Healthy Minds Comparison Study

Depression Clinical Trial

Official title:

Healthy Minds Comparison Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282523
• Other study ID #: 2023-1773
• Secondary ID: A171600EDUC/COUN
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2024
• Est. completion date: August 2024

Study information

• Verified date: June 2024
• Source: University of Wisconsin, Madison
• Contact: Simon Goldberg, PhD
• Phone: 608-265-8986
• Email: sbgoldberg[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depression/Anxiety
• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin	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 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	HMP App Utilization: Days	Number of days the app was accessed.	Study duration (4 weeks)
Secondary	HMP App Utilization: Number of Activities	Number of activities completed	Study duration (4 weeks)
Secondary	HMP App Utilization: Minutes	Minutes of meditation practice completed	Study duration (4 weeks)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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