search
Back to results

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

Primary Purpose

Posttraumatic Stress Disorder, Substance Abuse

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CBT and exposure therapy for PTSD
Treatment as Usual
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Freedom House

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT Intervention

Treatment as Usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale

Secondary Outcome Measures

Addiction Severity Index

Full Information

First Posted
December 7, 2009
Last Updated
July 6, 2010
Sponsor
University of North Carolina, Chapel Hill
search

1. Study Identification

Unique Protocol Identification Number
NCT01029197
Brief Title
Multicomponent Cognitive Behavioral Therapy(CBT) for Posttraumatic Stress Disorder (PTSD) and Substance Abuse
Acronym
PTSD/SUD
Official Title
Multicomponent Cognitive Behavioral Therapy for Posttraumatic Stress Disorder and Substance Abuse: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Substance Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT Intervention
Arm Type
Experimental
Arm Description
The CBT intervention includes psychoeducation and coping and social skills delivered in a group format, and exposure therapy delivered in individual sessions
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
The TAU Condition will receive usual services at the community clinic, which may include medications, individual or group therapy
Intervention Type
Behavioral
Intervention Name(s)
CBT and exposure therapy for PTSD
Intervention Description
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
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Addiction Severity Index
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen J Cusack, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Blair, B.S.
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Director
Facility Information:
Facility Name
Freedom House
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs