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

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT01029197
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 4.5

Study Details

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
• 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: Aug 1, 2009
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

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 [3 months]

Secondary Outcome Measures

1. Addiction Severity Index [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01029197
• Other Study ID Numbers: 5K01MH079343
• First Posted: Dec 9, 2009
• Last Update Posted: Jul 7, 2010
• Last Verified: Jul 1, 2010

• Additional relevant MeSH terms: Substance-Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Jul 7, 2010