Phase 1 N=92 Randomized Treatment

Healthy Minds Program App Dosage

Depression · Anxiety · Psychological Distress

Bottom Line

View on ClinicalTrials.gov: NCT05229406 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App — 46; 46 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: HMP app (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App	46; 46	—
PRIMARY Dosage Adherence: Number of Participants Adhering to Their Dosage Greater Than or Equal to 50 Percent of the Days	22; 16	—
PRIMARY Percentage of EMA Completed	82.71; 78.61	—
PRIMARY Study Completion Rate	45; 44	—
PRIMARY Number of Participants Completing Practices ≥50% of Days	32; 26	—
PRIMARY Modified System Usability Scale (MSUS)	84.56; 83.66	—
PRIMARY Change in Attitudes Towards Psychological Online Interventions (ATPOI)	3.30; 3.20; 3.45; 3.47; 0.15; 0.27	—
PRIMARY HMP App Utilization: Minutes	100.85; 201.76	—
PRIMARY HMP App Utilization: Days	17.28; 14.72	—
PRIMARY HMP App Utilization: Number of Activities	57.65; 51.43	—
SECONDARY Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety	60.93; 61.08; 57.28; 56.78; -3.58; -4.44	—
SECONDARY Change in Healthy Minds Index (HM Index): Awareness	3.29; 3.26; 3.42; 3.40; 0.13; 0.12	—
SECONDARY Change in Healthy Minds Index (HM Index): Connection	3.56; 3.55; 3.72; 3.87; 0.16; 0.34	—
SECONDARY Change in Healthy Minds Index (HM Index): Insight	2.86; 2.77; 3.11; 3.33; 0.27; 0.56	—
SECONDARY Change in Healthy Minds Index (HM Index): Purpose	3.43; 3.49; 3.80; 3.88; 0.38; 0.40	—
SECONDARY Change in Wellbeing Growth Mindset	13.77; 13.48; 14.60; 15.11; 0.68; 1.59	—
SECONDARY Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale	3.04; 2.91; 3.22; 3.30; 0.16; 0.37	—
SECONDARY Change in NIH Toolbox Loneliness	2.76; 2.82; 2.20; 2.11; -0.54; -0.75	—
SECONDARY Change in Experiences Questionnaire (EQ) Decentering Subscale	2.85; 3.06; 3.30; 3.56; 0.46; 0.52	—
SECONDARY Change in Meaning in Life Questionnaire (MLQ) Presence Subscale	3.58; 3.62; 4.27; 4.53; 0.74; 0.93	—
SECONDARY Change in PROMIS Sleep Disturbance	55.56; 53.77; 50.23; 48.84; -5.20; -5.04	—
SECONDARY Count of Participant Responses to Adverse Event Relevant Survey Item	30; 33; 9; 5; 4; 4	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05229406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.