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Cognitive Behavioral Treatment for Post-Traumatic Stress Disorder in People With Additional Serious Mental Illnesses

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Cognitive Behavioral Treatment for Post-Traumatic Stress Disorder in People With Additional Serious Mental Illnesses
Official Title  Cognitive Behavioral Treatment of Post-Traumatic Stress Disorder in Clients With Severe Mental Illness (in New Jersey)
Brief Summary

This study will evaluate the effectiveness of tailored cognitive behavioral therapy in treating post-traumatic stress disorder in people with additional mental illnesses.

Detailed Description

Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after experiencing a terrifying event or ordeal in which grave physical harm occurred or was threatened. People with PTSD have persistent frightening thoughts and memories about the traumatic event and may experience sleep problems, feel detached or numb, or be easily startled. Studies have shown that PTSD occurs at high rates among people with serious mental illnesses (SMI), such as bipolar disorder, schizophrenia, and major depression. Research has also proven that cognitive behavioral therapy (CBT) is an effective PTSD treatment for caucasians living in rural areas when it is administered by a PhD-level clinician. It is not clear, however, how successful this treatment will be when it is delivered to a minority population by frontline mental health clinicians in an urban setting. This study will evaluate the effectiveness of tailored CBT in treating PTSD in people with additional mental illnesses who live in urban areas of New Jersey.

Participants in this 4- to 5-month open-label study will be randomly assigned to receive either brief PTSD treatment or CBT. Participants assigned to brief PTSD treatment will have three meetings with a therapist per week. Participants will learn about PTSD, how symptoms may be affecting their lives, and a technique for reducing anxiety associated with PTSD. Participants assigned to CBT will attend 12 to 16 counseling sessions per week or every other week. Participants will learn about PTSD and ways to decrease anxiety associated with PTSD by completing homework assignments and practicing skills learned in counseling sessions. Outcomes will be assessed for all participants through interviews that will occur immediately post-treatment, 6 months post-treatment, and 1 year post-treatment.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs [ Time Frame: Measured post-treatment and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
Depression, anxiety, and other psychiatric symptoms [ Time Frame: Measured post-treatment and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
PTSD diagnoses and symptom severity [ Time Frame: Measured post-treatment and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Total cost for mental health and substance abuse treatment services utilization within the University Behavioral Health Care system [ Time Frame: Measured post-treatment and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
Quality of life and community functioning [ Time Frame: Measured post-treatment and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]
Condition  Post-Traumatic Stress Disorder
Intervention  Behavioral: Cognitive behavioral therapy (CBT)
Behavioral: Brief PTSD treatment
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  200
Start Date  April 2008
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • Meets New Jersey definition of severe mental illness (SMI), which includes a DSM-IV diagnosis of an SMI; within the 3 to 6 months prior to study entry, functional limitations in major life activities that would be appropriate for the client's developmental stage; and within 2 years prior to study entry, two or more treatment episodes of greater intensity than outpatient services (such as inpatient, emergency, or partial hospitalization care, or a single episode lasting 3 months or more) OR a normal living situation disrupted to the point that supportive services were required to maintain the patient in their home or residence, or law enforcement officials were required to intervene
  • DSM-IV Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression (as determined by Structured Clinical Interview)
  • Diagnosis of current severe PTSD at baseline assessment (as determined by a score greater than 65 on a Clinician Administered PTSD Scale)
  • Speaks English

Exclusion Criteria:

  • Current diagnosis of alcohol or drug dependence
  • Hospitalization or suicide attempt in the past 2 months
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Weili Lu, PhD         luwe1@umdnj.edu    
Contact: Kim T. Mueser, PhD     603-271-5747     kim.t.mueser@dartmouth.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00494650
Organization ID R01 MH64662-04
Secondary IDs †† DSIR 83-ATIT
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Kim T. Mueser, PhD     Dartmouth-Hitchcock Medical Center    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date April 2008
First Received Date  June 28, 2007
Last Updated Date April 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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