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Healthy Hearts Healthy Minds

Healthy Hearts Healthy Minds: A PPRN Demonstration Pragmatic Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03373110
Acronym
H3M
Enrollment
506
Registered
2017-12-14
Start date
2018-02-13
Completion date
2019-03-08
Last updated
2022-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Depression

Keywords

Online Therapy, Fitbit, Depression, Cardiovascular Disease

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.

Interventions

BEHAVIORALOnline Mindfulness Based Cognitive Therapy

see arm description

see arm description

BEHAVIORALFitbit Alone

see arm description

Sponsors

University of California, San Francisco
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change (Per Day) in Average Daily Steps From BaselineBaseline, 8 weeks, and 16 weeksParticipants 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.

Secondary

MeasureTime frameDescription
Change (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)Baseline, 8 and 16 weeksChange 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.
Change (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)Baseline, 8 and 16 weeksChange 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.
Change (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)Baseline, 8 and 16 weeksChange 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.
Change (Per Day) in Average Daily Steps Stratified by AgeBaseline, 8 and 16 weeksChange 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.
Change (Per Day) in Average Daily Steps Stratified by SexBaseline, 8 and 16 weeksChange per day in average daily steps stratified by sex. Participants self-reported male or female on the demographics form.
Change (Per Day) in Average Daily Steps Stratified by AnxietyBaseline, 8 and 16 weeksChange per day in average daily steps stratified by anxiety. Comorbid anxiety was self-reported in the psychiatric history questionnaire.
Change (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)Baseline, 8 and 16 weeksChange 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.
Change (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)Baseline, 8 and 16 weeksChange 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.
Change (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)Baseline, 8 and 16 weeksChange (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
Change (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short FormBaseline, 8 and 16 weeksChange (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.
Change (Per Day) in Average Daily Steps Stratified by EducationBaseline, 8 and 16 weeksChange (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
Change (Per Day) in Average Daily Steps Stratified by EmploymentBaseline, 8 and 16 weeksChange (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.
Change (Per Day) in Average Daily Steps Stratified by SmokingBaseline, 8 and 16 weeksChange per day in average daily steps stratified by smoking status. Smoker or non-smoker was self-reported on the psychiatric history questionnaire.

Countries

United States

Participant flow

Pre-assignment details

491 participants were consented, 361 participants met eligibility criteria and were randomized to study intervention arms. 21 participants withdrew their consent and, thus, data from these 21 participants are not used or presented. Of the 340 randomized participants, 314 participants had usable Fitbit data. Therefore, 314 participants were included in all analyses (i.e., primary and secondary outcomes). We have added adverse event data on all randomized participants (i.e., 361 participants).

Participants by arm

ArmCount
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. Online Mindfulness Based Cognitive Therapy: see arm description
133
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. Online Cognitive Behavioral Therapy: see arm description
137
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. Fitbit Alone: see arm description
70
Total340

Baseline characteristics

CharacteristicOnline Cognitive Behavioral Therapy +FitbitTotalFitbit AloneOnline Mindfulness Based Cognitive Therapy +Fitbit
Age, Continuous43.9 years
STANDARD_DEVIATION 11.2
43.3 years
STANDARD_DEVIATION 11.3
43.4 years
STANDARD_DEVIATION 10.8
42.5 years
STANDARD_DEVIATION 11.6
Bipolar Disorder21 Participants51 Participants12 Participants18 Participants
Education
4-year college graduate
37 Participants82 Participants14 Participants31 Participants
Education
High school graduate/GED
9 Participants25 Participants8 Participants8 Participants
Education
Missing/unknown
1 Participants2 Participants0 Participants1 Participants
Education
More than 4-year college
39 Participants115 Participants27 Participants49 Participants
Education
Some college/2-year degree
50 Participants114 Participants21 Participants43 Participants
Education
Some high school
1 Participants2 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants26 Participants5 Participants9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
124 Participants310 Participants64 Participants122 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants4 Participants1 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
10 Participants23 Participants7 Participants6 Participants
Race (NIH/OMB)
More than one race
10 Participants24 Participants3 Participants11 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants12 Participants2 Participants5 Participants
Race (NIH/OMB)
White
112 Participants281 Participants58 Participants111 Participants
Sex: Female, Male
Female
110 Participants279 Participants61 Participants108 Participants
Sex: Female, Male
Male
27 Participants61 Participants9 Participants25 Participants
Sexual Orientation
Asexual
2 Participants7 Participants0 Participants5 Participants
Sexual Orientation
Bisexual
11 Participants22 Participants6 Participants5 Participants
Sexual Orientation
Gay
2 Participants9 Participants2 Participants5 Participants
Sexual Orientation
Lesbian
1 Participants10 Participants5 Participants4 Participants
Sexual Orientation
Missing/Unknown
2 Participants7 Participants1 Participants4 Participants
Sexual Orientation
Other
1 Participants10 Participants2 Participants7 Participants
Sexual Orientation
Straight
118 Participants275 Participants54 Participants103 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1440 / 1450 / 72
other
Total, other adverse events
53 / 14445 / 14530 / 72
serious
Total, serious adverse events
0 / 1441 / 1450 / 72

Outcome results

Primary

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.

Time frame: Baseline, 8 weeks, and 16 weeks

ArmMeasureGroupValue (MEAN)
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps From Baseline8 weeks2.8 Change (per day) in Average Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps From Baseline16 weeks-1.2 Change (per day) in Average Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps From Baseline8 weeks2.9 Change (per day) in Average Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps From Baseline16 weeks-1.8 Change (per day) in Average Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps From Baseline8 weeks-8.2 Change (per day) in Average Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps From Baseline16 weeks-2.6 Change (per day) in Average Daily Steps
Comparison: We used linear mixed effects models fit via maximum likelihood to examine the effect of the interventions on daily steps. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction. We used separate models to assess the intervention effects across the 8-week intervention period as well as the complete 16-week follow-up period.p-value: 0.973Mixed Models Analysis
Comparison: We used linear mixed effects models to examine the effect of the interventions on average daily steps at 8 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.p-value: 0.005Mixed Models Analysis
Comparison: We used linear mixed effects models to examine the effect of the interventions on average daily steps at 8 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.p-value: 0.004Mixed Models Analysis
Comparison: We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.p-value: 0.627Mixed Models Analysis
Comparison: We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.p-value: 0.359Mixed Models Analysis
Comparison: We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.p-value: 0.597Mixed Models Analysis
Secondary

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.

Time frame: Baseline, 8 and 16 weeks

ArmMeasureGroupValue (MEAN)
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Age8 weeks: age 35-2.8 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Age8 weeks: age 45.6 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Age8 weeks: age 5510.7 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Age16 weeks: age 35-2.8 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Age16 weeks: age 45-1.8 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Age16 weeks: age 551.5 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Age16 weeks: age 55-.9 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Age8 weeks: age 35-2.2 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Age16 weeks: age 35-2.6 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Age16 weeks: age 45-1.8 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Age8 weeks: age 453.3 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Age8 weeks: age 558.7 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Age8 weeks: age 45-9.4 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Age8 weeks: age 55-16.4 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Age16 weeks: age 55-3.4 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Age16 weeks: age 35-2.0 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Age8 weeks: age 35-2.5 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Age16 weeks: age 45-2.7 Change (per day) in Avg Daily Steps
Secondary

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.

Time frame: Baseline, 8 and 16 weeks

ArmMeasureGroupValue (MEAN)
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Anxiety8 weeks: Anxiety-1.5 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Anxiety8 weeks: No anxiety9.6 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Anxiety16 weeks: Anxiety-1.8 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Anxiety16 weeks: No anxiety.7 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Anxiety16 weeks: No anxiety.7 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Anxiety8 weeks: Anxiety4.5 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Anxiety16 weeks: Anxiety-3.6 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Anxiety8 weeks: No anxiety.7 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Anxiety16 weeks: No anxiety-7.7 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Anxiety8 weeks: No anxiety-13.8 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Anxiety16 weeks: Anxiety-.2 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Anxiety8 weeks: Anxiety-5.7 Change (per day) in Avg Daily Steps
Secondary

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

Time frame: Baseline, 8 and 16 weeks

ArmMeasureGroupValue (MEAN)
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Education8 weeks: less than 4 year college-2.3 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Education8 weeks: 4-year college2.1 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Education8 weeks: more than 4-year college8.2 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Education16 weeks: less than 4-year college-.1 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Education16 weeks: 4-year college-4.9 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Education16 weeks: more than 4-year college.1 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Education16 weeks: more than 4-year college-.9 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Education8 weeks: less than 4 year college-1.8 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Education16 weeks: less than 4-year college-1.8 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Education16 weeks: 4-year college-2.4 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Education8 weeks: 4-year college5.5 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Education8 weeks: more than 4-year college7.4 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Education8 weeks: 4-year college9.3 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Education8 weeks: more than 4-year college-15.9 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Education16 weeks: more than 4-year college-.6 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Education16 weeks: less than 4-year college-3.9 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Education8 weeks: less than 4 year college-7.2 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Education16 weeks: 4-year college-4.2 Change (per day) in Avg Daily Steps
Secondary

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.

Time frame: Baseline, 8 and 16 weeks

ArmMeasureGroupValue (MEAN)
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Employment8 week: employed6.1 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Employment8 week: unemployed-15.8 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Employment8 week: other3.2 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Employment16 week: employed.8 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Employment16 week: unemployed-14.9 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Employment16 week: other1.3 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Employment16 week: other-7.6 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Employment8 week: employed2.4 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Employment16 week: employed-.6 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Employment16 week: unemployed.5 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Employment8 week: unemployed11.7 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Employment8 week: other-1.0 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Employment8 week: unemployed2.8 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Employment8 week: other-11.5 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Employment16 week: other-4.4 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Employment16 week: employed-2.1 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Employment8 week: employed-8.4 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Employment16 week: unemployed-2.6 Change (per day) in Avg Daily Steps
Secondary

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.

Time frame: Baseline, 8 and 16 weeks

ArmMeasureGroupValue (MEAN)
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)8 week: SEE score 301.2 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)8 week: SEE score 453.3 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)8 week: SEE score 554.7 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)16 weeks: SEE score 30-1.0 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)16 weeks: SEE score 45-1.3 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)16 weeks: SEE score 55-1.4 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)16 weeks: SEE score 55-2.5 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)8 week: SEE score 304.5 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)16 weeks: SEE score 30-.8 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)16 weeks: SEE score 45-1.9 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)8 week: SEE score 452.8 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)8 week: SEE score 551.8 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)8 week: SEE score 45-9.0 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)8 week: SEE score 55-11.0 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)16 weeks: SEE score 55-5.4 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)16 weeks: SEE score 30-.3 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)8 week: SEE score 30-6.0 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)16 weeks: SEE score 45-3.4 Change (per day) in Avg Daily Steps
Secondary

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.

Time frame: Baseline, 8 and 16 weeks

ArmMeasureGroupValue (MEAN)
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Sex8 weeks: Male-1.9 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Sex8 weeks: Female3.8 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Sex16 weeks: Male0.4 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Sex16 weeks: Female-1.5 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Sex16 weeks: Female-1.3 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Sex8 weeks: Male-10.7 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Sex16 weeks: Male-4.4 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Sex8 weeks: Female5.8 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Sex16 weeks: Female-1.7 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Sex8 weeks: Female-8.8 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Sex16 weeks: Male-12.0 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Sex8 weeks: Male-3.2 Change (per day) in Avg Daily Steps
Secondary

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.

Time frame: Baseline, 8 and 16 weeks

ArmMeasureGroupValue (MEAN)
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Smoking8 weeks: Smoker-18.2 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Smoking8 weeks: Non-smoker3.6 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Smoking16 weeks: Smoker-7.2 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Smoking16 weeks: Non-smoker-1.0 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Smoking16 weeks: Non-smoker-1.2 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Smoking8 weeks: Smoker-17.3 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Smoking16 weeks: Smoker-12.5 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by Smoking8 weeks: Non-smoker4.1 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Smoking16 weeks: Non-smoker-2.6 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Smoking8 weeks: Non-smoker-6.4 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Smoking16 weeks: Smoker-2.6 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by Smoking8 weeks: Smoker-20.2 Change (per day) in Avg Daily Steps
Secondary

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.

Time frame: Baseline, 8 and 16 weeks

ArmMeasureGroupValue (MEAN)
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)8 week: ASRM score 02.6 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)8 week: ASRM score 12.7 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)8 week: ASRM score 32.9 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)16 week: ASRM score 00.3 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)16 week: ASRM score 1-.5 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)16 week: ASRM score 3-2.2 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)16 week: ASRM score 3-2.3 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)8 week: ASRM score 03.1 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)16 week: ASRM score 0-.6 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)16 week: ASRM score 1-1.2 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)8 week: ASRM score 13.0 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)8 week: ASRM score 32.8 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)8 week: ASRM score 1-9.9 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)8 week: ASRM score 3-6.6 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)16 week: ASRM score 3-1.4 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)16 week: ASRM score 0-5.1 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)8 week: ASRM score 0-11.6 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)16 week: ASRM score 1-3.9 Change (per day) in Avg Daily Steps
Secondary

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

Time frame: Baseline, 8 and 16 weeks

ArmMeasureGroupValue (MEAN)
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)8 week: DASI score 403.3 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)8 week: DASI score 502.6 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)8 week: DASI score 602.0 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)16 week: DASI score 40-2.0 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)16 week: DASI score 50-1.0 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)16 week: DASI score 600.0 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)16 week: DASI score 60-1.6 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)8 week: DASI score 404.5 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)16 week: DASI score 40-1.9 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)16 week: DASI score 50-1.8 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)8 week: DASI score 502.4 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)8 week: DASI score 60.3 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)8 week: DASI score 50-8.4 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)8 week: DASI score 60-9.2 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)16 week: DASI score 60-.6 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)16 week: DASI score 40-3.5 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)8 week: DASI score 40-7.6 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)16 week: DASI score 50-2.0 Change (per day) in Avg Daily Steps
Secondary

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.

Time frame: Baseline, 8 and 16 weeks

ArmMeasureGroupValue (MEAN)
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form8 week: IPAQ score 1501.1 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form8 week: IPAQ score 3502.0 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form8 week: IPAQ score 8504.2 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form16 week: IPAQ score 150-3.1 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form16 week: IPAQ score 350-2.8 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form16 week: IPAQ score 850-2.2 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form16 week: IPAQ score 850-2.4 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form8 week: IPAQ score 1503.0 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form16 week: IPAQ score 150-1.6 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form16 week: IPAQ score 350-1.8 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form8 week: IPAQ score 3502.9 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form8 week: IPAQ score 8502.7 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form8 week: IPAQ score 350-9.8 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form8 week: IPAQ score 850-12.5 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form16 week: IPAQ score 850-3.6 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form16 week: IPAQ score 150-1.7 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form8 week: IPAQ score 150-8.7 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form16 week: IPAQ score 350-2.2 Change (per day) in Avg Daily Steps
Secondary

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.

Time frame: Baseline, 8 and 16 weeks

ArmMeasureGroupValue (MEAN)
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)8 weeks: PHQ-9 Score of 56.3 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)8 weeks: PHQ-9 Score of 103.0 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)8 weeks: PHQ-9 Score of 15-.4 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)16 weeks: PHQ-9 Score of 5-1.1 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)16 weeks: PHQ-9 Score of 10-1.2 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)16 weeks: PHQ-9 Score of 15-1.3 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)16 weeks: PHQ-9 Score of 15-4.1 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)8 weeks: PHQ-9 Score of 55.7 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)16 weeks: PHQ-9 Score of 50.9 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)16 weeks: PHQ-9 Score of 10-1.6 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)8 weeks: PHQ-9 Score of 103.2 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)8 weeks: PHQ-9 Score of 15.7 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)8 weeks: PHQ-9 Score of 10-8.3 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)8 weeks: PHQ-9 Score of 15-7.5 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)16 weeks: PHQ-9 Score of 15-2.9 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)16 weeks: PHQ-9 Score of 5-2.2 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)8 weeks: PHQ-9 Score of 5-9.1 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)16 weeks: PHQ-9 Score of 10-2.6 Change (per day) in Avg Daily Steps
Secondary

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.

Time frame: Baseline, 8 and 16 weeks

ArmMeasureGroupValue (MEAN)
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)8 weeks: PSS score 158.2 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)8 weeks: PSS score 203.9 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)8 weeks: PSS score 25-.5 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)16 weeks: PSS score 15-.8 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)16 weeks: PSS score 20-1.1 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)16 weeks: PSS score 25-1.5 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)16 weeks: PSS score 25-2.3 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)8 weeks: PSS score 156.3 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)16 weeks: PSS score 15-0.6 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)16 weeks: PSS score 20-1.5 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)8 weeks: PSS score 204.0 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)8 weeks: PSS score 251.6 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)8 weeks: PSS score 20-7.2 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)8 weeks: PSS score 25-9.5 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)16 weeks: PSS score 25-2.7 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)16 weeks: PSS score 15-2.3 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)8 weeks: PSS score 15-4.8 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)16 weeks: PSS score 20-2.5 Change (per day) in Avg Daily Steps
Secondary

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.

Time frame: Baseline, 8 and 16 weeks

ArmMeasureGroupValue (MEAN)
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)8 weeks: WHO-5 score 15-1.4 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)8 weeks: WHO-5 score 302.2 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)8 weeks: WHO-5 score 455.8 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)16 weeks: WHO-5 score 15-2.0 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)16 weeks: WHO-5 score 30-1.4 Change (per day) in Avg Daily Steps
Online Mindfulness Based Cognitive Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)16 weeks: WHO-5 score 45-.7 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)16 weeks: WHO-5 score 45-.6 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)8 weeks: WHO-5 score 15-1.3 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)16 weeks: WHO-5 score 15-3.5 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)16 weeks: WHO-5 score 30-2.0 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)8 weeks: WHO-5 score 302.5 Change (per day) in Avg Daily Steps
Online Cognitive Behavioral Therapy +FitbitChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)8 weeks: WHO-5 score 456.3 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)8 weeks: WHO-5 score 30-8.0 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)8 weeks: WHO-5 score 45-5.9 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)16 weeks: WHO-5 score 45-1.2 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)16 weeks: WHO-5 score 15-3.9 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)8 weeks: WHO-5 score 15-10.2 Change (per day) in Avg Daily Steps
Fitbit AloneChange (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)16 weeks: WHO-5 score 30-2.5 Change (per day) in Avg Daily Steps

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026