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Healthy Hearts Healthy minds: a patient-powered research network (PPRN) demonstration pragmatic trial
Investigator (PI): Nierenberg, Andrew
Performing Organization (PO): (Current): Massachusetts General Hospital, Department of Psychiatry / (617) 724-5600
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2021
Record Source/Award ID: PCORI/PPRND-1507-31449
Funding: Total Award Amount: $2,522,180
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Individuals with depression are four times more likely to die from coronary heart disease than someone who does not have depression. Conversely, the risk of having a heart attack with depression is double that of individuals who do not have depression. Thus, having heart disease and depression puts one at a greater risk for dying. 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 an activity monitor (Fitbit). The MoodNetwork PPRN has partnered with the Health eHeart Alliance to accomplish this goal. We will randomize 500 individuals with a mood disorder at risk of or with cardiovascular disease to either web-based cognitive-behavioral therapy (CBT) or web-based mindfulness-based cognitive therapy (MBCT) to enhance exercise (daily steps as measured by Fitbit). This will help us to better understand which intervention will work best to enhance exercise (aim 1) and for whom (aim 2) as well as create easy-to-access interventions that can be made available to many people after this study is completed. These interventions will be accessible through a patient-powered research network, or MoodNetwork.org, and steps (primary outcome) are measured via the Health eHeart Network. The online interventions and assessment technology generated as part of this project will be made available to the PCORnet Commons to support the needs of all networks. Patient partners with mood disorders from MoodNetwork and those with, or at risk for, heart disease from Health eHeart will assist in designing these online interventions to further tailor them for these at-risk individuals as there are unique factors that make exercising challenging for people who are depressed or at risk for heart disease (e.g., overweight or obese). Our patient partners will also share their stories of success with exercise to demonstrate the feasibility and positive outcomes to others to assist with recruitment. By furthering our understanding of the best strategies to enhance exercise, making them available online, and tailoring them with patient input, we will have a significant public health impact on reducing the risk of death for individuals with depression and at risk for cardiovascular disease.
MeSH Terms:
  • Cardiology /methods
  • Clinical Trials as Topic
  • Cognitive Behavioral Therapy
  • Coronary Disease /*complications
  • Depression /*complications
  • Exercise
  • Exercise Therapy /methods
  • Heart Diseases /therapy
  • Humans
  • Internet
  • Mindfulness
  • Monitoring, Ambulatory /methods
  • Obesity /therapy
  • Outcome Assessment, Health Care
  • Overweight
  • Program Development
  • Randomized Controlled Trials as Topic
  • Risk
Country: United States
State: Massachusetts
Zip Code: 02114
UI: 20163169
Project Status: Ongoing
Record History: ('2020: Project extended to 2021.\n2017: Project extended to 2020.',)