Text Size

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

This study has been completed.
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01029197
First received: December 7, 2009
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Posttraumatic Stress Disorder
Substance Abuse
 Behavioral: CBT and exposure therapy for PTSD
Other: Treatment as Usual
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicomponent Cognitive Behavioral Therapy for Posttraumatic Stress Disorder and Substance Abuse: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Addiction Severity Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: August 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029197

Locations
United States, North Carolina
Freedom House
Chapel Hill, North Carolina, United States, 27516
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Karen Cusack, Ph.D., University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT01029197     History of Changes
Other Study ID Numbers: 5K01MH079343
Study First Received: December 7, 2009
Last Updated: July 6, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Substance-Related Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013