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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. |
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| 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. |
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| 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 ] |
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| 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 ] |
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| Condition † | Post-Traumatic Stress Disorder | ||||||||
| Intervention † | Behavioral: Cognitive behavioral therapy (CBT) Behavioral: Brief PTSD treatment |
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| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 200 | ||||||||
| Start Date † | April 2008 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| 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) | ||||||||
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| Investigators † |
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| 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 | ||||||||