Clinical trial NCT00364910: Safety and Efficacy of Cognitive Behavior Therapy for People With Post-traumatic Stress and Cardiovascular Illness
Official title: Post-Traumatic Stress Disorder (PTSD) Treatment in Cardiac Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Myocardial Infarction (MI)
Cognitive Behavioral Therapy (CBT)
Adherence
Depression
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-08-16
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Average blood pressure
timeFrame: Measured at Months 2 and 6
measure: Impact of Event Scales (IES)
timeFrame: Measured at Months 2 and 6
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: Measured at Months 2 and 6
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Queens
country: United States
facility: Elmhurst Hospital Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Eyal Shemesh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.