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

Icahn School of Medicine at Mount Sinai60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive behavioral therapy (CBT)BEHAVIORAL

Participants meet with a therapist for three to five sessions brief exposure-based CBT.

Educational session and treatment as usualBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (2)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Elmhurst Hospital Center

Queens, New York, United States

Outcomes

Primary Outcomes

Average blood pressure

Time frame: 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)

Time frame: Measured at Months 2 and 6

Secondary Outcomes

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.

Time frame: Measured at Months 2 and 6

Data from ClinicalTrials.gov

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