Well-being and the Healthy Minds App Pilot (WHAP) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 383
- 试验地点
- 2
- 主要终点
- Change in Dispositional empathy as assessed by Interpersonal Reactivity Scale
研究概览
简要总结
There is no single definition of well-being, but consensus exists that positive functioning beyond the absence of detrimental mental health symptoms is central. Building on related "eudaimonic" frameworks of psychological flourishing that identify qualities like environmental mastery, positive relations with others, and personal growth, this study targets brain-based skills that underlie the active cultivation of such qualities (e.g., regulating attention, empathic care, mental flexibility), and thus offers straightforward hypotheses about mechanisms of change.
The Healthy Minds Program (HMP) is designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of high-quality guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). HMP practices address 4 constituents of well-being: awareness, connection, insight, and purpose. This pilot focuses on awareness, connection, and insight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Between the age of 18-65
排除标准
- •Individuals under 18 or over 65
- •Significant meditation experience (as defined below):
- •Meditation retreat experience (meditation retreat or yoga/body practice retreat with significant meditation component).
- •Regular meditation practice weekly for over 1 year OR daily practice within the previous 6 months.
- •Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course.
结局指标
主要结局
Change in Dispositional empathy as assessed by Interpersonal Reactivity Scale
时间窗: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
Self-reported thoughts and feelings related to empathy. Twenty-eight items are scored on a scale of A-E (A = does not describe me well, E = describes me very well).
Change in Compassion as assessed by Compassionate Love Scale
时间窗: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
Self-reported feelings of compassion for close others and humanity. Twenty-one items are scored on a scale of 1-7 (1 = not true at all of me, 7 = very true of me).
Change in Self-Reflection and Insight Scale score
时间窗: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
Self-reported thoughts of introspection and self-understanding. Twenty items are scored on a scale of 1-6 (1 = strongly disagree, 6 = strongly agree).
Change in Depression symptoms as assessed by PROMIS Depression score
时间窗: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
Self-reported experience of depression symptoms over the past 7 days. Eight items are scored on a scale of 1-5 (1 = never experience, 5 = always experience).
Change in Anxiety symptoms as assessed by PROMIS Anxiety score
时间窗: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
Self-reported experience of anxiety symptoms over the past 7 days. Eight items are scored on a scale of 1-5 (1 = never experience, 5 = always experience).
Change in Perceived Stress Scale
时间窗: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
Self-reported stressful experiences over the past month. Fourteen items are scored on a scale of 0-4 (0 = never experience, 4 = very often experience).
Change in the Social Connectedness Scale score
时间窗: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
Self-reported feelings related to social connection. Twenty items are scored on a scale of 1-6 (1 = strongly disagree, 6 = strongly agree).
Change in repetitive negative thinking as assessed by Perseverative Thinking Questionnaire score
时间窗: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
Self-reported experiences with negative thoughts. Fifteen items are scored on a scale of 0-4 (0 = never, 4 = almost always).
Change in the Defusion as assessed by Drexel Defusion Scale
时间窗: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
Self-reported distancing from internal experiences during difficult hypothetical situations. Ten items are scored on a scale of 0-5 (0 = not at all, 5 = very much).
次要结局
- App Usage as assessed by number of logins(up to 9 month follow-up)
- App Usage as assessed by minutes of practice each day(up to 9 month follow-up)
- Change in the Mindfulness (Five Factor Mindfulness Questionnaire)(Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up)