Healthy Minds Comparison Study

NCT06282523 | Completed DMC

• 4 other identifiers: 2023-1773A171600EDUC/COUNSELING PSYCHProtocol Version 12/27/23
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to understand the difference between two versions of the Healthy Minds application, a digital well-being program. The main question it aims to answer is the differences between versions of the Healthy Minds application and their effects on well-being. Participants will complete an online four-week well-being program and complete surveys sent to their email. Participants can expect to participate in the study for four months.

Conditions

Depression; Anxiety; Depression/Anxiety

Keywords

meditation; mindfulness

Outcome Measures

Primary Outcomes (1)

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

  Psychological distress will be computed as a composite of the PROMIS Depression and PROMIS Anxiety measures. We will use the computer adaptive version of both measures which have a mean of 50 and a standard deviation of 10. A composite will be computed by average across T-scores. T-scores range from 10 to 90 with higher scores indicating higher depression or anxiety.

  Baseline, weeks 1, 2, 3, 4, and 3 months

Secondary Outcomes (17)

• HMP App Utilization: Days

  Study duration (4 weeks)

• HMP App Utilization: Number of Activities

  Study duration (4 weeks)

• HMP App Utilization: Minutes

  Study duration (4 weeks)

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

  Baseline, weeks 1, 2, 3, 4, and 3 months

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

  Baseline, weeks 1, 2, 3, 4, and 3 months

Study Arms (4)

Healthy Minds Program (HMP) - Awareness first

EXPERIMENTAL

Participants will be assigned to use the HMP mobile app on symptoms of psychological distress, and will complete the Awareness module first.

Behavioral: HMP app

Healthy Minds Research Platform (HMRP) - Awareness first

EXPERIMENTAL

Participants will be assigned to use the HMRP web app on symptoms of psychological distress, and will complete the Awareness module first.

Behavioral: HMRP web app

HMP - Connection first

EXPERIMENTAL

Participants will be assigned to use the HMP mobile app on symptoms of psychological distress, and will complete the Connection module first.

Behavioral: HMP app

HMRP - Connection first

EXPERIMENTAL

Participants will be assigned to use the HMRP web app on symptoms of psychological distress, and will complete the Connection module first.

Behavioral: HMRP web 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.

HMP - Connection first; Healthy Minds Program (HMP) - Awareness first

HMRP web app BEHAVIORAL

The HMRP web app is a meditation-based web-based 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. HMRP provides core content, with instruction administered through a curriculum of guided practices. HMRP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.

HMRP - Connection first; Healthy Minds Research Platform (HMRP) - Awareness first

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Elevated symptoms of depression and anxiety
• Proficient in English
• Access to a smartphone

You may not qualify if:

• Prior experience with meditation generally
• Prior use of the Healthy Minds application
• History of psychosis or mania
• Alcohol and/or substance use disorder

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Simon Goldberg, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: June 19, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)