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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667119
• Other study ID #: 16-101-2
• Secondary ID: K23DA034879
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: June 16, 2021

Study information

• Verified date: August 2022
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 16, 2021
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Use Disorder
• Substance-Related Disorders

Intervention

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.
• Standard Care
Standard care will consist of treatment as usual in a community-based substance use treatment center.

Locations

Country	Name	City	State
United States	UConn Health	Farmington	Connecticut
United States	The Village for Families and Children - Adult Services	Hartford	Connecticut
United States	Farrell Treatment Center	New Britain	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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