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

NCT01029197 | Completed Phase 1

• 1 other identifier: 5K01MH079343
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder; Substance Abuse

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale

  3 months

Secondary Outcomes (1)

• Addiction Severity Index

  3 months

Study Arms (2)

CBT Intervention

EXPERIMENTAL

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

Treatment as Usual

ACTIVE COMPARATOR

The TAU Condition will receive usual services at the community clinic, which may include medications, individual or group therapy

Other: Treatment as Usual

Interventions

CBT and exposure therapy for PTSD BEHAVIORAL

The CBT intervention will be administered twice weekly in group therapy sessions for 7 weeks, and then twice weekly individual sessions for 4 weeks.

CBT Intervention

Treatment as Usual OTHER

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

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Psychiatric hospitalization or suicide attempt in the past two months

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

Freedom House

Chapel Hill, North Carolina, 27516, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders

Interventions

Implosive Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Karen J Cusack, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• William Blair, B.S.

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: August 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 7, 2010

Record last verified: 2010-07

Locations

US (1)