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

Primary Purpose

Substance Use Disorder, Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure with Contingency Management
Standard Care
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorder

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UConn Health
  • The Village for Families and Children - Adult Services
  • Farrell Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prolonged Exposure + Contingency Management

Standard Care

Arm Description

Standard services plus Prolonged Exposure and Contingency Management

Standard substance abuse treatment services

Outcomes

Primary Outcome Measures

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).
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).
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.

Secondary Outcome Measures

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).
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).
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.
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.

Full Information

First Posted
January 19, 2016
Last Updated
August 29, 2022
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02667119
Brief Title
Integrated Treatment for Posttraumatic Stress Disorder and Substance Abuse in Young Adults
Official Title
Treating Co-Occurring PTSD and Substance Abuse in High-Risk Transition Age Youth
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
June 16, 2021 (Actual)
Study Completion Date
June 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder, Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolonged Exposure + Contingency Management
Arm Type
Experimental
Arm Description
Standard services plus Prolonged Exposure and Contingency Management
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Standard substance abuse treatment services
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure with Contingency Management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Standard care will consist of treatment as usual in a community-based substance use treatment center.
Primary Outcome Measure Information:
Title
Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale
Description
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).
Time Frame
Baseline and 3-months post-baseline
Title
Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale
Description
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).
Time Frame
Baseline and 6-month post-baseline
Title
Longest Duration of Abstinence From Illicit Drugs (Physiological Measure - Urine Drug Screens)
Description
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.
Time Frame
10 week treatment period
Secondary Outcome Measure Information:
Title
Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale
Description
Center for Epidemiological Studies-Depressed Mood. Minimum value = 0. Maximum value = 60. Higher scores mean worse outcomes (more severe symptoms).
Time Frame
Baseline and 3-month post-baseline
Title
Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale
Description
Center for Epidemiological Studies-Depressed Mood. Minimum value = 0. Maximum value = 60. Higher scores mean worse outcomes (more severe symptoms).
Time Frame
Baseline and 6-month post-baseline
Title
Change in Quality of Life as Measured by the Quality of Life Scale
Description
Quality of Life Scale. Minimum value = -6. Maximum value = +6. Score is an item mean. Higher scores mean better outcomes.
Time Frame
Baseline and 3-month post-baseline
Title
Change in Quality of Life as Measured by the Quality of Life Scale
Description
Quality of Life Scale. Minimum value = -6. Maximum value = +6. Score is an item mean. Higher scores mean better outcomes.
Time Frame
Baseline and 6-month post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristyn Zajac, PhD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
The Village for Families and Children - Adult Services
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Farrell Treatment Center
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26273119
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. doi: 10.1016/j.childyouth.2015.07.014.
Results Reference
background
PubMed Identifier
26092742
Citation
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.
Results Reference
background

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

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