Safety and Efficacy of Cognitive Behavior Therapy for People With Post-traumatic Stress and Cardiovascular Illness
NCT ID: NCT00364910
Last Updated: 2017-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2006-04-30
2008-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cognitive behavioral therapy (CBT)
Participants will receive cognitive behavioral therapy
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 will receive an educational session and treatment as usual
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Meets the threshold PTSD screening criterion
* Prescribed an anticoagulant or anti-aggregant at least 2 weeks prior to study entry
Exclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Principal Investigators
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Eyal Shemesh, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Elmhurst Hospital Center
Queens, New York, United States
Countries
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References
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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.
Other Identifiers
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03-0985 DAHBR 96-BHC
Identifier Type: -
Identifier Source: secondary_id
GCO 03-0985
Identifier Type: -
Identifier Source: org_study_id