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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00364910
First received: August 15, 2006
Last updated: September 8, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Stress Disorders, Post-Traumatic
 Behavioral: Cognitive behavioral therapy (CBT)
Behavioral: Educational session and treatment as usual
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PTSD Treatment in Cardiac Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 Measures:
  • Beck Depression Inventory (BDI) [ Time Frame: Measured at Months 2 and 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Participants will receive cognitive behavioral therapy
 Behavioral: Cognitive behavioral therapy (CBT)
Participants meet with a therapist for three to five sessions brief exposure-based CBT.
Active Comparator: B
Participants will receive an educational session and treatment as usual
 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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364910

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Elmhurst Hospital Center
Queens, New York, United States
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Eyal Shemesh, MD Mount Sinai School of Medicine
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eyal Shemesh, MD, Children's Hospital of Philadelphia / Mount Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00364910     History of Changes
Other Study ID Numbers: MH071249, 03-0985 DAHBR 96-BHC
Study First Received: August 15, 2006
Last Updated: September 8, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Myocardial Infarction (MI)
Cognitive Behavioral Therapy (CBT)
Adherence
Depression

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013