Anxiety, Depression, Depression/Anxiety
Conditions
Keywords
meditation, mindfulness
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.
Interventions
BEHAVIORALHMP 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.
BEHAVIORALHMRP 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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| HMP App Utilization: Number of Activities | Study duration (4 weeks) | Number of activities completed |
| HMP App Utilization: Minutes | Study duration (4 weeks) | Minutes of meditation practice completed |
| 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 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 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 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 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 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. |
| HMP App Utilization: Days | Study duration (4 weeks) | Number of days the app was accessed. |
| 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 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 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 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 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). |
| 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 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. |
Countries
United States
Outcome results
None listed