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Mind-body Interventions in Cardiac Patients

Primary Purpose

Acute Coronary Syndrome, Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Psychology
Relaxation Response
Recollection
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring positive psychology, cardiovascular disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Positive Psychology

Relaxation Response

Recollection

Arm Description

8 weekly positive psychology exercises

Meditation-based treatment

Recollection of daily events, recorded weekly

Outcomes

Primary Outcome Measures

Feasiblity
Percentage of exercises completed in the 8 week period

Secondary Outcome Measures

Optimism
Self-report (on Likert scale) of optimism
Happiness
Score on Subjective Happiness Scale Score on Happiness subscale of CES-D
Depression
Center for Epidemiologic Studies Depression Scale (CES-D)
Anxiety
Hospital Anxiety and Depression Scale--Anxiety subscale
Mental-health related quality of life
SF-12 Mental Component Score

Full Information

First Posted
January 3, 2011
Last Updated
January 20, 2011
Sponsor
Massachusetts General Hospital
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01270568
Brief Title
Mind-body Interventions in Cardiac Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Congestive Heart Failure
Keywords
positive psychology, cardiovascular disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Positive Psychology
Arm Type
Experimental
Arm Description
8 weekly positive psychology exercises
Arm Title
Relaxation Response
Arm Type
Active Comparator
Arm Description
Meditation-based treatment
Arm Title
Recollection
Arm Type
Sham Comparator
Arm Description
Recollection of daily events, recorded weekly
Intervention Type
Other
Intervention Name(s)
Positive Psychology
Intervention Description
Weekly exercises focused on optimism, gratitude, altruism, and other positive affective states
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Response
Intervention Description
Daily practice of relaxation response, reviewed on a weekly basis
Intervention Type
Behavioral
Intervention Name(s)
Recollection
Intervention Description
Subjects record daily events on a weekly basis for 8 weeks
Primary Outcome Measure Information:
Title
Feasiblity
Description
Percentage of exercises completed in the 8 week period
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Optimism
Description
Self-report (on Likert scale) of optimism
Time Frame
8 weeks
Title
Happiness
Description
Score on Subjective Happiness Scale Score on Happiness subscale of CES-D
Time Frame
8 week
Title
Depression
Description
Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame
8 weeks
Title
Anxiety
Description
Hospital Anxiety and Depression Scale--Anxiety subscale
Time Frame
8 weeks
Title
Mental-health related quality of life
Description
SF-12 Mental Component Score
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Mind-body Interventions in Cardiac Patients

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