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

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

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.

Study Overview

• Status: Completed
• Conditions: Well-being
• Intervention / Treatment: Behavioral: Awareness; Behavioral: Connection; Behavioral: Insight

• Study Type: Interventional
• Enrollment (Actual): 383
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53703
      • Center for Healthy Minds

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Awareness-Connection	Behavioral: Awareness; The program foundation targets attention and awareness skills that are integral to many conceptions of mindfulness.; Other Names: Healthy Minds Program; Behavioral: Connection; 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.; Other Names: Healthy Minds Program
Experimental: Awareness-Insight	Behavioral: Awareness; The program foundation targets attention and awareness skills that are integral to many conceptions of mindfulness.; Other Names: Healthy Minds Program; Behavioral: Insight; The Insight module targets skills underlying dynamic self-inquiry and experiential self-knowledge.; Other Names: Healthy Minds Program
No Intervention: Wait list

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Simon Goldberg, PhD, University of Wisconsin, Madison; Principal Investigator: Melissa Rosenkranz, PhD, University of Wisconsin, Madison

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): January 8, 2021
• Study Completion (Actual): January 8, 2021

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019-0893; A538900 (Other Identifier: UW Madison); SMPH/PSYCHIATRY/PSYCHIATRY (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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.

• IPD Sharing Time Frame: Data may be shared following analysis and publication or upon request.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No