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

Not Applicable

Completed

• Conditions: Substance Use Disorder; Posttraumatic Stress Disorder
• Interventions: Behavioral: Prolonged Exposure with Contingency Management; Behavioral: Standard Care

• Registration Number: NCT02667119
• Lead Sponsor: UConn Health

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-28
• Study Start: 2016-04
• Primary Completion: 2021-06-16
• Study Completion: 2021-06-16
• Results First Submitted: 2022-06-16
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-29
• Last Update Submitted: 2022-08-29
• Results First Posted: 2022-09-22
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolonged Exposure + Contingency Management	Standard Care	Standard services plus Prolonged Exposure and Contingency Management
Standard Care	Standard Care	Standard substance abuse treatment services
Prolonged Exposure + Contingency Management	Prolonged Exposure with Contingency Management	Standard services plus Prolonged Exposure and Contingency Management

Primary Outcome Measures

Name	Time	Method
Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale	Baseline and 6-month post-baseline	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).
Longest Duration of Abstinence From Illicit Drugs (Physiological Measure - Urine Drug Screens)	10 week treatment period	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.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

UConn Health; 🇺🇸 Farmington, Connecticut, United States

Farrell Treatment Center; 🇺🇸 New Britain, Connecticut, United States

The Village for Families and Children - Adult Services; 🇺🇸 Hartford, Connecticut, United States