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| 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 |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
More Information
| 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 |
|
Psychotic Disorders |
|
Schizophrenia Pathologic Processes Disease Anxiety Disorders Mental Disorders |
Stress Disorders, Post-Traumatic Stress Schizophrenia and Disorders with Psychotic Features Stress Disorders, Traumatic |