Healthy Minds Program for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Depression+1 More
Healthy Minds Program - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Study Objectives

1 Primary · 20 Secondary · Reporting Duration: week 1, week 2, week 3, week 4, and 3 month follow up

Month 3
Change in Inflammatory Biomarkers
Change in Microbiome Alpha Diversity
Month 3
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 Cognitive Defusion Measured by Drexel Defusion Scale Score
Change in Connection Measured by NIH Toolbox Loneliness Score
Change in Decentering Measured by Decentering Subscale of Experiencing Questionnaire scale score
Change in Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
Change in Flourishing Measured by the Flourishing Index Score
Change in Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score
Change in Negative Affect Word Use
Change in Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score
Change in Self-Referential Pronoun Use
Change in Sleep Disturbance Measured by PROMIS Sleep Disturbance Score
Change in Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
Month 3
Change in Facial Behavior
Change in Inclusion of Nature in Self
Change in Pain Intensity measured by PROMIS Pain Intensity score
Change in Pain Interference measured by PROMIS Pain Inference Scale Score
Change in Pattern Separation Task
Month 3
Change in Climate Change Anxiety Scale
Change in Healthy Minds Index (HM Index)
Change in Life Orientation Test - Revised
Change in Perceived Stress Scale
Change in Perseverative Thinking Questionnaire
Change in Satisfaction with Life Scale
Change in Subjective Happiness Scale
Change in Wellbeing Growth Mindset
Week 4
Change in post-practice focus
Week 4
Change in pre- and post-practice negative affect
Change in pre- and post-practice positive affect
Month 3
Mindfulness Adherence Questionnaire
Week 4
Change in Digital Working Alliance Inventory
week 4
Treatment Expectancies

Trial Safety

Trial Design

3 Treatment Groups

Usual Care
1 of 3
Psychoeducation app
1 of 3
Healthy Minds Program (HMP) app
1 of 3
Active Control
Experimental Treatment

1500 Total Participants · 3 Treatment Groups

Primary Treatment: Healthy Minds Program · No Placebo Group · N/A

Healthy Minds Program (HMP) app
Device
Experimental Group · 1 Intervention: Healthy Minds Program · Intervention Types: Device
Usual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:
Psychoeducation app
Device
ActiveComparator Group · 1 Intervention: Healthy Minds Program · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 1, week 2, week 3, week 4, and 3 month follow up

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
771 Previous Clinical Trials
641,526 Total Patients Enrolled
55 Trials studying Depression
31,235 Patients Enrolled for Depression
University of Wisconsin, MadisonLead Sponsor
1,061 Previous Clinical Trials
2,562,299 Total Patients Enrolled
14 Trials studying Depression
8,353 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
Richard DavidsonPrincipal InvestigatorUW-Madison, Center for Healthy Minds
Simon Goldberg, PhDPrincipal InvestigatorUW-Madison, Center for Healthy Minds
2 Previous Clinical Trials
475 Total Patients Enrolled
1 Trials studying Depression
92 Patients Enrolled for Depression

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have access to a smartphone that can download apps from Google Play or the Apple App Store.
You are a US citizen or a permanent US resident.
You do no thave a history of psychosis or mania
You have elevated PHQ-8 or PHQ-9 ≥ 5 at screening and pre-baseline interview.
You are proficient in English
You are able to provide informed consent
You are experiencing sadness and/or lack of enjoyment of daily activities

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: October 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas18.8%
Florida18.8%
Indiana12.5%
Other50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Wisconsin100.0%
What portion of applicants met pre-screening criteria?
Met criteria21.4%
Did not meet criteria78.6%
Why did patients apply to this trial?
  • "I want to feel better and make money doing it."
  • "I've tried 11 other drugs in 3 month period that haven't worked"
  • "I have good days and I have bad days. My bad days are the realization of the **** I have been through being sick for the last 2 years in a country that refuses to acknowledge the cause. I am angry with the establishment that made me sick. Now they want to let bygones be bygones without accepting responsibility for sickening thousands of people."
How many prior treatments have patients received?
050.0%
3+50.0%

How responsive is this trial?

Most responsive sites:
  1. University of Wisconsin: < 24 hours
Typically responds via
Email100.0%
Average response time
  • < 1 Day