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NCT01029197 Clinical Trial

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

Posttraumatic Stress Disorder Clinical Trial

— PTSD/SUD  

Official title:
Multicomponent Cognitive Behavioral Therapy for Posttraumatic Stress Disorder and Substance Abuse: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01029197
Other study ID # 5K01MH079343
Secondary ID
Status Completed
Phase Phase 1
First received December 7, 2009
Last updated July 6, 2010
Start date August 2009
Est. completion date June 2010

Study information
Verified date July 2010
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Freedom House Chapel Hill North Carolina

Sponsors (1)
Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinician Administered PTSD Scale 3 months No
Secondary Addiction Severity Index 3 months No
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