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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:
ClinicalTrials.gov Identifier:
NCT01029197
First Posted: December 9, 2009
Last Update Posted: July 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of North Carolina, Chapel Hill
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • Clinician Administered PTSD Scale [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Addiction Severity Index [ Time Frame: 3 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( U.S. NIH Grant/Contract )
First Submitted: December 7, 2009
First Posted: December 9, 2009
Last Update Posted: July 7, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Substance-Related Disorders
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Chemically-Induced Disorders