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| Tracking Information | |||||
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| First Received Date ICMJE | August 15, 2006 | ||||
| Last Updated Date | September 8, 2008 | ||||
| Start Date ICMJE | April 2006 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00364910 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Beck Depression Inventory (BDI) [ Time Frame: Measured at Months 2 and 6 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Beck Depression Inventory (BDI) | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Efficacy of Cognitive Behavior Therapy for People With Post-Traumatic Stress and Cardiovascular Illness | ||||
| Official Title ICMJE | 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 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 ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Stress Disorders, Post-Traumatic | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | April 2008 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00364910 | ||||
| Responsible Party | Eyal Shemesh, MD, Children's Hospital of Philadelphia / Mount Sinai Medical Center | ||||
| Study ID Numbers ICMJE | MH071249, 03-0985 DAHBR 96-BHC | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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