Multicomponent Cognitive Behavioral Therapy(CBT) for Posttraumatic Stress Disorder (PTSD) and Substance Abuse (PTSD/SUD)

July 6, 2010 updated by: University of North Carolina, Chapel Hill

Multicomponent Cognitive Behavioral Therapy for Posttraumatic Stress Disorder and Substance Abuse: A Pilot Study

Purpose: To conduct a pilot study of a cognitive-behavioral treatment (CBT) for PTSD and substance abuse among persons with serious mental illness (SMI) treated in a community setting.

Participants: Participants will be 50 volunteer adult individuals with PTSD and substance use disorders (SUD), and SMI who are receiving services at the Freedom House Recovery Center, served through the Orange Person Chatham (OPC) Area Program.

Procedures (methods): Participants will be randomly assigned to one of two conditions: 1) the CBT intervention plus treatment as usual; or, 2) treatment as usual.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • Freedom House

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be at least 18 years of age
  • Currently receiving services at Freedom House
  • Meet DSM-IV criteria for PTSD
  • Meet criteria for Substance Use Disorder
  • Able to understand and provide informed consent

Exclusion Criteria:

• Psychiatric hospitalization or suicide attempt in the past two months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT Intervention
The CBT intervention includes psychoeducation and coping and social skills delivered in a group format, and exposure therapy delivered in individual sessions
Behavioral: CBT and exposure therapy for PTSD
The CBT intervention will be administered twice weekly in group therapy sessions for 7 weeks, and then twice weekly individual sessions for 4 weeks.
Active Comparator: Treatment as Usual
The TAU Condition will receive usual services at the community clinic, which may include medications, individual or group therapy
Other: Treatment as Usual
Participants in the treatment as usual condition will receive their usual services at the community clinic where they receive mental health and substance abuse services

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinician Administered PTSD Scale
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Addiction Severity Index
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Karen J Cusack, PhD, University of North Carolina, Chapel Hill
  • Study Director: William Blair, B.S., University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

December 7, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

July 7, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5K01MH079343 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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