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

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT01338506
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 81
• Location: 1
• Arms: 2
• Duration (Months): 59
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorders; Combat Disorders; Alcohol Dependence; Drug Dependence	Behavioral: Concurrent Treatment with Prolonged Exposure (COPE)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Integrated Treatment of Operation Enduring Freedom/Operation Iraqi Freedom Veterans With Post-traumatic Stress Disorder and Substance Use Disorders
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COPE Therapy Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy 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).; Other Names: Prolonged Exposure
Active Comparator: Treatment as usual 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).; Other Names: Prolonged Exposure

Outcome Measures

Primary Outcome Measures

1. Change in Post-traumatic Stress Disorder Symptomatology [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.

2. Drinks Per Drinking Day [Following 12 weeks of therapy.]

   Number of standard drinks reported during drinking day

3. Post-traumatic Stress Disorder Symptomatology [Following 12 weeks of therapy.]

   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.

4. Clinician Administered PTSD Scale Itemized Scores [After 12 weeks of treatment]

   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

Secondary Outcome Measures

1. Number of Participants Who Report Abstinence [Following 12 weeks of therapy.]

   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.

2. Beck Depression Index [Following 12 weeks of therapy.]

   Measure of depression. A lower score would indicate less severe depression. Scores range 0-30

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29401

Sponsors and Collaborators

• Medical University of South Carolina
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Sudie E Back, Ph.D., Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Sudie E. Back, Professor, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT01338506
• Other Study ID Numbers: R01DA030143-01; HR20279
• First Posted: Apr 19, 2011
• Last Update Posted: Feb 11, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Sudie E. Back, Professor, Medical University of South Carolina: 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
• Additional relevant MeSH terms: Disease; Substance-Related Disorders; Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders

Study Results

Participant Flow

Arm/Group Title	COPE Therapy	Treatment as Usual
Arm/Group Description	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).	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).
Period Title: Overall Study
STARTED	54	27
COMPLETED	29	13
NOT COMPLETED	25	14

Baseline Characteristics

Arm/Group Title	Treatment as Usual	COPE Therapy	Total
Arm/Group Description	Relapse Prevention (RP) for substance use disorders. Included 12 sessions of RP matched for time.	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).	Total of all reporting groups
Overall Participants	27	54	81
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.9 (10.3)	39.7 (11.0)	40.4 (13.9)
Sex: Female, Male (Count of Participants)
Female	4 14.8%	4 7.4%	8 9.9%
Male	23 85.2%	50 92.6%	73 90.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3.7%	2 3.7%	3 3.7%
Not Hispanic or Latino	26 96.3%	52 96.3%	78 96.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	14 51.9%	16 29.6%	30 37%
White	12 44.4%	37 68.5%	49 60.5%
More than one race	1 3.7%	1 1.9%	2 2.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	27 100%	54 100%	81 100%

Outcome Measures

1. Primary Outcome

Title	Change in Post-traumatic Stress Disorder Symptomatology
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	COPE Therapy	Treatment as Usual
Arm/Group Description	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).	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).
Measure Participants	54	27
Clinician Administered PTSD Sore	-51.2	-35.9
The PTSD Checklist for DSM-5 PTSD Diagnosis	-22.3	-10.9

2. Primary Outcome

Title	Drinks Per Drinking Day
Description	Number of standard drinks reported during drinking day
Time Frame	Following 12 weeks of therapy.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	COPE Therapy	Treatment as Usual
Arm/Group Description	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).	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).
Measure Participants	54	27
Mean (Standard Deviation) [Number of drinks per drinking day]	4.6 (3.6)	5.0 (4.1)

3. Primary Outcome

Title	Post-traumatic Stress Disorder Symptomatology
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	COPE Therapy	Treatment as Usual
Arm/Group Description	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).	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).
Measure Participants	54	27
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)

4. Primary Outcome

Title	Clinician Administered PTSD Scale Itemized Scores
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	COPE Therapy	Treatment as Usual
Arm/Group Description	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).	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).
Measure Participants	54	27
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)

5. Secondary Outcome

Title	Number of Participants Who Report Abstinence
Description	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.

Outcome Measure Data

Analysis Population Description

Reported rate of abstinence

Arm/Group Title	Treatment as Usual	COPE Therapy
Arm/Group Description	Relapse Prevention (RP) for substance use disorders. Included 12 sessions of RP matched for time.	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).
Measure Participants	27	54
Count of Participants [Participants]	7 25.9%	22 40.7%

6. Secondary Outcome

Title	Beck Depression Index
Description	Measure of depression. A lower score would indicate less severe depression. Scores range 0-30
Time Frame	Following 12 weeks of therapy.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	COPE Therapy	Treatment as Usual
Arm/Group Description	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).	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).
Measure Participants	54	27
Mean (Standard Deviation) [units on a scale (BDI)]	13 (11)	19.4 (12.3)

Adverse Events

Arm/Group Title	COPE Therapy		Treatment as Usual
Arm/Group Description	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).		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).
All Cause Mortality
	COPE Therapy		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/27 (0%)
Serious Adverse Events
	COPE Therapy		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/54 (1.9%)		1/27 (3.7%)
Psychiatric disorders
Attempted suicide	0/54 (0%)	0	1/27 (3.7%)	1
hospitalization	1/54 (1.9%)	1	0/27 (0%)	0
Other (Not Including Serious) Adverse Events
	COPE Therapy		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.