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

Schizophrenia Clinical Trial

Official title:

CBT for PTSD and SMI in Community Mental Health Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00078741
• Other study ID #: R21MH065248
• Secondary ID: R21MH065248DSIR
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2004
• Last updated: August 7, 2015
• Start date: January 2004
• Est. completion date: September 2007

Study information

• Verified date: December 2007
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2007
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of PTSD and schizophrenia or schizoaffective disorder

• Active involvement in case management

Exclusion Criteria:

• Suicide risk

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Cognitive Behavioral Therapy (CBT)

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	South Carolina Department of Mental Health	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States,