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

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Safety and Efficacy of Cognitive Behavior Therapy for People With Post-Traumatic Stress and Cardiovascular Illness
Official Title  PTSD Treatment in Cardiac Patients
Brief Summary

This study will evaluate the safety and efficacy of cognitive behavioral therapy in treating people who are experiencing post-traumatic stress disorder (PTSD) 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.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Average blood pressure [ Time Frame: Measured at Months 2 and 6 ] [ Designated as safety issue: Yes ]
Impact of Event Scales (IES) [ Time Frame: Measured at Months 2 and 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Beck Depression Inventory (BDI) [ Time Frame: Measured at Months 2 and 6 ] [ Designated as safety issue: No ]
Condition  Stress Disorders, Post-Traumatic
Intervention  Behavioral: Cognitive behavioral therapy (CBT)
Behavioral: Educational session and treatment as usual
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  60
Start Date  April 2006
Completion Date April 2008
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
Gender Both
Ages 21 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Rachel Annunziato, PhD     212-659-9143     rachel.annunziato@mssm.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00364910
Organization ID MH071249
Secondary IDs †† 03-0985 DAHBR 96-BHC
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Eyal Shemesh, MD     Mount Sinai School of Medicine    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date February 2008
First Received Date  August 15, 2006
Last Updated Date February 29, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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