Healthy Minds Comparison Study
- Conditions
- DepressionAnxietyDepression/Anxiety
- Interventions
- Behavioral: HMRP web appBehavioral: HMP app
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 532
- Age ≥18 years
- Elevated symptoms of depression and anxiety
- Proficient in English
- Access to a smartphone
- 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
- Arm && Interventions
Group Intervention Description HMRP - Connection first HMRP web app Participants will be assigned to use the HMRP web app on symptoms of psychological distress, and will complete the Connection module first. Healthy Minds Program (HMP) - Awareness first HMP app Participants will be assigned to use the HMP mobile app on symptoms of psychological distress, and will complete the Awareness module first. HMP - Connection first HMP app Participants will be assigned to use the HMP mobile app on symptoms of psychological distress, and will complete the Connection module first. Healthy Minds Research Platform (HMRP) - Awareness first HMRP web app Participants will be assigned to use the HMRP web app on symptoms of psychological distress, and will complete the Awareness module first.
- 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