Behavior, Biology and Well-Being Study (BeWell)

University of Wisconsin (UW)

Status

Completed

Conditions

Depression

Psychological Distress

Treatments

Device: Healthy Minds Program

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05183867

1U24AT011289-01 (U.S. NIH Grant/Contract)

2021-0991

Protocol Version 6/29/2023 (Other Identifier)

A487400 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Depression is highly prevalent and associated with extreme personal and societal costs. Meditation training reduces depression symptoms and psychological distress, but access to in-person programs is limited due to associated cost and lack of available services. Research on neurocognitive and biological mechanisms of mediation training in alleviating depression is at a preliminary stage, and an obstacle limiting research progress is over-reliance on retrospective self-report measures, which are vulnerable to a host of biases. This project will use gold-standard behavioral measures and explore novel measures of relevant neurocognitive and behavioral processes, namely pattern separation, self-referential thought, and video-based assessment of emotional well-being. Furthermore, the project will investigate effects on the gut microbiome (with fecal samples) and inflammation (with dried blood spots), which reflect biological systems hypothesized to be mechanistically related to benefits of meditation and well-being training.

Enrollment

1,170 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Elevated PHQ-8 or PHQ-9 ≥ 5 at screening and pre-baseline interview
Proficient in English
Able to provide informed consent
Have access to a smartphone that can download apps from Google Play or the Apple App Store
For payment purposes, must be a US citizen or a permanent US resident

Exclusion criteria

Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component
- Previous use of Healthy Minds Program app
Current suicidal intent and/or high self-injury risk (determined from the interview)
Self-reported history of psychosis
Self-reported history of mania
Current psychopathology that interferes with study participation as assessed by interview
Living or traveling outside the US during the whole study participation period (trips outside US after the interview phase is not an exclusion)
Alcohol Use Disorders Identification Test (AUDIT) score ≥ 13 for women and AUDIT score ≥ 15 for men
Drug Use Disorders Identification Test (DUDIT) score ≥ 8 for women and men

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,170 participants in 3 patient groups

Healthy Minds Program (HMP) app

Experimental group

Description:

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.

Treatment:

Device: Healthy Minds Program

Psychoeducation app

Active Comparator group

Description:

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.

Treatment:

Device: Healthy Minds Program

Usual Care

No Intervention group

Description:

Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care.

Trial documents