Skip to main content
OpenTrials
Completed

NCT Number: NCT04139005

Well-being and the HM 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Well-Being

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Healthy Minds

Madison, Wisconsin, 53703, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Awareness

Behavioral

The program foundation targets attention and awareness skills that are integral to many conceptions of mindfulness.

Other names: Healthy Minds Program

Connection

Behavioral

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

Insight

Behavioral

The Insight module targets skills underlying dynamic self-inquiry and experiential self-knowledge.

Other names: Healthy Minds Program

Primary outcomes

  1. Change in Depression symptoms as assessed by PROMIS Depression score

    Time frame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up

    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).

  2. Change in Anxiety symptoms as assessed by PROMIS Anxiety score

    Time frame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up

    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).

  3. Change in Perceived Stress Scale

    Time frame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up

    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).

  4. Change in the Social Connectedness Scale score

    Time frame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up

    Self-reported feelings related to social connection. Twenty items are scored on a scale of 1-6 (1 = strongly disagree, 6 = strongly agree).

  5. Change in Dispositional empathy as assessed by Interpersonal Reactivity Scale

    Time frame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up

    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).

  6. Change in Compassion as assessed by Compassionate Love Scale

    Time frame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up

    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).

  7. Change in Self-Reflection and Insight Scale score

    Time frame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up

    Self-reported thoughts of introspection and self-understanding. Twenty items are scored on a scale of 1-6 (1 = strongly disagree, 6 = strongly agree).

  8. Change in repetitive negative thinking as assessed by Perseverative Thinking Questionnaire score

    Time frame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up

    Self-reported experiences with negative thoughts. Fifteen items are scored on a scale of 0-4 (0 = never, 4 = almost always).

  9. Change in the Defusion as assessed by Drexel Defusion Scale

    Time frame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up

    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).

Secondary outcomes

  1. App Usage as assessed by number of logins

    Time frame: up to 9 month follow-up

    Number of logins as tracked by the intervention app.

  2. App Usage as assessed by minutes of practice each day

    Time frame: up to 9 month follow-up

    Minutes of practice as tracked by the intervention app.

  3. Change in the Mindfulness (Five Factor Mindfulness Questionnaire)

    Time frame: Baseline, 4-6 weeks, 10-12 weeks, 3 month follow-up, 6 month follow-up, 9 month follow-up

    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).

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Acronym: WHAP

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 25, 2019
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.