Clinical trial NCT03373110: Healthy Hearts Healthy Minds
Official title: Healthy Hearts Healthy Minds: A PPRN Demonstration Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Depression
Keywords: Online Therapy
Fitbit
Depression
Cardiovascular Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2017-12-14
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change (Per Day) in Average Daily Steps From Baseline
timeFrame: Baseline, 8 weeks, and 16 weeks
Secondary outcomes:
measure: Change (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 8 and 16 weeks
measure: Change (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)
timeFrame: Baseline, 8 and 16 weeks
measure: Change (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)
timeFrame: Baseline, 8 and 16 weeks
measure: Change (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)
timeFrame: Baseline, 8 and 16 weeks
measure: Change (Per Day) in Average Daily Steps Stratified by Age
timeFrame: Baseline, 8 and 16 weeks
measure: Change (Per Day) in Average Daily Steps Stratified by Sex
timeFrame: Baseline, 8 and 16 weeks
measure: Change (Per Day) in Average Daily Steps Stratified by Anxiety
timeFrame: Baseline, 8 and 16 weeks
measure: Change (Per Day) in Average Daily Steps Stratified by Smoking
timeFrame: Baseline, 8 and 16 weeks
measure: Change (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)
timeFrame: Baseline, 8 and 16 weeks
measure: Change (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)
timeFrame: Baseline, 8 and 16 weeks
measure: Change (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form
timeFrame: Baseline, 8 and 16 weeks
measure: Change (Per Day) in Average Daily Steps Stratified by Education
timeFrame: Baseline, 8 and 16 weeks
measure: Change (Per Day) in Average Daily Steps Stratified by Employment
timeFrame: Baseline, 8 and 16 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dauten Family Center for Bipolar Treatment Innovation
state: Massachusetts
Study officials:
References: