Mind-body Interventions in Cardiac Patients
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 3, 2011
CompletedFirst Posted
Study publicly available on registry
January 5, 2011
CompletedJanuary 21, 2011
January 1, 2011
10 months
January 3, 2011
January 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasiblity
Percentage of exercises completed in the 8 week period
8 weeks
Secondary Outcomes (5)
Optimism
8 weeks
Happiness
8 week
Depression
8 weeks
Anxiety
8 weeks
Mental-health related quality of life
8 weeks
Study Arms (3)
Positive Psychology
EXPERIMENTAL8 weekly positive psychology exercises
Relaxation Response
ACTIVE COMPARATORMeditation-based treatment
Recollection
SHAM COMPARATORRecollection of daily events, recorded weekly
Interventions
Weekly exercises focused on optimism, gratitude, altruism, and other positive affective states
Daily practice of relaxation response, reviewed on a weekly basis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 3, 2011
First Posted
January 5, 2011
Study Start
March 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
January 21, 2011
Record last verified: 2011-01