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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00494650 |
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 |
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Post-Traumatic Stress Disorder |
Behavioral: Cognitive behavioral therapy (CBT) Behavioral: Brief PTSD treatment |
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) |
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 |
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1: Experimental
Participants will receive cognitive behavioral therapy.
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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.
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2: Active Comparator
Participants will receive brief PTSD treatment.
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Weili Lu, PhD | luwe1@umdnj.edu | |
Contact: Kim T. Mueser, PhD | 603-271-5747 | kim.t.mueser@dartmouth.edu |
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 |
Principal Investigator: | Kim T. Mueser, PhD | Dartmouth-Hitchcock Medical Center |
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 |
PTSD Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depression |
Schizophrenia Depression Anxiety Disorders Mental Disorders Bipolar Disorder |
Stress Disorders, Post-Traumatic Stress Depressive Disorder, Major Depressive Disorder Stress Disorders, Traumatic |
Pathologic Processes Disease |