Healthy Hearts Healthy Minds

Completed · Not applicable

Conditions studied: Cardiovascular Diseases, Depression

In brief

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 risk of having a heart attack with depression is double that of individuals who do not have depression. Exercise, improves both depression and risk factors for heart disease; yet, most Americans do not exercise regularly, especially those with depression and/or heart disease. This study is important to these individuals as most of them want to exercise, but have difficulty finding the motivation and energy to do so, which has a substantially negative impact on their physical and mental health. This study will compare two empirically supported treatments designed to help individuals with a mood disorder at risk or with heart disease to increase their physical activity as objectively measured by a Fitbit (which we will provide to participants at no cost). This new study, focused on getting people moving, is funded by the Patient Centered Outcome Research Institute (PCORI) and involves 2 Patient Powered Research Networks (PPRNs) known as the MoodNetwork and the Health eHeart Alliance. With the help of patients across the country the Healthy Hearts Healthy Minds study team aims to be able to study the best method to get people to be more physically active - making them happier and healthier in the process.

Key facts

Study ID

NCT03373110

Run by

Massachusetts General Hospital

People needed

506

Starts

2018-02-13

Expected to finish

2019-03-08

Last updated by the study team

2022-02-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dauten Family Center for Bipolar Treatment Innovation — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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