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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.
Verified by National Institute of Mental Health (NIMH), September 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00494650
  Purpose

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


Condition Intervention
Post-Traumatic Stress Disorder
Behavioral: Cognitive behavioral therapy (CBT)
Behavioral: Brief PTSD treatment

MedlinePlus related topics: Anxiety Depression Mental Health Post-Traumatic Stress Disorder
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Cognitive Behavioral Treatment of Post-Traumatic Stress Disorder in Clients With Severe Mental Illness (in New Jersey)

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: April 2008
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive cognitive behavioral therapy.
Behavioral: Cognitive behavioral therapy (CBT)
CBT will include 12 to 16 counseling sessions, occurring weekly 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.
2: Active Comparator
Participants will receive brief PTSD treatment.
Behavioral: Brief PTSD treatment
Brief PTSD treatment will include three weekly meetings with a therapist. Participants will learn about PTSD, how symptoms may be affecting their lives, and a technique for reducing anxiety associated with PTSD.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494650

Contacts
Contact: Weili Lu, PhD luwe1@umdnj.edu
Contact: Kim T. Mueser, PhD 603-271-5747 kim.t.mueser@dartmouth.edu

Locations
United States, New Jersey
University Behavioral HealthCare (UBHC) Extended Treatment Recruiting
New Brunswick, New Jersey, United States, 08901
University Behavioral HealthCare (UBHC) Adult Outpatient Psychiatric Services Recruiting
New Brunswick, New Jersey, United States, 08901
University Behavioral HealthCare (UBHC) Extended Treatment Division - Partial Hospital Program Not yet recruiting
Newark, New Jersey, United States, 07101
University Behavioral HealthCare (UBHC) Extended Treatment Division - Adult Outpatient Psychiatric Services Recruiting
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Investigators
Principal Investigator: Kim T. Mueser, PhD Dartmouth-Hitchcock Medical Center
  More Information

Responsible Party: Dartmouth Medical School; Dartmouth Psychiatric Research Center ( Dr. Kim T. Mueser )
Study ID Numbers: R01 MH64662-04, DSIR 83-ATIT
Study First Received: June 28, 2007
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00494650  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
PTSD
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depression

Study placed in the following topic categories:
Schizophrenia
Depression
Anxiety Disorders
Mental Disorders
Bipolar Disorder
Stress Disorders, Post-Traumatic
Stress
Depressive Disorder, Major
Depressive Disorder
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009