Massed and Spaced HMP App Dosage Study

NCT04741529 | Completed

• 4 other identifiers: 2020-1454A171600EDUC/COUNSELING PSYCHProtocol Approval 1/11/2021
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Percentage of participants who completed the study

  2 weeks

• Number of meditation sessions per day using the HMP app

  2 weeks

• Number of minutes of meditation practice using the HMP app

  2 weeks

• System Usability Scale score

  System usability scale is (SUS) is a 10-item Likert scale questionnaire that provides information on the ease of use (or lack thereof) of websites, software, hardware, mobile devices, and other technological applications. Higher SUS score correlates to better usability of an app, total score range = 0 to 100

  2 weeks

Secondary Outcomes (10)

• Change in the PROMIS (Patient-Reported Outcomes Measurement Information System) Depression score

  Baseline and 2 weeks

• Change in the PROMIS Anxiety score

  Baseline and 2 weeks

• Change in NIH Toolbox Loneliness score

  Baseline and 2 weeks

• Change in Self-Compassion Short Form score

  Baseline and 2 weeks

• Change in Fear of Missing Out scale score

  Baseline and 2 weeks

Study Arms (2)

Massed condition

EXPERIMENTAL

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

Behavioral: Healthy Minds Program app

Spaced condition

EXPERIMENTAL

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

Behavioral: Healthy Minds Program app

Interventions

Healthy Minds Program app 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.

Massed condition; Spaced condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53706, United States

Location

Related Publications (1)

• 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.

  PMID: 38376930 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Simon B Goldberg, PhD

  UW-Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 5, 2021
• Study Start: March 9, 2021
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data may be shared following analysis and publication or upon request.

Locations

US (1)