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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04139005
Other study ID # 2019-0893
Secondary ID A538900SMPH/PSYC
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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