Healthy Hearts Healthy Minds

Study Overview
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Brief Summary
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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
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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.

Official Title
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Healthy Hearts Healthy Minds: A PPRN Demonstration Pragmatic Trial

Conditions
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Cardiovascular Diseases, Depression

Intervention / Treatment
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* Behavioral: Online Mindfulness Based Cognitive Therapy
* Behavioral: Online Cognitive Behavioral Therapy
* Behavioral: Fitbit Alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online Mindfulness Based Cognitive Therapy +Fitbit<br>A central aspect of MBCT is the concept of awareness. Participants practice a variety of meditation types (e.g. breath awareness) and learn to bring mindfulness to everyday situations. Awareness will be directed to elements in participants' lives that interfere with living a more productive, physically active life (e.g. thoughts and feelings that interfere with becoming more physically active; stressful situations and circumstances that prevent them from engaging in exercise). Two hundred participants will be randomized into this group. | Behavioral: Online Mindfulness Based Cognitive Therapy<br>* see arm description<br>|
| Experimental: Online Cognitive Behavioral Therapy +Fitbit<br>1)identifying and setting realistic exercise-based goals and intermediate goals (to maximize success to increase motivation); (2) behavioral scheduling to optimize when to exercise, identify rewards for exercising, and problem solve obstacles to exercising; and (3) identify dysfunctional, maladaptive thoughts about exercise (which decrease motivation) and skills to identify more adaptive, positive thoughts (to overcome thoughts of being too tired or too stressed to exercise). Two hundred participants will be randomized into this group. | Behavioral: Online Cognitive Behavioral Therapy<br>* see arm description<br>|
| Active Comparator: Fitbit Alone<br>Participants assigned to the Fitbit-only control study group you will not be receiving therapy. However, they will receive a Fitbit, which they will be asked to wear over the course of 16 weeks as well as to complete the same schedule of assessments as the therapy arms. One hundred participants will be randomized into this group. | Behavioral: Fitbit Alone<br>* see arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (Per Day) in Average Daily Steps From Baseline | Participants randomized to the CBT+fitbit and MBCT+fitbit groups completed 8 weeks of online intervention sessions with biweekly questionnaires whereas participants in the fitbit only group completed 8 weeks of biweekly questionnaires alone. After the first 8 weeks of the study, participants received no new online intervention material (regardless of their initial group assignment), but were instructed to continue wearing their fitbit for the remaining 8 weeks of the study and the MBCT+fitbit and CBT+fitbit groups continued to have access to the intervention material presented in the first 8 weeks of the study. At week 16, participants completed a follow-up assessment. The Fitbit records start and stop times of the day (e.g., indicating when participants were in bed) and therefore, steps were only counted during these times. Participants without any step count data for a given day were treated as missing values for that day. | Baseline, 8 weeks, and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9) | Change per day in average daily steps stratified by the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9 item self-report measure assessing presence of depression. Individuals are asked to rank how often they have experienced each item over the past two weeks on a scale from 0 (not at all) - 3 (nearly every day). Possible total scores range from 0-27, with higher scores indicate higher levels of depression. The PHQ-9 is a continuous measure and thus, was left continuous in our model and was not categorized. Because the PHQ-9 is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected scores of 5, 10, and 15 as values to report the model-based slopes. | Baseline, 8 and 16 weeks | 
| Change (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM) | Change per day in average daily steps stratified by the Altman Self-Rating Mania Scale (ASRM), specifically using summed scores of 0,1, and 3. 5-item self rating scale, designed to asses the presence and/or severity of manic symptoms. Each item can be scored from 0-4. Possible total scores range from 0-25, and a score of 6 or higher indicates a high probability of a manic or hypomanic condition. The ASRM is a continuous measure and thus, was left continuous in our model and was not categorized. Because the ASRM is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected scores of 0, 1, and 3 as values to report the model-based slopes. | Baseline, 8 and 16 weeks | 
| Change (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5) | Change per day in average daily steps stratified by the Well Being Index (WHO-5). 5 item self report measure (rated on a 6 point Likert scale) to assess quality of life. Possible total scores range from 0-100 with 0 representing worst possible quality of life and 100 representing best possible quality of life. The WHO-5 is a continuous measure and thus, was left continuous in our model and was not categorized. Because the WHO-5 is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected scores of 15, 30, and 45 as values to report the model-based slopes. | Baseline, 8 and 16 weeks | 
| Change (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS) | Change per day in average daily steps stratified by the Perceived Stress Scale (PSS), specifically using scores of 15, 20, and 25. 10 item scale (rated 0-4) that aims to measure the degree to which situations in one's life are appraised as stressful. Possible total scores range from 0-40 with higher scores are associated with higher levels of perceived stress. The PSS is a continuous measure and thus, was left continuous in our model and was not categorized. Because the PSS is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected scores of 15, 20, and 25 as values to report the model-based slopes. | Baseline, 8 and 16 weeks | 
| Change (Per Day) in Average Daily Steps Stratified by Age | Change per day in average daily steps stratified by age. Participants self-reported age on the demographics form. Age is a continuous measure and thus, was left continuous in our model and was not categorized. Because age is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected ages of 35, 45, and 55 as values to report the model-based slopes. | Baseline, 8 and 16 weeks | 
| Change (Per Day) in Average Daily Steps Stratified by Sex | Change per day in average daily steps stratified by sex. Participants self-reported male or female on the demographics form. | Baseline, 8 and 16 weeks | 
| Change (Per Day) in Average Daily Steps Stratified by Anxiety | Change per day in average daily steps stratified by anxiety. Comorbid anxiety was self-reported in the psychiatric history questionnaire. | Baseline, 8 and 16 weeks | 
| Change (Per Day) in Average Daily Steps Stratified by Smoking | Change per day in average daily steps stratified by smoking status. Smoker or non-smoker was self-reported on the psychiatric history questionnaire. | Baseline, 8 and 16 weeks | 
| Change (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE) | Change per day in average daily steps stratified by Self-efficacy for exercise (SEE), specifically using scores of 30, 45, and 55. Possible total scores range from 0-90. This 9-item measure, administered at study randomization, asks participants to indicate their self-confidence that they could exercise three times per week for twenty minutes under a variety of conditions. Sample items include being able to exercise if You were bored by the program or activity and The weather was bothering you. Higher total scores on this measure reflect increased self-efficacy for exercise. The SEE is a continuous measure and thus, was left continuous in our model and was not categorized. Because the SEE is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected scores of 30, 45, and 55 as values to report the model-based slopes. | Baseline, 8 and 16 weeks | 
| Change (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI) | Change (per day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI), specifically using summed scores of 40, 50, and 60. Possible total scores range from 0-58.2. This 12-item questionnaire, administered at the screening session, assesses an individual's current functional capabilities when engaging in various activities that involve physical exertion. Items include Can you walk a block or two on level ground? and Can you climb a flight of stairs or walk up a hill? Individual item responses are weighted based upon their metabolic cost, and subsequently summed to yield a total score. A higher score indicates better functional capability. The DASI is a continuous measure and thus, was left continuous in our model and was not categorized. Because the DASI is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected scores of 40, 50, and 60 as values to report the model-based | Baseline, 8 and 16 weeks | 
| Change (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form | Change (per day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form, specifically at scores of 150, 350, and 850. This 7-item measure, administered at the screening and study randomization sessions, evaluates engagement in vigorous, moderate, and light (e.g., walking) activity in the prior 7 days. Higher scores on the IPAQ indicate higher activity levels. The IPAQ is a continuous measure and thus, was left continuous in our model and was not categorized. Because the IPAQ is a continuous measure, we assumed a continuous linear change in the effect per unit change. For purposes of presenting the results, we selected scores of 150, 350, and 850 as values to report the model-based slopes. We reported those values based on approximate 25th, 50th, 75th percentiles among baseline IPAQ scores among H3M participants. | Baseline, 8 and 16 weeks | 
| Change (Per Day) in Average Daily Steps Stratified by Education | Change (per day) in Average Daily Steps Stratified by education. Education was self-reported in the demographics questionnaire. Education is reported as: less than 4-year college, 4-year college, and more than 4-year college | Baseline, 8 and 16 weeks | 
| Change (Per Day) in Average Daily Steps Stratified by Employment | Change (per day) in Average Daily Steps Stratified by the employment. Employment was self-reported in the demographics questionnaire. Employment is reported as employed, unemployed, and other. | Baseline, 8 and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Online Therapy, Fitbit, Depression, Cardiovascular Disease