Healthy Hearts Healthy Minds: A PPRN Demonstration Pragmatic Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 506
- 试验地点
- 2
- 主要终点
- Change (Per Day) in Average Daily Steps From Baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unwilling/unable to comply with study procedures
- •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
结局指标
主要结局
Change (Per Day) in Average Daily Steps From Baseline
时间窗: 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.
次要结局
- Change (Per Day) in Average Daily Steps Stratified by the Altman Self-Rating Mania Scale (ASRM)(Baseline, 8 and 16 weeks)
- Change (Per Day) in Average Daily Steps Stratified by the Well Being Index (WHO-5)(Baseline, 8 and 16 weeks)
- Change (Per Day) in Average Daily Steps Stratified by Anxiety(Baseline, 8 and 16 weeks)
- Change (Per Day) in Average Daily Steps Stratified by Smoking(Baseline, 8 and 16 weeks)
- Change (Per Day) in Average Daily Steps Stratified by Self-efficacy for Exercise (SEE)(Baseline, 8 and 16 weeks)
- Change (Per Day) in Average Daily Steps Stratified by the Patient Health Questionnaire (PHQ-9)(Baseline, 8 and 16 weeks)
- Change (Per Day) in Average Daily Steps Stratified by Age(Baseline, 8 and 16 weeks)
- Change (Per Day) in Average Daily Steps Stratified by Sex(Baseline, 8 and 16 weeks)
- Change (Per Day) in Average Daily Steps Stratified by the Perceived Stress Scale (PSS)(Baseline, 8 and 16 weeks)
- Change (Per Day) in Average Daily Steps Stratified by Education(Baseline, 8 and 16 weeks)
- Change (Per Day) in Average Daily Steps Stratified by Employment(Baseline, 8 and 16 weeks)
- Change (Per Day) in Average Daily Steps Stratified by the Duke Activity Status Index (DASI)(Baseline, 8 and 16 weeks)
- Change (Per Day) in Average Daily Steps Stratified by the International Physical Activity Questionnaire (IPAQ) - Short Form(Baseline, 8 and 16 weeks)
研究者
Andrew A. Nierenberg, MD
Director, Dauten Family Center for Bipolar Treatment Innovation
Massachusetts General Hospital