Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder in Individuals With Severe Mental Illness

August 7, 2015 updated by: Medical University of South Carolina

CBT for PTSD and SMI in Community Mental Health Centers

This study will develop a cognitive behavioral therapy (CBT) program to treat symptoms of post-traumatic stress disorder (PTSD) in people with severe mental illnesses who are treated within community mental health systems.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A significant proportion of people with SMI who are treated within the public sector also suffer from PTSD. Evidence suggests that these individuals often receive inadequate mental health services because effective treatments have not been explored. This study will develop and implement a CBT treatment that is designed specifically for the SMI/PTSD population.

In the first year of the study, a treatment manual and a CBT treatment model, including education, social skills training, and exposure therapy, will be developed. In the following two years, the treatment program will be tested in individuals with SMI and PTSD. Scale ratings, self-report checklists, and daily logs of behavior will be used to assess PTSD symptoms. Scale ratings and self-report surveys will also be used to measure hostility, functional status, depression and schizophrenia symptoms, and satisfaction with the study. Assessments will be made throughout the study.

Study Type

Interventional

Enrollment

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Medical University of South Carolina
      • Columbia, South Carolina, United States, 29202
        • South Carolina Department of Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of PTSD and schizophrenia or schizoaffective disorder
  • Active involvement in case management

Exclusion Criteria:

  • Suicide risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Christopher Frueh, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (ACTUAL)

March 1, 2006

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

March 5, 2004

First Submitted That Met QC Criteria

March 5, 2004

First Posted (ESTIMATE)

March 8, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

August 10, 2015

Last Update Submitted That Met QC Criteria

August 7, 2015

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21MH065248 (NIH)
  • DSIR 83-ATAS (NIMH Program Class Code)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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