Healthy Hearts Healthy Minds

NCT ID: NCT03373110

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 506 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-13
• Study Completion Date: 2019-03-08

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.

Conditions

Cardiovascular Diseases; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Online Mindfulness Based Cognitive Therapy +Fitbit

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.

Group Type: EXPERIMENTAL

Online Mindfulness Based Cognitive Therapy

Intervention Type: BEHAVIORAL

see arm description

Online Cognitive Behavioral Therapy +Fitbit

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.

Group Type: EXPERIMENTAL

Online Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

see arm description

Fitbit Alone

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.

Group Type: ACTIVE_COMPARATOR

Fitbit Alone

Intervention Type: BEHAVIORAL

see arm description

Interventions

Online Mindfulness Based Cognitive Therapy

see arm description

Intervention Type: BEHAVIORAL

Online Cognitive Behavioral Therapy

see arm description

Intervention Type: BEHAVIORAL

Fitbit Alone

see arm description

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andrew A. Nierenberg, MD

Director, Dauten Family Center for Bipolar Treatment Innovation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dauten Family Center for Bipolar Treatment Innovation

Boston, Massachusetts, United States

Countries

United States

References

Sylvia LG, Gold AK, Rakhilin M, Amado S, Modrow MF, Albury EA, George N, Peters AT, Selvaggi CA, Horick N, Rabideau DJ, Dohse H, Tovey RE, Turner JA, Schopfer DW, Pletcher MJ, Katz D, Deckersbach T, Nierenberg AA. Healthy hearts healthy minds: A randomized trial of online interventions to improve physical activity. J Psychosom Res. 2023 Jan;164:111110. doi: 10.1016/j.jpsychores.2022.111110. Epub 2022 Dec 1.

Reference Type: DERIVED

PMID: 36525851 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017P001758

Identifier Type: -

Identifier Source: org_study_id