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

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00078741

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	CBT for PTSD and SMI in Community Mental Health Centers

Resource links provided by NLM:

MedlinePlus related topics: Mental Health Post-Traumatic Stress Disorder Schizophrenia

U.S. FDA Resources

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

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

National Institute of Mental Health (NIMH)

More Information

No publications provided

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

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

Psychotic Disorders

Additional relevant MeSH terms:

Schizophrenia
Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

Stress Disorders, Post-Traumatic
Stress
Schizophrenia and Disorders with Psychotic Features
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on November 09, 2009