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Behavioural Intervention

Healthy Minds Program for Depression (BeWell Trial)

N/A

Waitlist Available

Led By Richard Davidson

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Proficient in English

Able to provide informed consent

Must not have

Elevated PHQ-8 or PHQ-9 ≥ 5 at screening and pre-baseline interview

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1, week 2, week 3, week 4, and 3 month follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if the Healthy Minds Program app can help promote well-being in adults with depression symptoms.

Who is the study for?

This trial is for US adults who feel sad or can't enjoy daily activities, can consent to participate, speak English, and have a smartphone. It's not for those with a history of psychosis or mania or high depression scores (PHQ-8/9 ≥ 5).

What is being tested?

The study tests the Healthy Minds Program app against an active control without meditation and a waitlist group. The aim is to see if the app improves well-being in people with depression over four weeks.

What are the potential side effects?

Since this trial involves using an app designed for improving mental health, side effects may include discomfort from confronting personal issues during use but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You must be able to speak and understand English well.

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You understand the study and agree to participate in it.

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You need to have a smartphone that can download apps from Google Play or the Apple App Store.

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You must be either a citizen of the United States or have permanent residency in the United States in order to receive payment.

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You have never experienced episodes of severe mental illness, such as psychosis or mania.

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I feel sad and don't enjoy daily activities anymore.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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You have reported symptoms of depression with a score of 5 or higher on the PHQ-8 or PHQ-9 questionnaire.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1, week 2, week 3, week 4, and 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1, week 2, week 3, week 4, and 3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, week 2, week 3, week 4, and 3-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score

Secondary study objectives

Change in Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score

Change in Awareness Measured by Five Facet Mindfulness Questionnaire Acting with Awareness Subscale Score

Change in Climate Change Anxiety Scale

+16 more

Other study objectives

Change in Digital Working Alliance Inventory

Change in Facial Behavior

Change in Inclusion of Nature in Self

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Healthy Minds Program (HMP) appExperimental Treatment1 Intervention

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.

Group II: Psychoeducation appActive Control1 Intervention

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.

Group III: Usual CareActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Healthy Minds Program

2022

N/A

~300

0 / 7Eligibility criteria met