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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

December 7, 2009
July 6, 2010
August 2009
June 2010   (final data collection date for primary outcome measure)
Clinician Administered PTSD Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01029197 on ClinicalTrials.gov Archive Site
Addiction Severity Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multicomponent Cognitive Behavioral Therapy(CBT) for Posttraumatic Stress Disorder (PTSD) and Substance Abuse
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Posttraumatic Stress Disorder
  • Substance Abuse
  • 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.
  • 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
  • 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
    Intervention: Behavioral: CBT and exposure therapy for PTSD
  • Active Comparator: Treatment as Usual
    The TAU Condition will receive usual services at the community clinic, which may include medications, individual or group therapy
    Intervention: Other: Treatment as Usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01029197
5K01MH079343
No
Karen Cusack, Ph.D., University of North Carolina at Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Karen J Cusack, PhD University of North Carolina, Chapel Hill
Study Director: William Blair, B.S. University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP