- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00053690
Treatment of Post Traumatic Stress Disorder in Patients With Other Mental Illnesses
Cognitive-Behavioral Treatment of PTSD in SMI Clients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Despite the progress in treating PTSD in the general population and the elevated prevalence of PTSD in people with severe mental illness (SMI), there are no empirically validated treatments designed for patients with comorbid PTSD. The cognitive behavioral treatment provided in this study may improve knowledge of PTSD, decrease distorted beliefs, reduce PTSD symptoms, and improve quality of life.
Participants are randomly assigned to receive either a cognitive behavioral treatment plus standard care for SMI or standard care alone. The cognitive behavioral treatment incorporates several common features, including psychoeducation, relaxation training, and cognitive restructuring. Standard care for SMI includes medication, case management, and psychosocial treatment. PTSD, psychiatric symptoms, health, quality of life, and substance abuse outcomes are measured. Participants' knowledge of PTSD and beliefs about the world are also measured. Participants are assessed at baseline, post-treatment (16 weeks), and at 3- and 6-month follow-ups.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00494650
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Hampshire
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Claremont, New Hampshire, United States, 03301
- Community Mental Health Centers in NH
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Post Traumatic Stress Disorder
- New Hampshire definition of SMI plus DSM-IV Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression
- Case management services and contact with a case manager at least twice a week
Exclusion Criteria:
- Alcohol or drug dependence
- Hospitalization or suicide attempt in the past 2 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kim Mueser, Ph.D., Dartmouth-Hitchcock Medical Center
- Principal Investigator: Stanley Rosenberg, Ph.D., Dartmouth-Hitchcock Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH064662-01 (U.S. NIH Grant/Contract)
- DSIR AT-SP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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