Healthy Hearts Healthy Minds
H3M
1 other identifier
interventional
506
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Feb 2018
Shorter than P25 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2017
CompletedFirst Posted
Study publicly available on registry
December 14, 2017
CompletedStudy Start
First participant enrolled
February 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2019
CompletedResults Posted
Study results publicly available
April 29, 2021
CompletedFebruary 2, 2022
January 1, 2022
1.1 years
August 11, 2017
November 30, 2020
January 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
Change (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)
Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)
Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)
Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)
Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by Age
Baseline, 8 and 16 weeks
- +8 more secondary outcomes
Study Arms (3)
Online Mindfulness Based Cognitive Therapy +Fitbit
EXPERIMENTALA 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.
Online Cognitive Behavioral Therapy +Fitbit
EXPERIMENTAL1)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.
Fitbit Alone
ACTIVE COMPARATORParticipants 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.
Interventions
see arm description
see arm description
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dauten Family Center for Bipolar Treatment Innovation
Boston, Massachusetts, 02114, United States
Related Publications (1)
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.
PMID: 36525851DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
(1) Our sample was disproportionately white (83%), female (82%), and highly educated (i.e., 92% had a college education or more); (2) study data (e.g., medical history, psychiatric diagnoses, mood symptoms, overall wellness) were self-report; and (3) we did not provide any personal contact with study staff for clarifying study procedures, supporting the intervention material, and/or troubleshooting technical issues with the Fitbit or online platform unless participants proactively emailed us.
Results Point of Contact
- Title
- Dr. Andrew Nierenberg
- Organization
- Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Dauten Family Center for Bipolar Treatment Innovation
Study Record Dates
First Submitted
August 11, 2017
First Posted
December 14, 2017
Study Start
February 13, 2018
Primary Completion
March 8, 2019
Study Completion
March 8, 2019
Last Updated
February 2, 2022
Results First Posted
April 29, 2021
Record last verified: 2022-01