Massed and Spaced HMP App Dosage Study

NCT ID: NCT04741529

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 351 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-09
• Study Completion Date: 2021-05-18

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.

Conditions

Depression, Anxiety; Psychological Distress; Loneliness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Massed condition

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

Group Type: EXPERIMENTAL

Healthy Minds Program app

Intervention Type: BEHAVIORAL

The HMP app was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on the work of Drs. Richard Davidson and Cortland Dahl. HMP is designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of high-quality guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). HMP has >100 guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.

Participants in this study will receive 2 weeks of training in the Connection module of HMP.

Spaced condition

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

Group Type: EXPERIMENTAL

Healthy Minds Program app

Intervention Type: BEHAVIORAL

The HMP app was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on the work of Drs. Richard Davidson and Cortland Dahl. HMP is designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of high-quality guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). HMP has >100 guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.

Participants in this study will receive 2 weeks of training in the Connection module of HMP.

Interventions

Healthy Minds Program app

The HMP app was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on the work of Drs. Richard Davidson and Cortland Dahl. HMP is designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of high-quality guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). HMP has >100 guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.

Participants in this study will receive 2 weeks of training in the Connection module of HMP.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon B Goldberg, PhD

Role: PRINCIPAL_INVESTIGATOR

UW-Madison

Locations

University of Wisconsin - Madison

Madison, Wisconsin, United States

Countries

United States

References

Riordan KM, Simonsson O, Frye C, Vack NJ, Sachs J, Fitch D, Goldman RI, Chiang ES, Dahl CJ, Davidson RJ, Goldberg SB. How often should I meditate? A randomized trial examining the role of meditation frequency when total amount of meditation is held constant. J Couns Psychol. 2024 Mar;71(2):104-114. doi: 10.1037/cou0000725.

Reference Type: DERIVED

PMID: 38376930 (View on PubMed)

Other Identifiers

A171600

Identifier Type: OTHER

Identifier Source: secondary_id

EDUC/COUNSELING PSYCH

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Approval 1/11/2021

Identifier Type: OTHER

Identifier Source: secondary_id

2020-1454

Identifier Type: -

Identifier Source: org_study_id