N/A
N=340
Healthy Hearts Healthy Minds
Cardiovascular Diseases · Depression
Bottom Line
View on ClinicalTrials.gov: NCT03373110 ↗Enrolled (actual)
340
Serious AEs
0.3%
Results posted
Apr 2021
Primary outcome: Primary: Change (Per Day) in Average Daily Steps From Baseline — 2.8; 2.9; -8.2; -1.2 Change (per day) in Average Daily Steps — p=0.973
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Online Mindfulness Based Cognitive Therapy (Behavioral); Online Cognitive Behavioral Therapy (Behavioral); Fitbit Alone (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change (Per Day) in Average Daily Steps From Baseline |
2.8; 2.9; -8.2; -1.2; -1.8; -2.6 | 0.973 |
| SECONDARY Change (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9) |
6.3; 5.7; -9.1; 3.0; 3.2; -8.3 | — |
| SECONDARY Change (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM) |
2.6; 3.1; -11.6; 2.7; 3.0; -9.9 | — |
| SECONDARY Change (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5) |
-1.4; -1.3; -10.2; 2.2; 2.5; -8.0 | — |
| SECONDARY Change (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS) |
8.2; 6.3; -4.8; 3.9; 4.0; -7.2 | — |
| SECONDARY Change (Per Day) in Average Daily Steps Stratified by Age |
-2.8; -2.2; -2.5; .6; 3.3; -9.4 | — |
| SECONDARY Change (Per Day) in Average Daily Steps Stratified by Sex |
-1.9; -10.7; -3.2; 3.8; 5.8; -8.8 | — |
| SECONDARY Change (Per Day) in Average Daily Steps Stratified by Anxiety |
-1.5; 4.5; -5.7; 9.6; .7; -13.8 | — |
| SECONDARY Change (Per Day) in Average Daily Steps Stratified by Smoking |
-18.2; -17.3; -20.2; 3.6; 4.1; -6.4 | — |
| SECONDARY Change (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE) |
1.2; 4.5; -6.0; 3.3; 2.8; -9.0 | — |
| SECONDARY Change (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI) |
3.3; 4.5; -7.6; 2.6; 2.4; -8.4 | — |
| SECONDARY Change (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form |
1.1; 3.0; -8.7; 2.0; 2.9; -9.8 | — |
| SECONDARY Change (Per Day) in Average Daily Steps Stratified by Education |
-2.3; -1.8; -7.2; 2.1; 5.5; 9.3 | — |
| SECONDARY Change (Per Day) in Average Daily Steps Stratified by Employment |
6.1; 2.4; -8.4; -15.8; 11.7; 2.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Ability to give informed consent
- Fluent in English
- Between the ages of 18-65
- Lives in the United States
- Self-report of having experienced depression as assessed by the Mini International Neuropsychiatric Interview (MINI)
- Self report an elevated risk for or of having cardiovascular disease ( >150 minutes of physical activity a week)
- Registered a personal account with Fitbit prior to enrollment in the study
Exclusion Criteria
- Unwilling/unable to comply with study procedures
- Pregnant
- Responds to item 9 (Suicidal ideation) on the PHQ-9 with a 3 or higher (i.e., "Thoughts that you would be better off dead or of hurting yourself in some way on more than half the days")
- Contraindications to exercise or diet interventions as assessed by the DASI
- Already uses a Fitbit device or other activity monitor
- Suffers from repeated episodes of "blacking out" or "fainting"
- Survived a cardiac arrest or sudden death
- Has recurrent chest discomfort with activity that goes away within 10 minutes of rest or with nitroglycerin
- Has heart failure
- Has been hospitalized recently (within past 6 weeks) for a cardiovascular problem
Data sourced from ClinicalTrials.gov (NCT03373110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.