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NCT00053690 Clinical Trial

Treatment of Post Traumatic Stress Disorder in Patients With Other Mental Illnesses

Stress Disorders, Post-Traumatic Clinical Trial

Official title:
Cognitive-Behavioral Treatment of PTSD in SMI Clients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00053690
Other study ID # R01MH064662-01
Secondary ID R01MH064662-01DS
Status Completed
Phase N/A
First received February 4, 2003
Last updated September 9, 2013
Start date January 2002
Est. completion date December 2004

Study information
Verified date February 2009
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to develop an effective treatment for people with Post Traumatic Stress Disorder (PTSD) along with other mental illnesses.

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

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Cognitive Behavior Treatment

Locations
Country Name City State
United States Community Mental Health Centers in NH Claremont New Hampshire

Sponsors (2)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

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