Mind-body Interventions in Cardiac Patients

January 20, 2011 updated by: Massachusetts General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasiblity
Time Frame: 8 weeks
Percentage of exercises completed in the 8 week period
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimism
Time Frame: 8 weeks
Self-report (on Likert scale) of optimism
8 weeks
Happiness
Time Frame: 8 week
Score on Subjective Happiness Scale Score on Happiness subscale of CES-D
8 week
Depression
Time Frame: 8 weeks
Center for Epidemiologic Studies Depression Scale (CES-D)
8 weeks
Anxiety
Time Frame: 8 weeks
Hospital Anxiety and Depression Scale--Anxiety subscale
8 weeks
Mental-health related quality of life
Time Frame: 8 weeks
SF-12 Mental Component Score
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 3, 2011

First Posted (Estimate)

January 5, 2011

Study Record Updates

Last Update Posted (Estimate)

January 21, 2011

Last Update Submitted That Met QC Criteria

January 20, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009P002386

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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