Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder in Individuals With Severe Mental Illness
Primary Purpose
Stress Disorders, Post-Traumatic, Schizophrenia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Psychotic Disorders
Eligibility Criteria
Inclusion Criteria: Diagnosis of PTSD and schizophrenia or schizoaffective disorder Active involvement in case management Exclusion Criteria: Suicide risk
Sites / Locations
- Medical University of South Carolina
- South Carolina Department of Mental Health
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00078741
First Posted
March 5, 2004
Last Updated
August 7, 2015
Sponsor
Medical University of South Carolina
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00078741
Brief Title
Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder in Individuals With Severe Mental Illness
Official Title
CBT for PTSD and SMI in Community Mental Health Centers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Schizophrenia
Keywords
Psychotic Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of PTSD and schizophrenia or schizoaffective disorder
Active involvement in case management
Exclusion Criteria:
Suicide risk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Frueh
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
South Carolina Department of Mental Health
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder in Individuals With Severe Mental Illness
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