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

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

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).

Study Overview

• Status: Completed
• Conditions: Substance Use Disorder; Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Prolonged Exposure with Contingency Management; Behavioral: Standard Care

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • UConn Health
    • Hartford, Connecticut, United States, 06105
      • The Village for Families and Children - Adult Services
    • New Britain, Connecticut, United States, 06050
      • Farrell Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prolonged Exposure + Contingency Management; Standard services plus Prolonged Exposure and Contingency Management	Behavioral: Prolonged Exposure with Contingency Management; 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.; Behavioral: Standard Care; Standard care will consist of treatment as usual in a community-based substance use treatment center.
Active Comparator: Standard Care; Standard substance abuse treatment services	Behavioral: Standard Care; Standard care will consist of treatment as usual in a community-based substance use treatment center.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Kristyn Zajac, PhD, UConn Health

Publications and helpful links

General Publications

• Zajac K, Sheidow AJ, Davis M. Juvenile Justice, Mental Health, and the Transition to Adulthood: A Review of Service System Involvement and Unmet Needs in the U.S. Child Youth Serv Rev. 2015 Sep 1;56:139-148. doi: 10.1016/j.childyouth.2015.07.014.
• Zajac K, Randall J, Swenson CC. Multisystemic Therapy for Externalizing Youth. Child Adolesc Psychiatr Clin N Am. 2015 Jul;24(3):601-16. doi: 10.1016/j.chc.2015.02.007. Epub 2015 Mar 29.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): June 16, 2021
• Study Completion (Actual): June 16, 2021

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Substance-Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 16-101-2; K23DA034879 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided