Behavior, Biology and Well-Being Study

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT05183867
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Healthy Minds Program — DEVICE
    HMP is a 4-week mobile health (mHealth) meditation training program.

Study Details

The central aim of this study is to test the efficacy of the Healthy Minds Program (HMP) app, an intervention designed to promote well-being. The investigators plan to conduct a randomized controlled trial (RCT) involving 1100 participants comparing 4-weeks of the HMP app with an active control (Psychoeducation \[HMP without meditation practice\]), and a waitlist control in a sample of United States adults with elevated depression symptoms.

Key Dates

Start date
Mar 24, 2022
Status verified
Aug 2025
Primary completion
Jul 15, 2024
Completion
Jul 15, 2024

Study Design

Enrollment
1,157 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Healthy Minds Program (HMP) app
    Participants will receive access to the 4-week HMP Foundations module. 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 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). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice.
  • Active Comparator: Psychoeducation app
    Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices.
  • No Intervention: Usual Care
    Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.

Primary Outcome Measure

Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score [ Time Frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53703-

Find similar trials in Madison, WI

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Wisconsin· Madison, WI

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