Mind-body Interventions in Cardiac Patients

NCT ID: NCT01270568

Last Updated: 2011-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-01-31

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.

Detailed Description

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Conditions

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Acute Coronary Syndrome Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Positive Psychology

8 weekly positive psychology exercises

Group Type EXPERIMENTAL

Positive Psychology

Intervention Type OTHER

Weekly exercises focused on optimism, gratitude, altruism, and other positive affective states

Relaxation Response

Meditation-based treatment

Group Type ACTIVE_COMPARATOR

Relaxation Response

Intervention Type BEHAVIORAL

Daily practice of relaxation response, reviewed on a weekly basis

Recollection

Recollection of daily events, recorded weekly

Group Type SHAM_COMPARATOR

Recollection

Intervention Type BEHAVIORAL

Subjects record daily events on a weekly basis for 8 weeks

Interventions

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Positive Psychology

Weekly exercises focused on optimism, gratitude, altruism, and other positive affective states

Intervention Type OTHER

Relaxation Response

Daily practice of relaxation response, reviewed on a weekly basis

Intervention Type BEHAVIORAL

Recollection

Subjects record daily events on a weekly basis for 8 weeks

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2009P002386

Identifier Type: -

Identifier Source: org_study_id

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