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  • Comparing Three Ways to Help People w...

Comparing Three Ways to Help People with Mood Disorders and Heart Disease Risk Increase Their Physical Activity

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Project Summary  

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Mood disorders are mental health conditions that can make it hard to function in daily life. People with mood disorders like depression are at increased risk for other health problems. For example, people with depression are twice as likely to have a heart attack and four times more likely to die from heart disease than people who do not have depression. Exercise can improve symptoms of depression, such as fatigue, and can prevent heart disease. However, it is especially hard for people with mood disorders to find the desire and energy to exercise.

In this study, the research team is comparing three ways to encourage exercise among people with mood disorders who have or who are at risk for heart disease. The first way is cognitive behavioral therapy, or CBT, which helps people change patterns of thinking that may make their conditions worse. The second way is mindfulness-based cognitive therapy, or MCBT, which helps people accept their feelings and be aware of the present moment. The research team is looking to see if online CBT and MCBT programs can help people with mood disorders exercise more compared with the third way, which is regular care.

Who can this research help?

Findings from this study can help doctors decide whether to offer online CBT or MCBT to patients with mood disorders who have or who are at risk for heart disease to help them exercise more.

What is the research team doing?

Using the MoodNetwork and Health eHeart online networks, the research team is recruiting 500 people with mood disorders who have or who are at risk for heart disease. All study participants are receiving a Fitbit™ activity tracker, which tracks how many steps the wearer takes each day.

The research team is assigning participants by chance to receive CBT, MCBT, or Fitbit only. The CBT and MCBT programs are online and last 12 weeks. The goal of both programs is to increase the number of steps people take each day. The team wants to learn how effective these methods are at increasing exercise for different groups of people.

Patients with mood disorders from MoodNetwork and patients with or at risk for heart disease from Health eHeart are helping to tailor the online programs. Patients are also sharing their stories and are helping to recruit people for the study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population English-speaking individuals over 18 years of age who self-identify as having a mood disorder and who have or are at risk for heart disease
Interventions/
Comparators
  • Fitbit plus online CBT
  • Fitbit plus online MCBT
  • Fitbit only
Outcomes

Primary: daily steps

Secondary: depressive symptoms, wellness

Timeframe 3-month follow-up for primary outcome

Project Details

Principal Investigator
Andrew A. Nierenberg, MD
Project Status
In PCORI Peer-Review Process
Project Title
Healthy Hearts Healthy Minds: A PPRN Demonstration Pragmatic Trial
Board Approval Date
March 2016
Project End Date
May 2021
Organization
Massachusetts General Hospital
Year Awarded
2016
State
Massachusetts
Project Type
Research Project
Health Conditions  
Cardiovascular Diseases
Coronary or Ischemic Heart Disease
Mental/Behavioral Health
Bipolar Disorder
Intervention Strategies
Behavioral Interventions
Technology Interventions
Populations
Racial/Ethnic Minorities
Funding Announcement
Patient-Powered Research Networks (PPRN) Research Demonstration Projects
Project Budget
$2,522,180
Study Registration Information
HSRP20163169
NCT03373110
Page Last Updated: 
January 21, 2021

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