Clinical trial NCT04139005: Well-being and the HM App Pilot (WHAP) Study
Official title: Well-being and the Healthy Minds App Pilot (WHAP) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well-being
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Depression symptoms as assessed by PROMIS Depression score
timeFrame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
measure: Change in Anxiety symptoms as assessed by PROMIS Anxiety score
timeFrame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
measure: Change in Perceived Stress Scale
timeFrame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
measure: Change in the Social Connectedness Scale score
timeFrame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
measure: Change in Dispositional empathy as assessed by Interpersonal Reactivity Scale
timeFrame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
measure: Change in Compassion as assessed by Compassionate Love Scale
timeFrame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
measure: Change in Self-Reflection and Insight Scale score
timeFrame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
measure: Change in repetitive negative thinking as assessed by Perseverative Thinking Questionnaire score
timeFrame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
measure: Change in the Defusion as assessed by Drexel Defusion Scale
timeFrame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
Secondary outcomes:
measure: App Usage as assessed by number of logins
timeFrame: up to 9 month follow-up
measure: App Usage as assessed by minutes of practice each day
timeFrame: up to 9 month follow-up
measure: Change in the Mindfulness (Five Factor Mindfulness Questionnaire)
timeFrame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up
Other outcomes:
Locations:
city: Madison
country: United States
facility: Center for Healthy Minds
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Melissa Rosenkranz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Simon Goldberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.