Mind-body Interventions in Cardiac Patients

Acute Coronary Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270568
• Other study ID #: 2009P002386
• Status: Completed
• Phase: N/A
• First received: January 3, 2011
• Last updated: January 20, 2011
• Start date: March 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Congestive Heart Failure
• Heart Failure

Intervention

Other:
• Positive Psychology
Weekly exercises focused on optimism, gratitude, altruism, and other positive affective states

Behavioral:
• Relaxation Response
Daily practice of relaxation response, reviewed on a weekly basis
• Recollection
Subjects record daily events on a weekly basis for 8 weeks

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasiblity	Percentage of exercises completed in the 8 week period	8 weeks
Secondary	Optimism	Self-report (on Likert scale) of optimism	8 weeks
Secondary	Happiness	Score on Subjective Happiness Scale Score on Happiness subscale of CES-D	8 week
Secondary	Depression	Center for Epidemiologic Studies Depression Scale (CES-D)	8 weeks
Secondary	Anxiety	Hospital Anxiety and Depression Scale--Anxiety subscale	8 weeks
Secondary	Mental-health related quality of life	SF-12 Mental Component Score	8 weeks