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

Tracking Information
First Received Date ^ICMJE	March 5, 2004
Last Updated Date	December 26, 2007
Start Date ^ICMJE	January 2004
Primary Completion Date	March 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00078741 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder in Individuals With Severe Mental Illness
Official Title ^ICMJE	CBT for PTSD and SMI in Community Mental Health Centers
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.
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 Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Condition ^ICMJE	Stress Disorders, Post-Traumatic Schizophrenia
Intervention ^ICMJE	Behavioral: Cognitive Behavioral Therapy (CBT)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	September 2007
Primary Completion Date	March 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diagnosis of PTSD and schizophrenia or schizoaffective disorder Active involvement in case management Exclusion Criteria: Suicide risk
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00078741
Responsible Party
Study ID Numbers ^ICMJE	R21 MH65248, DSIR 83-ATAS
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP