Safety and Efficacy of Cognitive Behavior Therapy for People With Post-traumatic Stress and Cardiovascular Illness

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post-Traumatic Stress Disorder (PTSD) Treatment in Cardiac Patients

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy (CBT)
* Behavioral: Educational session and treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suffered an acute heart attack or invasive treatment procedure related to a cardiovascular illness within 2 to 12 months of study entry Meets the threshold PTSD screening criterion Prescribed an anticoagulant or anti-aggregant at least 2 weeks prior to study entry Exclusion Criteria: Readmitted to the hospital due to cardiovascular complications within 2 months of study entry Medically unstable Not prescribed aspirin Does not identify an event related to the cardiovascular illness as the primary trauma Cannot take care of self and is dependent on a caretaker for adherence to medications or clinic visits Suffers from other medical illnesses, including diseases that cause significant cognitive impairment (e.g., severe Alzheimer's), diseases that cause severe psychotic symptoms leading to disorientation (e.g., hepatic encephalopathy), diseases that cause brittle and uncontrollable blood pressure (e.g., pheochromocytoma), and diseases that cause uncontrollable hypercholesterolemia (e.g., severe familial hypercholesterolemia) Suicidal or history of suicide attempt Psychotic or suffers from a psychotic spectrum disorder Receiving psychotropic medications or psychotherapy and changed dosage or frequency of treatment within 2 weeks of study entry Currently receiving CBT

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioral therapy (CBT)<br>Participants will receive cognitive behavioral therapy | Behavioral: Cognitive behavioral therapy (CBT)<br>* Participants meet with a therapist for three to five sessions brief exposure-based CBT.<br>|
| Active Comparator: Educational session and treatment as usual<br>Participants will receive an educational session and treatment as usual | Behavioral: Educational session and treatment as usual<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Infarction (MI), Cognitive Behavioral Therapy (CBT), Adherence, Depression