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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00078741
First received: March 5, 2004
Last updated: December 26, 2007
Last verified: December 2007
  Purpose

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 Intervention Phase
Stress Disorders, Post-Traumatic
Schizophrenia
Behavioral: Cognitive Behavioral Therapy (CBT)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CBT for PTSD and SMI in Community Mental Health Centers

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment: 60
Study Start Date: January 2004
Study Completion Date: September 2007
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Suicide risk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078741

Locations
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00078741     History of Changes
Other Study ID Numbers: R21 MH65248, DSIR 83-ATAS
Study First Received: March 5, 2004
Last Updated: December 26, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Psychotic Disorders

Additional relevant MeSH terms:
Schizophrenia
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on July 22, 2014