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Mind-body Interventions in Cardiac Patients

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01270568
First received: January 3, 2011
Last updated: January 20, 2011
Last verified: January 2011
History of Changes
  Purpose

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 Intervention
Acute Coronary Syndrome
Congestive Heart Failure
 Other: Positive Psychology
Behavioral: Relaxation Response
Behavioral: Recollection

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Feasiblity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Percentage of exercises completed in the 8 week period


Secondary Outcome Measures:
  • Optimism [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Self-report (on Likert scale) of optimism

  • Happiness [ Time Frame: 8 week ] [ Designated as safety issue: No ]
    Score on Subjective Happiness Scale Score on Happiness subscale of CES-D

  • Depression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Center for Epidemiologic Studies Depression Scale (CES-D)

  • Anxiety [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale--Anxiety subscale

  • Mental-health related quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    SF-12 Mental Component Score


Estimated Enrollment: 60
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270568

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

No publications provided

Responsible Party: Jeff C. Huffman, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01270568     History of Changes
Other Study ID Numbers: 2009P002386
Study First Received: January 3, 2011
Last Updated: January 20, 2011
Health Authority: United States: Institutional Review Board

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
 Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013