Healthy Minds Comparison Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Anxiety; Depression/Anxiety
• Intervention / Treatment: Behavioral: HMP app; Behavioral: HMRP web app

• Study Type: Interventional
• Enrollment (Estimated): 460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon Goldberg, PhD; Phone Number: 608-265-8986; Email: sbgoldberg@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin
      • Contact: Simon Goldberg, PhD; Phone Number: 608-265-8986; Email: sbgoldberg@wisc.edu
      • Principal Investigator: Simon Goldberg, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Minds Program (HMP) - Awareness first; Participants will be assigned to use the HMP mobile app on symptoms of psychological distress, and will complete the Awareness module first.	Behavioral: HMP app; The HMP app is a meditation-based smartphone app 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 guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Experimental: Healthy Minds Research Platform (HMRP) - Awareness first; Participants will be assigned to use the HMRP web app on symptoms of psychological distress, and will complete the Awareness module first.	Behavioral: HMRP web app; The HMRP web app is a meditation-based web-based app 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. HMRP provides core content, with instruction administered through a curriculum of guided practices. HMRP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Experimental: HMP - Connection first; Participants will be assigned to use the HMP mobile app on symptoms of psychological distress, and will complete the Connection module first.	Behavioral: HMP app; The HMP app is a meditation-based smartphone app 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 guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Experimental: HMRP - Connection first; Participants will be assigned to use the HMRP web app on symptoms of psychological distress, and will complete the Connection module first.	Behavioral: HMRP web app; The HMRP web app is a meditation-based web-based app 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. HMRP provides core content, with instruction administered through a curriculum of guided practices. HMRP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety	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.	Baseline, weeks 1, 2, 3, 4, and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HMP App Utilization: Days	Number of days the app was accessed.	Study duration (4 weeks)
HMP App Utilization: Number of Activities	Number of activities completed	Study duration (4 weeks)
HMP App Utilization: Minutes	Minutes of meditation practice completed	Study duration (4 weeks)
Change in Healthy Minds Index (HM Index): Awareness	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.	Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Healthy Minds Index (HM Index): Connection	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.	Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Healthy Minds Index (HM Index): Purpose	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.	Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Healthy Minds Index (HM Index): Insight	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.	Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Subjective Happiness Scale	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.	Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Satisfaction with Life Scale (SWLS)	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.	Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Perceived Stress Scale (PSS-10)	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.	Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Flourishing Measure	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.	Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Digital Working Alliance Inventory (DWAI)	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.	Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Experiences Questionnaire (EQ) Decentering Subscale	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.	Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale	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.	Baseline, weeks 1, 2, 3, 4, and 3 months
Change in NIH Toolbox Loneliness	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.	Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Wellbeing Growth Mindset	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).	Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose	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.	Baseline, weeks 1, 2, 3, 4, and 3 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Simon Goldberg, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: mindfulness; meditation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: 2023-1773; A171600 (Other Identifier: UW- Madison); EDUC/COUNSELING PSYCH (Other Identifier: UW- Madison); Protocol Version 12/27/23 (Other Identifier: UW- Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No