Safety and Efficacy of Cognitive Behavior Therapy for People With Post-Traumatic Stress and Cardiovascular Illness
|Stress Disorders, Post-Traumatic||Behavioral: Cognitive behavioral therapy (CBT) Behavioral: Educational session and treatment as usual||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||PTSD Treatment in Cardiac Patients|
- Average blood pressure [ Time Frame: Measured at Months 2 and 6 ]
- Impact of Event Scales (IES) [ Time Frame: Measured at Months 2 and 6 ]
- Beck Depression Inventory (BDI) [ Time Frame: Measured at Months 2 and 6 ]
|Study Start Date:||April 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Participants will receive cognitive behavioral therapy
Behavioral: Cognitive behavioral therapy (CBT)
Participants meet with a therapist for three to five sessions brief exposure-based CBT.
Active Comparator: B
Participants will receive an educational session and treatment as usual
Behavioral: Educational session and treatment as usual
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364910
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Elmhurst Hospital Center|
|Queens, New York, United States|
|Principal Investigator:||Eyal Shemesh, MD||Icahn School of Medicine at Mount Sinai|