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

Phase 1

Completed

• Conditions: Posttraumatic Stress Disorder; Substance Abuse
• Interventions: Behavioral: CBT and exposure therapy for PTSD; Other: Treatment as Usual

• Registration Number: NCT01029197
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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Exclusion Criteria

• Psychiatric hospitalization or suicide attempt in the past two months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT Intervention	CBT and exposure therapy for PTSD	The CBT intervention includes psychoeducation and coping and social skills delivered in a group format, and exposure therapy delivered in individual sessions
Treatment as Usual	Treatment as Usual	The TAU Condition will receive usual services at the community clinic, which may include medications, individual or group therapy

Primary Outcome Measures

Name	Time	Method
Clinician Administered PTSD Scale	3 months

Secondary Outcome Measures

Name	Time	Method
Addiction Severity Index	3 months

Trial Locations

Locations (1)

Freedom House; 🇺🇸 Chapel Hill, North Carolina, United States