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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Clinician Administered PTSD Scale [ Time Frame: 3 months ]
- Addiction Severity Index [ Time Frame: 3 months ]
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|
|Chapel Hill, North Carolina, United States, 27516|
|Principal Investigator:||Karen J Cusack, PhD||University of North Carolina, Chapel Hill|
|Study Director:||William Blair, B.S.||University of North Carolina, Chapel Hill|