Massed and Spaced HMP App Dosage Study

Massed and Spaced Healthy Minds Program App Dosage Study

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.

Study Overview

• Status: Completed
• Conditions: Psychological Distress; Loneliness; Depression, Anxiety
• Intervention / Treatment: Behavioral: Healthy Minds Program app

• Study Type: Interventional
• Enrollment (Actual): 351
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • University of Wisconsin - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Massed condition; 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; 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.
EXPERIMENTAL: Spaced condition; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the PROMIS (Patient-Reported Outcomes Measurement Information System) Depression score	Psychological distress computed as composite of 4-item PROMIS Depression measures. Scores range from 4 to 20 with higher scores representing worse symptoms.	Baseline and 2 weeks
Change in the PROMIS Anxiety score	Psychological distress computed as composite of 4-item PROMIS Anxiety measures. Scores range from 4 to 20 with higher scores representing worse symptoms.	Baseline and 2 weeks
Change in NIH Toolbox Loneliness score	NIH toolbox loneliness measures the perceptions that one is alone, lonely, or socially isolated from others. It is a 5-item scale. Total score range = 5 to 25, lower score is better	Baseline and 2 weeks
Change in Self-Compassion Short Form score	This 12-item measure assesses participant's self-compassion ability, total score range = 12 to 60, higher scores correlate to more self-compassion.	Baseline and 2 weeks
Change in Fear of Missing Out scale score	Fear of missing out is a 10 item scale. Total score range = 10 to 50, lower score is better	Baseline and 2 weeks
Change in Acceptance and Action Questionnaire - II score	Acceptance and Action Questionnaire- II measures psychological flexibility Experiential avoidance, total score range = 7 to 49. Higher total scores mean less flexibility, while lower total scores mean more flexibility. Lower score is better.	Baseline and 2 weeks
Single item loneliness score	"How lonely did you feel today?", range = 1 to 7, lower score is better	Up to 2 weeks
Highest loading PROMIS Depression and PROMIS Anxiety items score	Composite of highest loading PROMIS items modified to reference "today," z-transformed to have mean of 0 and standard deviation of 1, lower score is better.	Up to 2 weeks
Single item informal meditation practice	Single item informal meditation practice measure, "As you reflect on today, to what extent did you apply these practices?" Scores range from 0 to 100. A higher score is better.	Up to 2 weeks
Digital Working Alliance Inventory score	The Digital Working Alliance Inventory measures the therapeutic relationship between participant and HMP app. Total score range = 6 to 42, higher score is better.	2 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Simon B Goldberg, PhD, UW-Madison

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 9, 2021
• Primary Completion (ACTUAL): May 18, 2021
• Study Completion (ACTUAL): May 18, 2021

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (ACTUAL): February 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2020-1454; A171600 (Other Identifier: UW Madison); EDUC/COUNSELING PSYCH (Other Identifier: UW Madison); Protocol Approval 1/11/2021 (OTHER: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be de-identified and listed in public data registries (i.e., osf) based on the publication of preregistered study hypotheses on a manuscript by manuscript basis.
• IPD Sharing Time Frame: Data may be shared following analysis and publication or upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No