medical University of South Carolina | 843-792-9383 | backs@musc.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003130 | Combat Disorders |
| D000437 | Alcoholism |
| D019966 | Substance-Related Disorders |
| D014947 | Wounds and Injuries |
| D040921 | Stress Disorders, Traumatic |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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|
| 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 |
Measure of depression. A lower score would indicate less severe depression. Scores range 0-30 |
| Following 12 weeks of therapy. |
| 28098747 | Background | 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. |
| 31010449 | Background | 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. |
| 30529244 | Result | 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. |
| 28221062 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG000 |
| COPE Therapy |
Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use disorder. 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). |
| OG001 | Treatment as Usual | CBT for substance use disorder. 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). |
|
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| Primary | Drinks Per Drinking Day | Number of standard drinks reported during drinking day | Posted | Mean | Standard Deviation | Number of drinks per drinking day | Following 12 weeks of therapy. |
|
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | Posted | Mean | Standard Deviation | score on a scale | 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. | Reported rate of abstinence | Posted | Count of Participants | Participants | Following 12 weeks of therapy. |
|
|
|
| Secondary | Beck Depression Index | Measure of depression. A lower score would indicate less severe depression. Scores range 0-30 | Posted | Mean | Standard Deviation | units on a scale (BDI) | Following 12 weeks of therapy. |
|
|
|
| 0 |
| 54 |
| 1 |
| 54 |
| 0 |
| 54 |
| EG001 | Treatment as Usual | Current standard treatment available through the Department of Veteran's Affairs. 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). | 0 | 27 | 1 | 27 | 0 | 27 |
| hospitalization | Psychiatric disorders | Systematic Assessment | Hospitalized for suicidal ideation |
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| Clinician Administered PTSD Scale - Hyperarousal |
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