Status:
COMPLETED
Healthy Hearts Healthy Minds
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Cardiovascular Diseases
Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Healthy Hearts Healthy Minds: An Overview Individuals with depression are four times more likely to die from coronary heart disease than someone who does not have depression. At the same time, the ris...
Detailed Description
Healthy Hearts Healthy Minds: An Overview Individuals with depression are four times more likely to die from coronary heart disease than someone who does not have depression. At the same time, the ris...
Eligibility Criteria
Inclusion
- Ability to give informed consent
- Fluent in English
- Between the ages of 18-65
- Lives in the United States
- Self-report of having experienced depression as assessed by the Mini International Neuropsychiatric Interview (MINI)
- Self report an elevated risk for or of having cardiovascular disease ( \>150 minutes of physical activity a week)
- Registered a personal account with Fitbit prior to enrollment in the study
Exclusion
- Unwilling/unable to comply with study procedures
- Pregnant
- Responds to item 9 (Suicidal ideation) on the PHQ-9 with a 3 or higher (i.e., "Thoughts that you would be better off dead or of hurting yourself in some way on more than half the days")
- Contraindications to exercise or diet interventions as assessed by the DASI
- Already uses a Fitbit device or other activity monitor
- Suffers from repeated episodes of "blacking out" or "fainting"
- Survived a cardiac arrest or sudden death
- Has recurrent chest discomfort with activity that goes away within 10 minutes of rest or with nitroglycerin
- Has heart failure
- Has been hospitalized recently (within past 6 weeks) for a cardiovascular problem
Key Trial Info
Start Date :
February 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2019
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT03373110
Start Date
February 13 2018
End Date
March 8 2019
Last Update
February 2 2022
Active Locations (1)
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1
Dauten Family Center for Bipolar Treatment Innovation
Boston, Massachusetts, United States, 02114