Clinical trial NCT06282523: Healthy Minds Comparison Study
Official title: Healthy Minds Comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Depression/Anxiety
Keywords: meditation
mindfulness
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
Secondary outcomes:
measure: HMP App Utilization: Days
timeFrame: Study duration (4 weeks)
measure: HMP App Utilization: Number of Activities
timeFrame: Study duration (4 weeks)
measure: HMP App Utilization: Minutes
timeFrame: Study duration (4 weeks)
measure: Change in Healthy Minds Index (HM Index): Awareness
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
measure: Change in Healthy Minds Index (HM Index): Connection
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
measure: Change in Healthy Minds Index (HM Index): Purpose
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
measure: Change in Healthy Minds Index (HM Index): Insight
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
measure: Change in Subjective Happiness Scale
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
measure: Change in Satisfaction with Life Scale (SWLS)
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
measure: Change in Perceived Stress Scale (PSS-10)
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
measure: Change in Flourishing Measure
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
measure: Change in Digital Working Alliance Inventory (DWAI)
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
measure: Change in Experiences Questionnaire (EQ) Decentering Subscale
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
measure: Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
measure: Change in NIH Toolbox Loneliness
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
measure: Change in Wellbeing Growth Mindset
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose
timeFrame: Baseline, weeks 1, 2, 3, 4, and 3 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Simon Goldberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: