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OpenTrials
Completed

NCT Number: NCT01270568

Mind-body Interventions in Cardiac Patients

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Congestive Heart Failure Heart Diseases Heart Failure Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive Psychology

Other

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

Relaxation Response

Behavioral

Daily practice of relaxation response, reviewed on a weekly basis

Recollection

Behavioral

Subjects record daily events on a weekly basis for 8 weeks

Primary outcomes

  1. Feasiblity

    Time frame: 8 weeks

    Percentage of exercises completed in the 8 week period

Secondary outcomes

  1. Optimism

    Time frame: 8 weeks

    Self-report (on Likert scale) of optimism

  2. Happiness

    Time frame: 8 week

    Score on Subjective Happiness Scale Score on Happiness subscale of CES-D

  3. Depression

    Time frame: 8 weeks

    Center for Epidemiologic Studies Depression Scale (CES-D)

  4. Anxiety

    Time frame: 8 weeks

    Hospital Anxiety and Depression Scale--Anxiety subscale

  5. Mental-health related quality of life

    Time frame: 8 weeks

    SF-12 Mental Component Score

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 5, 2011
Registry last updated
Jan 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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