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

Well-being Clinical Trial

— WHAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04139005
• Other study ID #: 2019-0893
• Secondary ID: A538900SMPH/PSYC
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: January 8, 2021

Study information

• Verified date: October 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: January 8, 2021
• Est. primary completion date: January 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Well-being

Intervention

Behavioral:
• Awareness
The program foundation targets attention and awareness skills that are integral to many conceptions of mindfulness.
• 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.
• Insight
The Insight module targets skills underlying dynamic self-inquiry and experiential self-knowledge.

Locations

Country	Name	City	State
United States	Center for Healthy Minds	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	App Usage as assessed by number of logins	Number of logins as tracked by the intervention app.	up to 9 month follow-up
Secondary	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
Secondary	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