Healthy Minds Comparison Study

Not Applicable

Completed

• Conditions: Depression; Anxiety; Depression/Anxiety

• Registration Number: NCT06282523
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

The goal of this clinical trial is to understand the difference between two versions of the Healthy Minds application, a digital well-being program. The main question it aims to answer is the differences between versions of the Healthy Minds application and their effects on well-being.

Participants will complete an online four-week well-being program and complete surveys sent to their email. Participants can expect to participate in the study for four months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-28
• Study Start: 2024-06-19
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 532

Inclusion Criteria

• Age ≥18 years
• Elevated symptoms of depression and anxiety
• Proficient in English
• Access to a smartphone

Exclusion Criteria

• Prior experience with meditation generally
• Prior use of the Healthy Minds application
• History of psychosis or mania
• Alcohol and/or substance use disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety	Baseline, weeks 1, 2, 3, 4, and 3 months	Psychological distress will be computed as a composite of the PROMIS Depression and PROMIS Anxiety measures. We will use the computer adaptive version of both measures which have a mean of 50 and a standard deviation of 10. A composite will be computed by average across T-scores. T-scores range from 10 to 90 with higher scores indicating higher depression or anxiety.

Secondary Outcome Measures

Name	Time	Method
HMP App Utilization: Minutes	Study duration (4 weeks)	Minutes of meditation practice completed
Change in Digital Working Alliance Inventory (DWAI)	Baseline, weeks 1, 2, 3, 4, and 3 months	The DWAI is a 6-item questionnaire assessing participants' alliance with the HMP and HMRP app. It is scored on a 1- to 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Total scores range from 6 to 42 where higher scores indicate a stronger working alliance.
Change in Healthy Minds Index (HM Index): Awareness	Baseline, weeks 1, 2, 3, 4, and 3 months	The HM Index assesses qualities trained in the HMP and HMRP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. There are 4 awareness items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more awareness.
Change in Wellbeing Growth Mindset	Baseline, weeks 1, 2, 3, 4, and 3 months	Well-being Growth Mindset is a 3-item questionnaire assessing participants' perception of the malleability of wellbeing. It is scored on a 1- to 6-point Likert scale where 1 = strongly disagree and 6 = strongly agree. Total scores range from 3 to 18 where higher scores indicate more of a growth mindset (i.e., wellbeing is malleable).
HMP App Utilization: Days	Study duration (4 weeks)	Number of days the app was accessed.
Change in Healthy Minds Index (HM Index): Insight	Baseline, weeks 1, 2, 3, 4, and 3 months	The HM Index assesses qualities trained in the HMP and HMRP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. There are 3 insight items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more insight.
Change in Experiences Questionnaire (EQ) Decentering Subscale	Baseline, weeks 1, 2, 3, 4, and 3 months	Experiences Questionnaire Decentering is an 11-item questionnaire assessing the psychological capacity of decentering. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = all the time. Mean scores are reported for a total range from 1 to 5 where higher scores indicate more decentering.
Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale	Baseline, weeks 1, 2, 3, 4, and 3 months	FFMQ Awareness is a 8-item questionnaire assessing mindful awareness. It is scored on a 1- to 5-point Likert scale where 1 = never or very rarely true and 5 = very often or always true. Mean scores are reported with a range from 1 to 5 where higher scores indicate more mindful awareness.
Change in Healthy Minds Index (HM Index): Purpose	Baseline, weeks 1, 2, 3, 4, and 3 months	The HM Index assesses qualities trained in the HMP and HMRP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. There are 4 purpose items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more purpose.
Change in Perceived Stress Scale (PSS-10)	Baseline, weeks 1, 2, 3, 4, and 3 months	The PSS-10 is a 10-item scale assessing perceived stress. It is scored on a 0- to 4-point Likert scale where 0 = never and 4 = very often. Mean scores are reported for a range from 0 to 40 where higher scores indicate greater stress.
HMP App Utilization: Number of Activities	Study duration (4 weeks)	Number of activities completed
Change in Subjective Happiness Scale	Baseline, weeks 1, 2, 3, 4, and 3 months	The SHS is a 4-item scale of global subjective happiness. It is scored on a 1- to 7-point Likert scale where 1 = less happy and 7 = more happy. Mean scores are reported for a range from 4 to 28 where higher scores indicate more happiness.
Change in Flourishing Measure	Baseline, weeks 1, 2, 3, 4, and 3 months	This is a 12-item questionnaire used to assess various domains of flourishing, or human well-being. It is scored on a 0- to 10-point Likert scale where 0 = poor and 10 = excellent. Mean scores are reported for a range from 0 to 120 where higher scores indicate greater human well-being.
Change in NIH Toolbox Loneliness	Baseline, weeks 1, 2, 3, 4, and 3 months	NIH Toolbox Loneliness is a 5-item questionnaire assessing loneliness. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = always. Mean scores are reported for a range from 1 to 5 where higher scores indicate more loneliness.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose	Baseline, weeks 1, 2, 3, 4, and 3 months	PROMIS Meaning and Purpose is a 37-item questionnaire assessing sense of meaning and purpose. It is scored on a 1- to 5-point Likert scale where 1 = not at all and 5 = very much. Mean scores are reported for a range from 37 to 185 where higher scores indicate greater sense of meaning and purpose.
Change in Healthy Minds Index (HM Index): Connection	Baseline, weeks 1, 2, 3, 4, and 3 months	The HM Index assesses qualities trained in the HMP and HMRP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. There are 6 connection items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more connection.
Change in Satisfaction with Life Scale (SWLS)	Baseline, weeks 1, 2, 3, 4, and 3 months	The SWLS is a 5-item scale of subjective satisfaction with life. It is scored on a 1- to 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Mean scores are reported for a range from 5 to 35 where higher scores indicate greater satisfaction.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States