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

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ClinicalTrials.gov Identifier: NCT00364910
Recruitment Status : Completed
First Posted : August 16, 2006
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

August 15, 2006
August 16, 2006
December 26, 2017
April 2006
April 2008   (Final data collection date for primary outcome measure)
  • Average blood pressure [ Time Frame: Measured at Months 2 and 6 ]
  • Impact of Event Scales (IES) [ Time Frame: Measured at Months 2 and 6 ]
    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)
  • mean arterial blood pressure
  • LDL cholesterol levels
  • Impact of Event Scales (IES)
Complete list of historical versions of study NCT00364910 on ClinicalTrials.gov Archive Site
Beck Depression Inventory (BDI) [ Time Frame: Measured at Months 2 and 6 ]
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.
Beck Depression Inventory (BDI)
Not Provided
Not Provided
 
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
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Stress Disorders, Post-Traumatic
  • Behavioral: Cognitive behavioral therapy (CBT)
    Participants meet with a therapist for three to five sessions brief exposure-based CBT.
  • Behavioral: 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.
  • Experimental: Cognitive behavioral therapy (CBT)
    Participants will receive cognitive behavioral therapy
    Intervention: Behavioral: Cognitive behavioral therapy (CBT)
  • Active Comparator: Educational session and treatment as usual
    Participants will receive an educational session and treatment as usual
    Intervention: Behavioral: Educational session and treatment as usual
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Same as current
April 2008
April 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00364910
GCO 03-0985
R34MH071249 ( U.S. NIH Grant/Contract )
03-0985 DAHBR 96-BHC
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)
Principal Investigator: Eyal Shemesh, MD Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP