Healthy Minds Program App Dosage

NCT05229406 | Completed Phase 1 Results

• 6 other identifiers: 2019-1578MSN227550A171600EDUC/COUNSELING PSYCH01/21/20221K23AT010879-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate the effectiveness of the Healthy Minds Program (HMP) meditation app on participants experiencing depression and/or anxiety. Participants will be assigned to use the HMP app 5- or 15-minutes per day for 4 weeks.

Conditions

Depression; Anxiety; Psychological Distress

Keywords

depression; anxiety; behavioral symptoms

Outcome Measures

Primary Outcomes (10)

• Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App

  Percentage of those randomized completing ecological momentary assessment (EMA) assessments and activities in the Healthy Minds Program (HMP) app

  Baseline to post-test (week 4)

• Dosage Adherence: Number of Participants Adhering to Their Dosage Greater Than or Equal to 50 Percent of the Days

  Number of participants adhering to their assigned dosage greater than or equal to 50 percent of the days. This was assessed directly through the HMP app.

  Baseline to post-test (week 4)

• Percentage of EMA Completed

  Percentage of EMA assessments that were completed

  Baseline to post-test (week 4)

• Study Completion Rate

  Percentage of participants completing pre- and post-test measures

  Baseline to post-test (week 4)

• Number of Participants Completing Practices ≥50% of Days

  Number of participants completing practices ≥50% of days

  Baseline to post-test (week 4)

• Modified System Usability Scale (MSUS)

  The MSUS is a 10-item questionnaire where participants report their experience of the usability of a product, in this case the HMP app. It is scored on a 1- to 5-point Likert scale where 1 = strongly disagree and 5 = strongly agree. The result was rescaled to range from 0 to 100 with higher scores indicate higher usability.

  Post-test (week 4)

• Change in Attitudes Towards Psychological Online Interventions (ATPOI)

  The ATPOI is a 16-item questionnaire where participants report their perception of psychological online interventions. It is scored on a 1- to 5-point Likert scale where 1 = totally disagree and 5 = totally agree. Mean scores are reported for a total possible range of scores is 1 to 5 where higher scores indicate more positive attitudes towards psychological online interventions.

  Baseline, and post-test (week 4)

• HMP App Utilization: Minutes

  Minutes of meditation practice completed

  Baseline to post-test (week 4)

• HMP App Utilization: Days

  Number of days the app was accessed.

  Baseline to post-test (week 4)

• HMP App Utilization: Number of Activities

  Baseline to post-test (week 4)

Secondary Outcomes (12)

• Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety

  Baseline, and post-test (week 4)

• Change in Healthy Minds Index (HM Index): Awareness

  Baseline, and post-test (week 4)

• Change in Healthy Minds Index (HM Index): Connection

  Baseline, and post-test (week 4)

• Change in Healthy Minds Index (HM Index): Insight

  Baseline, and post-test (week 4)

• Change in Healthy Minds Index (HM Index): Purpose

  Baseline, and post-test (week 4)

Other Outcomes (16)

• Change in EMA-assessed Psychological Distress (Composite of Depression and Anxiety Items)

  4 times per day from baseline to post-test (week 4)

• Change in EMA-assessed Mindfulness of Activities

  4 times per day from baseline to post-test (week 4)

• Change in EMA-assessed Mindfulness of Feelings / Emotions

  4 times per day from baseline to post-test (week 4)

Study Arms (2)

5-minute app usage

EXPERIMENTAL

Participants will be asked to use the HMP app for 5-minutes per day.

Behavioral: HMP app

15-minute app usage

EXPERIMENTAL

Participants will be asked to use the HMP app for 15-minutes per day.

Behavioral: HMP app

Interventions

HMP app BEHAVIORAL

The HMP app is a meditation-based smartphone app 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 guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.

15-minute app usage; 5-minute app usage

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Access to a smartphone or device capable of downloading HMP app
• Self-reported willingness to complete 1-2 min survey 4 times per day on phone for 4 weeks
• Able to speak, read, and write in English
• PROMIS Depression or PROMIS Anxiety \>55

You may not qualify if:

• Meditation retreat experience
• Regular meditation practice (weekly practice for over 1 year OR daily practice within the previous 6 months)
• Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course
• PROMIS Depression \>70
• AUDIT C score greater than or equal to 4 for men, and greater than or equal to 3 for non-men (any other genders)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (2)

• Dyer RL, Zimmerman KM, Zhao X, Xie Q, Dahl CJ, Quanbeck A, Goldberg SB. Developing meditation practice in individuals with elevated psychological distress via a meditation app intervention: An implementation science-informed qualitative investigation of barriers and facilitators. Psychol Serv. 2025 Jul 10:10.1037/ser0000980. doi: 10.1037/ser0000980. Online ahead of print.

  PMID: 40638276 DERIVED

• Xie Q, Dyer RL, Lam SU, Frye C, Dahl CJ, Quanbeck A, Nahum-Shani I, Davidson RJ, Goldberg SB. Understanding the Implementation of Informal Meditation Practice in a Smartphone-Based Intervention: A Qualitative Analysis. Mindfulness (N Y). 2024 Feb;15(2):479-490. doi: 10.1007/s12671-024-02304-x. Epub 2024 Jan 22.

  PMID: 39070019 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders

Limitations and Caveats

This study was not powered to detect between-group differences on pre-post outcomes. Here results are reported by arm for descriptive purposes.

Results Point of Contact

• Title: Simon B. Goldberg, PhD
• Organization: Center for Healthy Minds, University of Wisconsin - Madison

sbgoldberg@wisc.edu

608-265-8986

Study Officials

• Simon Goldberg, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to two groups in a 1:1 ratio

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 8, 2022
• Study Start: February 21, 2022
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data may be shared following analysis and publication or upon request.
• Access Criteria: Researcher consent. Any reasonable request will be granted.

Locations

US (1)