Verified

Behavioural Intervention

Healthy Minds Program for Depression

University of Wisconsin, Madison, WI Verified

Targeting 2 different conditionsHealthy Minds ProgramN/ARecruitingLed by Richard DavidsonResearch Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

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

Must have

For payment purposes, must be a US citizen or a permanent US resident

Proficient in English

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Study Summary

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

Eligible Conditions

Depression
Psychological Distress

Eligibility Criteria

Inclusion Criteria

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

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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 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 are feeling sad and not enjoying your usual activities.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 outcome measures

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.

0 / 6Eligibility criteria met

Find a site

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,118 Previous Clinical Trials

2,935,385 Total Patients Enrolled

16 Trials studying Depression

8,169 Patients Enrolled for Depression

Hope for Depression Research FoundationOTHER

2 Previous Clinical Trials

45 Total Patients Enrolled

2 Trials studying Depression

45 Patients Enrolled for Depression

National Center for Complementary and Integrative Health (NCCIH)NIH

808 Previous Clinical Trials

665,690 Total Patients Enrolled

59 Trials studying Depression

31,573 Patients Enrolled for Depression

Richard DavidsonPrincipal Investigator

UW-Madison, Center for Healthy Minds

Simon Goldberg, PhDPrincipal Investigator

UW-Madison, Center for Healthy Minds

2 Previous Clinical Trials

475 Total Patients Enrolled

1 Trials studying Depression

92 Patients Enrolled for Depression

Media Library

Healthy Minds Program (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05183867 — N/A

Depression Research Study Groups: Healthy Minds Program (HMP) app, Psychoeducation app, Usual Care

Depression Clinical Trial 2023: Healthy Minds Program Highlights & Side Effects. Trial Name: NCT05183867 — N/A

Healthy Minds Program (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05183867 — N/A

Depression Patient Testimony for trial: Trial Name: NCT05183867 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who has the prerequisites to join this scientific experiment?

"This study is recruiting roughly 1500 participants who are aged 18 to 65 years old and have depression. Qualified individuals should consider applying for this trial."

Answered by AI

Does this clinical experiment have an age restriction, and if so can those over 50 apply?

"This clinical trial is open to adults between the age of 18 and 65."

Answered by AI

Are there any opportunities for new participants to join this experiment?

"Indeed, the information available on clinicaltrials.gov confirms that this study is still actively seeking participants as of August 8th 2022. Initially posted in March 24th 2021, it requires 1500 patients to be recruited from a single medical centre."

Answered by AI

How many individuals have signed up to participate in this experiment?

"Affirmative. According to data on clinicaltrials.gov, this clinical trial is currently recruiting participants; first posted on March 24th 2022, and last updated August 8th 2022. To be successful, the study requires 1500 volunteers from a single medical centre."

Answered by AI