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

NCT ID: NCT01029197

Last Updated: 2010-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-06-30

Brief Summary

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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

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Conditions

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Posttraumatic Stress Disorder Substance Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT Intervention

The CBT intervention includes psychoeducation and coping and social skills delivered in a group format, and exposure therapy delivered in individual sessions

Group Type EXPERIMENTAL

CBT and exposure therapy for PTSD

Intervention Type 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.

Treatment as Usual

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

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type 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

Interventions

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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.

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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University of North Carolina at Chapel Hill

Principal Investigators

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Karen J Cusack, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

William Blair, B.S.

Role: STUDY_DIRECTOR

University of North Carolina, Chapel Hill

Locations

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Freedom House

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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5K01MH079343

Identifier Type: NIH

Identifier Source: org_study_id

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