Integrated Treatment for Posttraumatic Stress Disorder and Substance Abuse in Young Adults

Study Overview
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Brief Summary
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The purpose of the study is to determine the safety and efficacy of an integrated treatment for substance abuse and posttraumatic stress disorder for young adults. The integrated treatment includes two established psychosocial treatments for substance abuse (Contingency Management) and posttraumatic stress disorder (Prolonged Exposure therapy).

Official Title
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Treating Co-Occurring PTSD and Substance Abuse in High-Risk Transition Age Youth

Conditions
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Substance Use Disorder, Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Prolonged Exposure with Contingency Management
* Behavioral: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-25 years old meets diagnostic criteria for substance use disorder meets diagnostic criteria for full or subthreshold posttraumatic stress disorder currently able to provide a urine drug screen that is negative for cocaine, prescription opiates, and non-prescribed methadone or provided this type of screen in the past 60 days speaks English Exclusion Criteria: significant cognitive impairment or serious uncontrolled psychiatric problem (other than posttraumatic stress disorder) in recovery from pathological gambling or current pathological gambling diagnosis in a current domestic violence relationship

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolonged Exposure + Contingency Management<br>Standard services plus Prolonged Exposure and Contingency Management | Behavioral: Prolonged Exposure with Contingency Management<br>* Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure. Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.<br>Behavioral: Standard Care<br>* Standard care will consist of treatment as usual in a community-based substance use treatment center.<br>|
| Active Comparator: Standard Care<br>Standard substance abuse treatment services | Behavioral: Standard Care<br>* Standard care will consist of treatment as usual in a community-based substance use treatment center.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale | National Stressful Events Posttraumatic Stress Disorder Short Scale. Outcome is presented as a mean item score. Minimum value = 1, Maximum value = 5. Higher scores mean worse outcomes (more severe symptoms). | Baseline and 3-months post-baseline | 
| Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale | National Stressful Events Posttraumatic Stress Disorder Short Scale. Outcome is presented as a mean item score. Minimum value = 1, Maximum value = 5. Higher scores mean worse outcomes (more severe symptoms). | Baseline and 6-month post-baseline | 
| Longest Duration of Abstinence From Illicit Drugs (Physiological Measure - Urine Drug Screens) | Illicit drug use is assessed twice weekly during the 10 week treatment period. Longest duration of abstinence is calculated as the longest time period in weeks of consecutive negative urine drug screens for illicit drugs during the 10 weeks of treatment. | 10 week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale | Center for Epidemiological Studies-Depressed Mood. Minimum value = 0. Maximum value = 60. Higher scores mean worse outcomes (more severe symptoms). | Baseline and 3-month post-baseline | 
| Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale | Center for Epidemiological Studies-Depressed Mood. Minimum value = 0. Maximum value = 60. Higher scores mean worse outcomes (more severe symptoms). | Baseline and 6-month post-baseline | 
| Change in Quality of Life as Measured by the Quality of Life Scale | Quality of Life Scale. Minimum value = -6. Maximum value = +6. Score is an item mean. Higher scores mean better outcomes. | Baseline and 3-month post-baseline | 
| Change in Quality of Life as Measured by the Quality of Life Scale | Quality of Life Scale. Minimum value = -6. Maximum value = +6. Score is an item mean. Higher scores mean better outcomes. | Baseline and 6-month post-baseline |