Mind-body Interventions in Cardiac Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01270568
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : January 21, 2011
Centers for Disease Control and Prevention
Information provided by:
Massachusetts General Hospital

Brief Summary:

This study is investigating whether a series of psychological exercises, called positive psychology, provides benefit to patients who have been hospitalized for heart disease (an 'acute coronary syndrome' or heart failure).

In this study, subjects are randomly assigned to complete 8 positive psychology exercises over 8 weeks, or to complete different exercises in control groups.

We hypothesize that patients who are assigned to the positive psychology tasks will be able to complete the exercises at a high rate, will feel that the exercises were easy to perform, and will have greater improvements of optimism, anxiety, mood, and health-related quality of life than subjects in the control conditions.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Congestive Heart Failure Other: Positive Psychology Behavioral: Relaxation Response Behavioral: Recollection

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011

Arm Intervention/treatment
Experimental: Positive Psychology
8 weekly positive psychology exercises
Other: Positive Psychology
Weekly exercises focused on optimism, gratitude, altruism, and other positive affective states
Active Comparator: Relaxation Response
Meditation-based treatment
Behavioral: Relaxation Response
Daily practice of relaxation response, reviewed on a weekly basis
Sham Comparator: Recollection
Recollection of daily events, recorded weekly
Behavioral: Recollection
Subjects record daily events on a weekly basis for 8 weeks

Primary Outcome Measures :
  1. Feasiblity [ Time Frame: 8 weeks ]
    Percentage of exercises completed in the 8 week period

Secondary Outcome Measures :
  1. Optimism [ Time Frame: 8 weeks ]
    Self-report (on Likert scale) of optimism

  2. Happiness [ Time Frame: 8 week ]
    Score on Subjective Happiness Scale Score on Happiness subscale of CES-D

  3. Depression [ Time Frame: 8 weeks ]
    Center for Epidemiologic Studies Depression Scale (CES-D)

  4. Anxiety [ Time Frame: 8 weeks ]
    Hospital Anxiety and Depression Scale--Anxiety subscale

  5. Mental-health related quality of life [ Time Frame: 8 weeks ]
    SF-12 Mental Component Score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hospitalization at Massachusetts General Hospital for an acute coronary syndrome or congestive heart failure
  • Able to read/write in English
  • Have working home or cellular phone

Exclusion Criteria:

  • Cognitive disorder
  • Medical condition likely to lead to death within 6 months
  • Illness leading to inabilty to consent or complete study exercises
  • Current or prior participation in positive psychology interventions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01270568

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Centers for Disease Control and Prevention

Responsible Party: Jeff C. Huffman, M.D., Massachusetts General Hospital Identifier: NCT01270568     History of Changes
Other Study ID Numbers: 2009P002386
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: January 21, 2011
Last Verified: January 2011

Keywords provided by Massachusetts General Hospital:
positive psychology
cardiovascular disease

Additional relevant MeSH terms:
Heart Failure
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases