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

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ClinicalTrials.gov Identifier: NCT01029197
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : July 7, 2010
Information provided by:

Study Description
Brief Summary:

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
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
Study Start Date : August 2009
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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

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

Eligibility Criteria

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

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

United States, North Carolina
Freedom House
Chapel Hill, North Carolina, United States, 27516
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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 Posted: December 9, 2009    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

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