Well-being and the HM App Pilot (WHAP) Study
WHAP
Well-being and the Healthy Minds App Pilot (WHAP) Study
3 other identifiers
interventional
383
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2019
CompletedFirst Submitted
Initial submission to the registry
October 23, 2019
CompletedFirst Posted
Study publicly available on registry
October 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2021
CompletedJanuary 26, 2021
October 1, 2020
1.2 years
October 23, 2019
January 22, 2021
Conditions
Outcome Measures
Primary Outcomes (9)
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 Outcomes (3)
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
Study Arms (3)
Awareness-Connection
EXPERIMENTALAwareness-Insight
EXPERIMENTALWait list
NO INTERVENTIONInterventions
The program foundation targets attention and awareness skills that are integral to many conceptions of mindfulness.
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.
The Insight module targets skills underlying dynamic self-inquiry and experiential self-knowledge.
Eligibility Criteria
You may qualify if:
- Between the age of 18-65
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Healthy Minds
Madison, Wisconsin, 53703, United States
Related Publications (1)
Goldberg SB, Imhoff-Smith T, Bolt DM, Wilson-Mendenhall CD, Dahl CJ, Davidson RJ, Rosenkranz MA. Testing the Efficacy of a Multicomponent, Self-Guided, Smartphone-Based Meditation App: Three-Armed Randomized Controlled Trial. JMIR Ment Health. 2020 Nov 27;7(11):e23825. doi: 10.2196/23825.
PMID: 33245288DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa Rosenkranz, PhD
University of Wisconsin, Madison
- PRINCIPAL INVESTIGATOR
Simon Goldberg, PhD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2019
First Posted
October 25, 2019
Study Start
October 15, 2019
Primary Completion
January 8, 2021
Study Completion
January 8, 2021
Last Updated
January 26, 2021
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data may be shared following analysis and publication or upon request.
Any collected data may be made anonymous and transmitted through shared folders, via email, by usb, or other avenues and made available upon request or shared publicly in an open science format. All identifiers (i.e., names, contact information, date of birth, visit dates) will be stripped to assure confidentiality of this data.