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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364910
• Other study ID #: GCO 03-0985
• Secondary ID: R34MH07124903-09
• Status: Completed
• Phase: N/A
• First received: August 15, 2006
• Last updated: December 21, 2017
• Start date: April 2006
• Est. completion date: April 2008

Study information

• Verified date: December 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Cognitive behavioral therapy (CBT)
Participants meet with a therapist for three to five sessions brief exposure-based CBT.
• 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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Elmhurst Hospital Center	Queens	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 disorde — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average blood pressure		Measured at Months 2 and 6
Primary	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	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