Healthy Hearts Healthy Minds
Condition: Cardiovascular Diseases; Depression
MeSH terms: Cardiovascular Diseases; Depression
Study type: Interventional

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 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.
    

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 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.

      What is the purpose of the study? Healthy Hearts Healthy Minds aims to compare two kinds of
      empirically supported treatment programs to see which is most effective at motivating people
      to be more physically active and increasing well-being: an online, standard, eight-week
      mindfulness training and an online, eight-session "cognitive-behavioral" training. The study
      may also tell us what groups of people do better with one or the other program.

      How does the study work? 500 participants will be recruited from the MoodNetwork and the
      Health eHeart Alliance. They will be randomly assigned to either the mindfulness training,
      the cognitive-behavioral training, or a control group. Participants, regardless of group
      assignment, will receive a Fitbit Charge II at no cost.

      All participants will fill out standard well-being and safety assessments every other week
      for eight weeks to see how they are doing. Participants will also do follow-up assessments
      after sixteen weeks has elapsed since starting the study. All sessions and assessments will
      be done online.

      You may qualify if:

        -  You are physically active less than 150 minutes per week

        -  Have a body mass index (BMI) greater than 25kg/m2

        -  You possess an internet enabled device (e.g. smartphone, tablet/iPad, or desktop) with
           the Fitbit app and a registered personal account with Fitbit

      What does participation involve?

        -  Wearing a FitBit Charge II throughout the duration of the 16 week study

        -  Filling out questionnaires via a secure, online system

        -  Potentially participating in additional weekly program sessions for 8 weeks, depending
           on which program you are assigned to.
    

Intervention name(s): Online Mindfulness Based Cognitive Therapy; Online Cognitive Behavioral Therapy; Fitbit Alone
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): see arm description; see arm description; see arm description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Online Therapy; Fitbit; Depression; Cardiovascular Disease