Mind-body Interventions in Cardiac Patients

Study Overview
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Brief Summary
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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.

Conditions
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Acute Coronary Syndrome, Congestive Heart Failure

Intervention / Treatment
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* Other: Positive Psychology
* Behavioral: Relaxation Response
* Behavioral: Recollection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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positive psychology, cardiovascular disease