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Clinical Trials/NCT01029197
NCT01029197CompletedPhase 1

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

University of North Carolina, Chapel Hill1 site in 1 country45 target enrollmentStarted: August 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
45
Locations
1
Primary Endpoint
Clinician Administered PTSD Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

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

Intervention: CBT and exposure therapy for PTSD (Behavioral)

Treatment as Usual

Active Comparator

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

Intervention: Treatment as Usual (Other)

Outcomes

Primary Outcomes

Clinician Administered PTSD Scale

Time Frame: 3 months

Secondary Outcomes

  • Addiction Severity Index(3 months)

Investigators

Study Sites (1)

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