Clinical trial NCT04741529: Massed and Spaced HMP App Dosage Study
Official title: Massed and Spaced Healthy Minds Program App Dosage Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Psychological Distress
Loneliness
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a randomized controlled trial (RCT) of 2 weeks of the Healthy Minds Program (HMP) app Connection module in undergraduate students of a large, midwestern state university in the United States during the spring of 2021.

Participants will be recruited via email and/or flyers and will first complete an online screen. Eligible participants will complete baseline measures prior to attending an introductory session via web conferencing. During this session, participants will be randomly assigned to condition. Participants in both conditions will be asked to use the HMP app for 20 minutes per either, either split over two 10-minute session (Spaced condition) or in one 20-minute session (Massed condition). Participants will complete daily survey measures during the study and post-test measures after 2 weeks of intervention.

This study is primarily designed to assess feasibility and acceptability of 2 weeks of Connection training and assignment to dosage condition. Study team will investigate self-reported informal practice on the daily diary measure, measures of psychological distress (composite of depression, anxiety) and loneliness.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Undergraduate at UW-Madison
* Access to a smartphone or device capable of downloading HMP app
* PROMIS Depression or PROMIS Anxiety ≥55

Exclusion Criteria:

* Meditation retreat experience
* Regular meditation practice (i.e., weekly practice for \>1 year OR daily practice within previous 6 months)
* Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course
* PROMIS Depression ≥70

Primary outcomes:
measure: Percentage of participants who completed the study
timeFrame: 2 weeks
measure: Number of meditation sessions per day using the HMP app
timeFrame: 2 weeks
measure: Number of minutes of meditation practice using the HMP app
timeFrame: 2 weeks
measure: System Usability Scale score
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in the PROMIS (Patient-Reported Outcomes Measurement Information System) Depression score
timeFrame: Baseline and 2 weeks
measure: Change in the PROMIS Anxiety score
timeFrame: Baseline and 2 weeks
measure: Change in NIH Toolbox Loneliness score
timeFrame: Baseline and 2 weeks
measure: Change in Self-Compassion Short Form score
timeFrame: Baseline and 2 weeks
measure: Change in Fear of Missing Out scale score
timeFrame: Baseline and 2 weeks
measure: Change in Acceptance and Action Questionnaire - II score
timeFrame: Baseline and 2 weeks
measure: Single item loneliness score
timeFrame: Up to 2 weeks
measure: Highest loading PROMIS Depression and PROMIS Anxiety items score
timeFrame: Up to 2 weeks
measure: Single item informal meditation practice
timeFrame: Up to 2 weeks
measure: Digital Working Alliance Inventory score
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: UW-Madison
name: Simon B Goldberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: