Cardiovascular DiseasesH3MNCT03373110
Healthy Hearts Healthy Minds
A study testing Online Mindfulness Based Cognitive Therapy, Online Cognitive Behavioral Therapy and Fitbit Alone in people with Cardiovascular Diseases and Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiovascular Diseases, Depression
- What is being tested?
- Online Mindfulness Based Cognitive Therapy, Online Cognitive Behavioral Therapy and Fitbit Alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2018to 8 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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"
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dauten Family Center for Bipolar Treatment Innovation
Boston, Massachusetts, 02114
About this study
Official title: Healthy Hearts Healthy Minds: A PPRN Demonstration Pragmatic Trial
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.
Read the 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
- Being tested
- Online Mindfulness Based Cognitive Therapy, Online Cognitive Behavioral Therapy, Fitbit Alone
- Keywords
- Online Therapy, Fitbit, Depression, Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Mindfulness Based Cognitive TherapyBehavioural
see arm description
Online Cognitive Behavioral TherapyBehavioural
see arm description
Fitbit AloneBehavioural
see arm description
| Study group | Role | What they receive |
|---|---|---|
| Online Mindfulness Based Cognitive Therapy +Fitbit | Experimental | 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. Receives: Behavioral: Online Mindfulness Based Cognitive Therapy |
| Online Cognitive Behavioral Therapy +Fitbit | Experimental | 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. Receives: Behavioral: Online Cognitive Behavioral Therapy |
| Fitbit Alone | Active comparator | 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. Receives: Behavioral: Fitbit Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks, and 16 weeks
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, 8 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start13 Feb 2018
- Primary completion8 Mar 2019
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Andrew A. Nierenberg, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373110
- Sponsor's protocol ID
- 2017P001758
- Acronym
- H3M
- Status last verified
- Jan 2022
- First submitted
- 11 Aug 2017
- Last updated
- 2 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36525851
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Hearts Healthy Minds: A PPRN Demonstration Pragmatic Trial
- ClinicalTrials.gov ID
- NCT03373110
- Acronym / sponsor ID
- H3M / 2017P001758
- Conditions
- Cardiovascular Diseases, Depression
- Keywords
- Online Therapy, Fitbit, Depression, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Posted 29 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Online Mindfulness Based Cognitive Therapy +Fitbit | Experimental | Behavioral: Online Mindfulness Based Cognitive TherapyA 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 | Experimental | Behavioral: Online Cognitive Behavioral Therapy1)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 comparator | Behavioral: Fitbit AloneParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Mindfulness Based Cognitive Therapysee arm description | Behavioural | Online Mindfulness Based Cognitive Therapy +Fitbit |
| Online Cognitive Behavioral Therapysee arm description | Behavioural | Online Cognitive Behavioral Therapy +Fitbit |
| Fitbit Alonesee arm description | Behavioural | Fitbit Alone |
Primary outcome
Change (Per Day) in Average Daily Steps From Baseline
Time frame: Baseline, 8 weeks, and 16 weeks
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.
13 secondary outcomes
Change (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)
Time frame: Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)
Time frame: Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)
Time frame: Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by Age
Time frame: Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by Sex
Time frame: Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by Anxiety
Time frame: Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by Smoking
Time frame: Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)
Time frame: Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)
Time frame: Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form
Time frame: Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by Education
Time frame: Baseline, 8 and 16 weeks
Change (Per Day) in Average Daily Steps Stratified by Employment
Time frame: Baseline, 8 and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36525851Sylvia 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.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiovascular Diseases
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Systematic Ambulatory ECG Monitoring Following TAVI
Aortic Stenosis, Conduction Disturbances
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Active, not recruiting
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Mindfulness Based Cognitive Therapy, Online Cognitive Behavioral Therapy and Fitbit Alone in people with Cardiovascular Diseases and Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (Per Day) in Average Daily Steps From Baseline (time frame: Baseline, 8 weeks, and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.