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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH071249 | U.S. NIH Grant/Contract | View source | |
| 03-0985 DAHBR 96-BHC |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive behavioral therapy (CBT) | Experimental | Participants will receive cognitive behavioral therapy |
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| Educational session and treatment as usual | Active Comparator | Participants will receive an educational session and treatment as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy (CBT) | Behavioral | Participants meet with a therapist for three to five sessions brief exposure-based CBT. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average blood pressure | Measured at Months 2 and 6 | |
| Impact of Event Scales (IES) | A 22-item self-report questionnaire measuring PTSD symptoms. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score ranging from 0 (not at all) to 88 (extremely) | Measured at Months 2 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory (BDI) | a 21 item self-report inventory measuring the severity of depression. Individuals are asked to respond to each question based on a two-week time period. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms. | Measured at Months 2 and 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eyal Shemesh, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States | ||
| Elmhurst Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20441725 | Result | Shemesh E, Annunziato RA, Weatherley BD, Cotter G, Feaganes JR, Santra M, Yehuda R, Rubinstein D. A randomized controlled trial of the safety and promise of cognitive-behavioral therapy using imaginal exposure in patients with posttraumatic stress disorder resulting from cardiovascular illness. J Clin Psychiatry. 2011 Feb;72(2):168-74. doi: 10.4088/JCP.09m05116blu. Epub 2010 Apr 6. |
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| Educational session and treatment as usual | Behavioral | Participants assigned to the educational session attend one meeting with a researcher to discuss the results from their evaluation. They could also be referred to a mental health clinic of their choice to help relieve their symptoms. |
|
| Queens |
| New York |
| 11373 |
| United States |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D009203 | Myocardial Infarction |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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