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

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.

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