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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00078741
Recruitment Status : Completed
First Posted : March 8, 2004
Last Update Posted : August 10, 2015
National Institute of Mental Health (NIMH)
Information provided by:
Medical University of South Carolina

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Schizophrenia Behavioral: Cognitive Behavioral Therapy (CBT) Phase 2

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  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CBT for PTSD and SMI in Community Mental Health Centers
Study Start Date : January 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Suicide risk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00078741

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29401
South Carolina Department of Mental Health
Columbia, South Carolina, United States, 29202
Sponsors and Collaborators
Medical University of South Carolina
National Institute of Mental Health (NIMH)
Principal Investigator: Christopher Frueh Medical University of South Carolina Identifier: NCT00078741     History of Changes
Other Study ID Numbers: R21MH065248 ( U.S. NIH Grant/Contract )
R21MH065248 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2004    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: December 2007

Keywords provided by Medical University of South Carolina:
Psychotic Disorders

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Trauma and Stressor Related Disorders