Treatment of Post Traumatic Stress Disorder in Patients With Other Mental Illnesses
Primary Purpose
Stress Disorders, Post-Traumatic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Comorbidity, Schizophrenia, Bipolar Disorder, Depression
Eligibility Criteria
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
Sites / Locations
- Community Mental Health Centers in NH
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00053690
First Posted
February 4, 2003
Last Updated
September 9, 2013
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00053690
Brief Title
Treatment of Post Traumatic Stress Disorder in Patients With Other Mental Illnesses
Official Title
Cognitive-Behavioral Treatment of PTSD in SMI Clients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
Comorbidity, Schizophrenia, Bipolar Disorder, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Mueser, Ph.D.
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stanley Rosenberg, Ph.D.
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Mental Health Centers in NH
City
Claremont
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29040946
Citation
Mueser KT, McGurk SR, Xie H, Bolton EE, Jankowski MK, Lu W, Rosenberg SD, Wolfe R. Neuropsychological predictors of response to cognitive behavioral therapy for posttraumatic stress disorder in persons with severe mental illness. Psychiatry Res. 2018 Jan;259:110-116. doi: 10.1016/j.psychres.2017.10.016. Epub 2017 Oct 6.
Results Reference
derived
Learn more about this trial
Treatment of Post Traumatic Stress Disorder in Patients With Other Mental Illnesses
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