Healthy Minds Program App Dosage

NCT ID: NCT05229406

Last Updated: 2023-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-21

Study Completion Date

2022-06-27

Brief Summary

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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.

Detailed Description

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Depression and anxiety are highly common, but access to evidence-based treatments is limited. Meditation training delivered through mobile health (mHealth) technology may increase access to effective strategies. However, the necessary dosage of meditation practice to produce benefits is unknown. This project will investigate the feasibility, acceptability, and preliminary effectiveness of the HMP app for depression and/or anxiety and the feasibility of randomly assigning participants to practice dosages. Further, the project will provide a preliminary evaluation of the linkages between practice dosage and outcomes assessed retrospectively and in-the-moment via ecological momentary assessment (EMA).

Conditions

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Depression Anxiety Psychological Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to two groups in a 1:1 ratio
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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5-minute app usage

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

Group Type EXPERIMENTAL

HMP app

Intervention Type 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

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

Group Type EXPERIMENTAL

HMP app

Intervention Type 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.

Interventions

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HMP app

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon Goldberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40638276 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39070019 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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MSN227550

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2019-1578

Identifier Type: OTHER

Identifier Source: secondary_id

A171600

Identifier Type: OTHER

Identifier Source: secondary_id

EDUC/COUNSELING PSYCH

Identifier Type: OTHER

Identifier Source: secondary_id

01/21/2022

Identifier Type: OTHER

Identifier Source: secondary_id

1K23AT010879-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019-1578

Identifier Type: -

Identifier Source: org_study_id

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