Well-being and the HM App Pilot (WHAP) Study

Study Overview
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Brief Summary
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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.

Official Title
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Well-being and the Healthy Minds App Pilot (WHAP) Study

Conditions
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Well-being

Intervention / Treatment
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* Behavioral: Awareness
* Behavioral: Connection
* Behavioral: Insight


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the age of 18-65 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Awareness-Connection<br> | Behavioral: Awareness<br>* The program foundation targets attention and awareness skills that are integral to many conceptions of mindfulness.<br>* Other names: Healthy Minds Program;Behavioral: Connection<br>* The Connection module targets skills underlying social connection, which refers to the sense of having close and positively experienced relationships with others in the social world.<br>* Other names: Healthy Minds Program;|
| Experimental: Awareness-Insight<br> | Behavioral: Awareness<br>* The program foundation targets attention and awareness skills that are integral to many conceptions of mindfulness.<br>* Other names: Healthy Minds Program;Behavioral: Insight<br>* The Insight module targets skills underlying dynamic self-inquiry and experiential self-knowledge.<br>* Other names: Healthy Minds Program;|
| No Intervention: Wait list<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression symptoms as assessed by PROMIS Depression score | 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). | Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up | 
| Change in Anxiety symptoms as assessed by PROMIS Anxiety score | 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). | Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up | 
| Change in Perceived Stress Scale | 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). | Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up | 
| Change in the Social Connectedness Scale score | Self-reported feelings related to social connection. Twenty items are scored on a scale of 1-6 (1 = strongly disagree, 6 = strongly agree). | Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up | 
| Change in Dispositional empathy as assessed by Interpersonal Reactivity Scale | 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). | Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up | 
| Change in Compassion as assessed by Compassionate Love Scale | 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). | Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up | 
| Change in Self-Reflection and Insight Scale score | Self-reported thoughts of introspection and self-understanding. Twenty items are scored on a scale of 1-6 (1 = strongly disagree, 6 = strongly agree). | Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up | 
| Change in repetitive negative thinking as assessed by Perseverative Thinking Questionnaire score | Self-reported experiences with negative thoughts. Fifteen items are scored on a scale of 0-4 (0 = never, 4 = almost always). | Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up | 
| Change in the Defusion as assessed by Drexel Defusion Scale | 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). | Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| App Usage as assessed by number of logins | Number of logins as tracked by the intervention app. | up to 9 month follow-up | 
| App Usage as assessed by minutes of practice each day | Minutes of practice as tracked by the intervention app. | up to 9 month follow-up | 
| Change in the Mindfulness (Five Factor Mindfulness Questionnaire) | Self-reported mindfulness during typical daily experiences. Thirty-nine items are scored on a scale of 1-5 (0 = never or very rarely true, 5 = very often or always true). | Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up |