Massed and Spaced HMP App Dosage Study

University of Wisconsin (UW)

Status: Completed

Conditions: Depression, Anxiety; Loneliness; Psychological Distress

Treatments: Behavioral: Healthy Minds Program app

Study type: Interventional

Funder types: Other

Identifiers

NCT04741529

EDUC/COUNSELING PSYCH (Other Identifier)

Protocol Approval 1/11/2021 (Other Identifier)

A171600 (Other Identifier)

2020-1454

Details and patient eligibility

About

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.

Enrollment: 351 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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351 participants in 2 patient groups

Massed condition

Experimental group

Description:

Participant will be asked to use the HMP app for 20 minutes per day in one 20-minute meditation session.

Treatment:

Behavioral: Healthy Minds Program app

Spaced condition

Experimental group

Description:

Participant will be asked to use the HMP app for 20 minutes per day in two 10-minute meditation sessions.

Treatment:

Behavioral: Healthy Minds Program app