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| Descriptive Information Fields | |||||
| Brief Title † | Safety and Efficacy of Cognitive Behavior Therapy for People With Post-Traumatic Stress and Cardiovascular Illness | ||||
| Official Title † | PTSD Treatment in Cardiac Patients | ||||
| Brief Summary | This study will evaluate the safety and efficacy of cognitive behavioral therapy in treating people who are experiencing post-traumatic stress disorder (PTSD) after a heart attack. |
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| Detailed Description | PTSD usually develops in people who have experienced a traumatic or life-threatening event, including a health scare like a heart attack or catheterization. Symptoms of PTSD typically include anxiety, anger, and flashbacks or nightmares. PTSD symptoms are also associated with poor medical outcomes and nonadherence to medication after a heart attack. Fortunately, PTSD can sometimes be treated by antidepressants, anti-anxiety medication, and talk therapy. This study will compare the efficacy of cognitive-behavioral therapy (CBT) versus education and treatment as usual for treating people who are experiencing PTSD that is related to their cardiovascular illness (a heart attack or an invasive procedure such as catheterization). Participants in this single-blind study will receive a psychiatric evaluation during which post-traumatic symptoms and feelings regarding their cardiovascular illness will be evaluated. Participants will then be randomly assigned to receive either CBT or a single educational session about PTSD, with up to 2 more follow-up educational meetings if needed. Participants assigned to the educational session will attend one meeting with a researcher to discuss the results from their evaluation. If they choose, they will also be referred to a mental health clinic for further care. Participants assigned to receive CBT will meet with a therapist once a week for at least 3 weeks. Participants will be offered the chance to meet with their therapist for two additional sessions if they need more time to discuss their symptoms. All participants will be re-evaluated at Months 2 and 6 using an interview, questionnaires,blood tests, blood pressure readings, and weight measurements. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Average blood pressure [ Time Frame: Measured at Months 2 and 6 ] [ Designated as safety issue: Yes ] Impact of Event Scales (IES) [ Time Frame: Measured at Months 2 and 6 ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Beck Depression Inventory (BDI) [ Time Frame: Measured at Months 2 and 6 ] [ Designated as safety issue: No ] | ||||
| Condition † | Stress Disorders, Post-Traumatic | ||||
| Intervention † | Behavioral: Cognitive behavioral therapy (CBT) Behavioral: Educational session and treatment as usual |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 60 | ||||
| Start Date † | April 2006 | ||||
| Completion Date | April 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00364910 | ||||
| Organization ID | MH071249 | ||||
| Secondary IDs †† | 03-0985 DAHBR 96-BHC | ||||
| 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 | February 2008 | ||||
| First Received Date † | August 15, 2006 | ||||
| Last Updated Date | February 29, 2008 | ||||