Clinical trial NCT05229406: Healthy Minds Program App Dosage
Official title: Healthy Minds Program (HMP) App Dosage Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Anxiety
Psychological Distress
Keywords: depression
anxiety
behavioral symptoms
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-02-08
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to two groups in a 1:1 ratio
Primary purpose: TREATMENT

Brief summary: The study will evaluate the effectiveness of the Healthy Minds Program (HMP) meditation app on participants experiencing depression and/or anxiety. Participants will be assigned to use the HMP app 5- or 15-minutes per day for 4 weeks.

Detailed description: Depression and anxiety are highly common, but access to evidence-based treatments is limited. Meditation training delivered through mobile health (mHealth) technology may increase access to effective strategies. However, the necessary dosage of meditation practice to produce benefits is unknown. This project will investigate the feasibility, acceptability, and preliminary effectiveness of the HMP app for depression and/or anxiety and the feasibility of randomly assigning participants to practice dosages. Further, the project will provide a preliminary evaluation of the linkages between practice dosage and outcomes assessed retrospectively and in-the-moment via ecological momentary assessment (EMA).

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Access to a smartphone or device capable of downloading HMP app
* Self-reported willingness to complete 1-2 min survey 4 times per day on phone for 4 weeks
* Able to speak, read, and write in English
* PROMIS Depression or PROMIS Anxiety \>55

Exclusion Criteria:

* Meditation retreat experience
* Regular meditation practice (weekly practice for over 1 year OR daily practice within the previous 6 months)
* Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course
* PROMIS Depression \>70
* AUDIT C score greater than or equal to 4 for men, and greater than or equal to 3 for non-men (any other genders)

Primary outcomes:
measure: Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App
timeFrame: Baseline to post-test (week 4)
measure: Dosage Adherence: Number of Participants Adhering to Their Dosage Greater Than or Equal to 50 Percent of the Days
timeFrame: Baseline to post-test (week 4)
measure: Percentage of EMA Completed
timeFrame: Baseline to post-test (week 4)
measure: Study Completion Rate
timeFrame: Baseline to post-test (week 4)
measure: Number of Participants Completing Practices ≥50% of Days
timeFrame: Baseline to post-test (week 4)
measure: Modified System Usability Scale (MSUS)
timeFrame: Post-test (week 4)
measure: Change in Attitudes Towards Psychological Online Interventions (ATPOI)
timeFrame: Baseline, and post-test (week 4)
measure: HMP App Utilization: Minutes
timeFrame: Baseline to post-test (week 4)
measure: HMP App Utilization: Days
timeFrame: Baseline to post-test (week 4)
measure: HMP App Utilization: Number of Activities
timeFrame: Baseline to post-test (week 4)
Secondary outcomes:
measure: Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety
timeFrame: Baseline, and post-test (week 4)
measure: Change in Healthy Minds Index (HM Index): Awareness
timeFrame: Baseline, and post-test (week 4)
measure: Change in Healthy Minds Index (HM Index): Connection
timeFrame: Baseline, and post-test (week 4)
measure: Change in Healthy Minds Index (HM Index): Insight
timeFrame: Baseline, and post-test (week 4)
measure: Change in Healthy Minds Index (HM Index): Purpose
timeFrame: Baseline, and post-test (week 4)
measure: Change in Wellbeing Growth Mindset
timeFrame: Baseline, and post-test (week 4)
measure: Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale
timeFrame: Baseline, and post-test (week 4)
measure: Change in NIH Toolbox Loneliness
timeFrame: Baseline, and post-test (week 4)
measure: Change in Experiences Questionnaire (EQ) Decentering Subscale
timeFrame: Baseline, and post-test (week 4)
measure: Change in Meaning in Life Questionnaire (MLQ) Presence Subscale
timeFrame: Baseline, and post-test (week 4)
measure: Change in PROMIS Sleep Disturbance
timeFrame: Baseline, and post-test (week 4)
measure: Count of Participant Responses to Adverse Event Relevant Survey Item
timeFrame: up to 4 weeks
Other outcomes:
measure: Change in EMA-assessed Psychological Distress (Composite of Depression and Anxiety Items)
timeFrame: 4 times per day from baseline to post-test (week 4)
measure: Change in EMA-assessed Mindfulness of Activities
timeFrame: 4 times per day from baseline to post-test (week 4)
measure: Change in EMA-assessed Mindfulness of Feelings / Emotions
timeFrame: 4 times per day from baseline to post-test (week 4)
measure: Change in EMA-assessed Loneliness
timeFrame: 4 times per day from baseline to post-test (week 4)
measure: Change in EMA-assessed Connection With Others
timeFrame: 4 times per day from baseline to post-test (week 4)
measure: Change in EMA-assessed Decentering
timeFrame: 4 times per day from baseline to post-test (week 4)
measure: Change in EMA-assessed Insight
timeFrame: 4 times per day from baseline to post-test (week 4)
measure: Change in EMA-assessed Purpose
timeFrame: 4 times per day from baseline to post-test (week 4)
measure: Change in EMA-assessed Stressor Exposure
timeFrame: 4 times per day from baseline to post-test (week 4)
measure: Change in EMA-assessed Personal Values / Meaning
timeFrame: 4 times per day from baseline to post-test (week 4)
measure: Change in EMA-assessed Rumination
timeFrame: 4 times per day from baseline to post-test (week 4)
measure: Change in EMA-assessed Informal Practice
timeFrame: 4 times per day from baseline to post-test (week 4)
measure: Change in Pre- and Post-practice Positive Affect
timeFrame: Before and after meditation practices between baseline and post-test (week 4)
measure: Change in Pre- and Post-practice Negative Affect
timeFrame: Before and after meditation practices between baseline and post-test (week 4)
measure: Change in Post-practice Focus
timeFrame: Before and after meditation practices between baseline and post-test (week 4)
measure: Digital Working Alliance Inventory (DWAI)
timeFrame: Post-test (week 4)
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: