Alcohol Dependence, Combat Disorders, Drug Dependence, Posttraumatic Stress Disorders
Conditions
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
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.
Interventions
BEHAVIORALConcurrent 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).
Sponsors
National Institute on Drug Abuse (NIDA)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Drinks Per Drinking Day | Following 12 weeks of therapy. | Number of standard drinks reported during drinking day |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Beck Depression Index | Following 12 weeks of therapy. | Measure of depression. A lower score would indicate less severe depression. Scores range 0-30 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment as Usual Relapse Prevention (RP) for substance use disorders.
Included 12 sessions of RP matched for time. | 27 |
| 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). | 54 |
| Total | 81 |
Baseline characteristics
| Characteristic | Treatment as Usual | Total | COPE Therapy |
|---|---|---|---|
| Age, Continuous | 41.9 years STANDARD_DEVIATION 10.3 | 40.4 years STANDARD_DEVIATION 13.9 | 39.7 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 78 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 30 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 49 Participants | 37 Participants |
| Region of Enrollment United States | 27 participants | 81 participants | 54 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 23 Participants | 73 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 27 |
| other Total, other adverse events | 0 / 54 | 0 / 27 |
| serious Total, serious adverse events | 1 / 54 | 1 / 27 |
Outcome results
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.
Time frame: Following 12 weeks of therapy.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| COPE Therapy | Change in Post-traumatic Stress Disorder Symptomatology | Clinician Administered PTSD Sore | -51.2 score on a scale |
| COPE Therapy | Change in Post-traumatic Stress Disorder Symptomatology | The PTSD Checklist for DSM-5 PTSD Diagnosis | -22.3 score on a scale |
| Treatment as Usual | Change in Post-traumatic Stress Disorder Symptomatology | Clinician Administered PTSD Sore | -35.9 score on a scale |
| Treatment as Usual | Change in Post-traumatic Stress Disorder Symptomatology | The PTSD Checklist for DSM-5 PTSD Diagnosis | -10.9 score on a scale |
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
Time frame: After 12 weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPE Therapy | Clinician Administered PTSD Scale Itemized Scores | Clinician Administered PTSD Scale- Re-experiencing | 5.6 score on a scale | Standard Deviation 7.1 |
| COPE Therapy | Clinician Administered PTSD Scale Itemized Scores | Clinician Admin PTSD Scale - Avoidance/Numbing | 10.8 score on a scale | Standard Deviation 9.7 |
| COPE Therapy | Clinician Administered PTSD Scale Itemized Scores | Clinician Administered PTSD Scale - Hyperarousal | 11.7 score on a scale | Standard Deviation 8.2 |
| Treatment as Usual | Clinician Administered PTSD Scale Itemized Scores | Clinician Administered PTSD Scale- Re-experiencing | 14.6 score on a scale | Standard Deviation 10.7 |
| Treatment as Usual | Clinician Administered PTSD Scale Itemized Scores | Clinician Admin PTSD Scale - Avoidance/Numbing | 24 score on a scale | Standard Deviation 13.4 |
| Treatment as Usual | Clinician Administered PTSD Scale Itemized Scores | Clinician Administered PTSD Scale - Hyperarousal | 19.1 score on a scale | Standard Deviation 6 |
Primary
Drinks Per Drinking Day
Number of standard drinks reported during drinking day
Time frame: Following 12 weeks of therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COPE Therapy | Drinks Per Drinking Day | 4.6 Number of drinks per drinking day | Standard Deviation 3.6 |
| Treatment as Usual | Drinks Per Drinking Day | 5.0 Number of drinks per drinking day | Standard Deviation 4.1 |
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.
Time frame: Following 12 weeks of therapy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPE Therapy | Post-traumatic Stress Disorder Symptomatology | Clinician Administered PTSD Scale (CAPS) | 27.2 score on a scale | Standard Deviation 19.4 |
| COPE Therapy | Post-traumatic Stress Disorder Symptomatology | PTSD Checklist for DSM-4 PTSD Diagnosis (PCL-5) | 37.6 score on a scale | Standard Deviation 17.2 |
| Treatment as Usual | Post-traumatic Stress Disorder Symptomatology | Clinician Administered PTSD Scale (CAPS) | 49.7 score on a scale | Standard Deviation 25.3 |
| Treatment as Usual | Post-traumatic Stress Disorder Symptomatology | PTSD Checklist for DSM-4 PTSD Diagnosis (PCL-5) | 53.1 score on a scale | Standard Deviation 14.5 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COPE Therapy | Beck Depression Index | 13 units on a scale (BDI) | Standard Deviation 11 |
| Treatment as Usual | Beck Depression Index | 19.4 units on a scale (BDI) | Standard Deviation 12.3 |
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.
Time frame: Following 12 weeks of therapy.
Population: Reported rate of abstinence
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COPE Therapy | Number of Participants Who Report Abstinence | 7 Participants |
| Treatment as Usual | Number of Participants Who Report Abstinence | 22 Participants |