Safety and Efficacy of Cognitive Behavior Therapy for People With Post-traumatic Stress and Cardiovascular Illness
Post-Traumatic Stress Disorder (PTSD) Treatment in Cardiac Patients
3 other identifiers
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2006
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 15, 2006
CompletedFirst Posted
Study publicly available on registry
August 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedDecember 26, 2017
December 1, 2017
2 years
August 15, 2006
December 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Beck Depression Inventory (BDI)
Measured at Months 2 and 6
Study Arms (2)
Cognitive behavioral therapy (CBT)
EXPERIMENTALParticipants will receive cognitive behavioral therapy
Educational session and treatment as usual
ACTIVE COMPARATORParticipants will receive an educational session and treatment as usual
Interventions
Participants meet with a therapist for three to five sessions brief exposure-based CBT.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Elmhurst Hospital Center
Queens, New York, 11373, United States
Related 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 disorder resulting from cardiovascular illness. J Clin Psychiatry. 2011 Feb;72(2):168-74. doi: 10.4088/JCP.09m05116blu. Epub 2010 Apr 6.
PMID: 20441725RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eyal Shemesh, MD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2006
First Posted
August 16, 2006
Study Start
April 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
December 26, 2017
Record last verified: 2017-12