Behavior, Biology and Well-Being Study (BeWell)

Comparing the Healthy Minds Program With an Active Control and Waitlist Control in Depression

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.

Study Overview

• Status: Completed
• Conditions: Depression; Psychological Distress
• Intervention / Treatment: Device: Healthy Minds Program

Detailed 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 meditation 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.

• Study Type: Interventional
• Enrollment (Actual): 1157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53703
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Elevated PHQ-8 or PHQ-9 ≥ 5 at screening
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Healthy Minds Program; HMP is a 4-week mobile health (mHealth) meditation training program.; Other Names: HMP
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.	Device: Healthy Minds Program; HMP is a 4-week mobile health (mHealth) meditation training program.; Other Names: HMP
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score	The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-24 where higher scores indicate more depressive symptoms.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score	The GAD-7 is a 7-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-21 where higher scores indicate more anxious symptoms.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score	The PROMIS Sleep Disturbance scale is a computer-adaptive measure where participants report how often in the past 7 days they had various sleep-related experiences (e.g., "my sleep was restful"). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, standard deviation (SD) = 10) where higher scores indicate more sleep disturbance.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Flourishing Measured by the Flourishing Index Score	The Flourishing Index is a 10-item questionnaire where participants report their general level of flourishing (e.g., well-being, health, etc.). It is scored on a 0 to 10-point scale, with anchors varying across items. The total score ranges from 0 to 100 with higher scores indicating higher flourishing.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score	The Five Facet Mindfulness Questionnaire Acting with Awareness Subscale is a 8-item subscale where participants report on their general ability to focus. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater ability to focus.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Connection Measured by NIH Toolbox Loneliness Score	The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score	The Decentering subscale of the Experience Questionnaire is an 11-item questionnaire where participants report on their ability to decenter from their experience. It is scored on a 5-point Likert scale where 1 = never to 5 = all the time. The total possible range of scores is 11-55 where higher scores indicate a greater ability to decenter from experience.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score	The PROMIS / NIH Toolbox Meaning and Purpose is a computer-adaptive measure where participants report how much meaning and purpose they experience in life (e.g., "I understand my life's meaning"). It is scored on a 5-point Likert scale where 1 = strongly disagree to 5 = strongly agree. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more meaning and purpose in life.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Pain Intensity Measured by PROMIS Pain Intensity Score	The single-item PROMIS Pain Intensity scale is a 1-item scale where participants report on their pain intensity in the past 7 days. It is scored on an 11-point Likert-scale where 0 = no pain and 10 = worst pain imaginable. Scores range from 0 to 10, with higher scores indicating higher pain intensity	Baseline, week 4 (of intervention period), and 3 month follow-up
Pain Interference Measured by PROMIS Pain Inference Scale Score	The PROMIS Pain Interference scale is a computer-adaptive measure where participants report how often in the past 7 days they had pain-related interference in their life (e.g., "how much did pain interfere with your enjoyment of life"). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more pain interference.	Baseline, week 4 (of intervention period), and 3 month follow-up
Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score	The Five Facet Mindfulness Questionnaire Nonjudgment Subscale is a 8-item subscale where participants report on their nonjudgment of experience in daily life. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater nonjudgment of experience.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Climate Change Anxiety Scale	The Climate Change Anxiety Scale is a 13-item scale where participants report their anxiety regarding climate change (e.g., "I have nightmares about climate change"). It is scored on a 5-point Likert scale where 1 = "never" to 5 = "almost always." Total scores range from 13 to 65 where higher scores indicate greater climate change anxiety.	Baseline, week 4, and 3 month follow up
Wellbeing Growth Mindset	The Wellbeing Growth Mindset scale is a 3-item scale where participants report whether they believe wellbeing is malleable (e.g., "Your well-being is something about you that you can't change very much."). It is scored on a 6-point Likert scale where 1 = "strongly disagree" to 6 = "strongly agree." Total scores range from 3 to 18 where higher scores indicate greater wellbeing growth mindset.	Baseline, week 4, and 3 month follow up
Healthy Minds Index (HM Index) - Awareness	The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Awareness subscale is 0 to 16 where higher scores indicate more awareness.	Baseline, week 4, and 3 month follow up
Healthy Minds Index (HM Index) - Connection	The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Connection subscale range from 0 to 24, where higher scores indicate more connection.	Baseline, week 4, and 3 month follow up
Healthy Minds Index (HM Index) - Insight	The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Insight subscale range from 0 to 12, where higher scores indicate more insight.	Baseline, week 4, and 3 month follow up
Healthy Minds Index (HM Index) - Purpose	The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Purpose subscale range from 0 to 16, where higher scores indicate more purpose.	Baseline, week 4, and 3 month follow up
Life Orientation Test - Revised	The Life Orientation Test - Revised is a 6-item scale where participants report their level of optimism (e.g., "In uncertain times, I usually expect the best"). It is scored on a 5-point Likert scale where 0 = "strongly disagree" to 4 = "strongly agree." Total scores range from 0 to 24 where higher scores indicate greater optimism.	Baseline, week 4, and 3 month follow up
Perceived Stress Scale	The Perceived Stress Scale is a 10-item scale where participants report their level of perceived stress (e.g., "In the last month, how often have you felt nervous and 'stressed'?"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "very often." Total scores range from 0 to 40 where higher scores indicate greater perceived stress.	Baseline, week 4, and 3 month follow up
Perseverative Thinking Questionnaire	The Perseverative Thinking Questionnaire is a 15-item scale where participants report their level of repetitive negative thinking (e.g., "My thoughts repeat themselves"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "almost always." Total scores range from 0 to 60 where higher scores indicate greater perseverative thinking.	Baseline, week 4, and 3 month follow up
Satisfaction With Life Scale	The Satisfaction with Life Scale is a 5-item scale where participants report their level of satisfaction with life (e.g., "In most ways my life is close to ideal"). It is scored on a 7-point Likert scale where 1 = "strongly disagree" to 7 = "strongly agree." Total scores range from 5 to 35 where higher scores indicate greater satisfaction with life.	Baseline, week 4, and 3 month follow up
Subjective Happiness Scale	The Subjective Happiness Scale is a 4-item scale where participants report their level of subjective happiness (e.g., "In general, I consider myself [not a very happy person, a very happy person]"). It is scored on a 7-point Likert scale where 1 = less happy to 7 = more happy. Total scores range from 4 to 28 where higher scores indicate greater subjective happiness.	Baseline, week 4, and 3 month follow up
Problematic and Risky Internet Use Screening Scale (PRIUSS-3)	The PRIUSS-3 is a 3-item scale where participants report their level of problematic internet use. It is scored on a 4-point Likert scale where 0 = never to 4 = very often. Total scores range from 0 to 12, where higher scores indicate more problematic internet use.	Baseline, week 4, and 3 month follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindfulness Adherence Questionnaire	The Mindfulness Adherence Questionnaire informal practice items are 6-items assessing the application of mindfulness during daily life (e.g., "In your daily life, how much of the time were you practicing being gentle and compassionate toward yourself?"). It is scored on a 7-point Likert scale where 0 = "never" to 6 = "always." Total scores range from 0 to 42 where higher scores indicate greater informal mindfulness practice.	week 1, week 2, week 3, week 4, and 3 month follow up
Inflammatory Biomarkers: C-reactive Protein (CRP)	Dried blood spot samples will be used to measure two inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from ~200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1).	Baseline and 3 month follow-up
Inflammatory Biomarkers: TNF-Alpha, IL-6, Il-10	Dried blood spot samples will be used to measure two inflammatory cytokines (C-reactive protein (CRP) and interleukin-6 (IL-6)). Additionally mRNA assays will be used to detect and quantify inflammatory gene expression detect and monitor cellular immune responses. Analyses will focus on transcripts from ~200 genes known to be involved in the regulation of inflammation, and will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1).	Baseline and 3 month follow-up
Microbiome Alpha Diversity: Species Richness	Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Reported here are the observed (total number of distinct taxa) and calculated (Chao1 = N + S2 / (2 D), where N is the number of observed OTUs (Operational Taxonomic Units), S is the number of singleton OTUs, and D is the number of doublet OTUs) number of species represented in the sample. Chao1 is a species richness calculator that accounts for rare species.	Baseline and 3 month follow-up
Microbiome Alpha Diversity: Shannon Diversity Index (H')	Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Shannon Diversity Index quantifies both the richness and the evenness of a community. It takes into account the number of taxa (richness) and their relative abundances (evenness). A higher Shannon index value indicates greater diversity, with both a high number of taxa and more even distribution of abundances among them. It is often used to assess the balance between species in a community. Typically ranges from 0-5 with higher numbers indicating increasing species diversity.	Baseline and 3 month follow-up
Microbiome Alpha Diversity: Inverse Simpson (1/D)	Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Simpson is the probability that any two microbes are the same species, ranging from 0-1. Inverse Simpson (1 / Simpson) considers both richness and evenness. It places greater weight on the more abundant taxa. A higher inverse Simpson index suggests a more even distribution of taxa, with fewer dominant species. The inverse Simpson index is sensitive to the presence of dominant species and may emphasize diversity loss when one or a few species dominate the community.	Baseline and 3 month follow-up
Microbiome Alpha Diversity: Pielou Evenness Index (J)	Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Pielou Evenness Index measures how evenly the individuals are distributed across the taxa in a sample. It is calculated by dividing the Shannon diversity index by the maximum possible value of the Shannon index (which occurs when all taxa are equally abundant). The Pielou index ranges from 0 (no evenness, where one species dominates) to 1 (perfect evenness, where all species are equally abundant).	Baseline and 3 month follow-up
Microbiome Alpha Diversity: Simpson's Dominance Index (D)	Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. Simpson's Dominance Index measures the probability that two randomly selected individuals from a community belong to the same species (or taxon). It ranges from 0 to 1, where 0 indicates perfect diversity (no dominance of a single species) and values closer to 1 indicate that one or a few species dominate the community. A lower Simpson's dominance score suggests a more diverse community, while a higher score indicates a community dominated by a few taxa.	Baseline and 3 month follow-up
Facial Behavior: Cheek Raise Score	Participants provide video recordings of their face while responding to a prompt watching brief videos of positive valence (e.g., baby giggling). Data are reported in Action Unit 6 (AU6) of Facial Action Coding System (FACS). FACS is an anatomically-based system for describing facial movement, breaking facial expressions into individual muscle movements called Action Units (AUs). The scores indicate the intensity of cheek movement (0-100), higher movements indicate more intense movement.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Lure Discrimination Task (LDI)	Meditation training has the capacity to normalize the overgeneralized inflexible cognition endemic to depression, which is hypothesized to relate to alterations in the hippocampal-dependent process of pattern separation. The investigators will use a pattern separation task to evaluate hippocampal function. The Lure Discrimination Task (LDI) is the difference between the probability of giving a "Similar" response to the lure items (similar to target items) minus the probability of giving a "Similar" response to the foils (unrelated to target items). Larger differences indicate increased discrimination.	Baseline, week 4 (of intervention period), and 3 month follow-up
Self-Referential Pronoun Use	Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore indicators of self-referent, inflexible, & over-generalized thinking within natural language. Reported here is the "I" self-referential word frequency.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Negative Affect Word Use: Negative Sentiment	Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore negative affect word use. Data are reported in percentage (0-100) where higher numbers indicate more intense negative sentiment.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Negative Affect Word Use: Positive Sentiment	Participants provide recordings of their voice while responding to a prompt that asks to share information about their day. These recordings provide the opportunity to explore negative affect word use. Data are reported in percentage (0-100) where higher numbers indicate greater positive sentiment.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Treatment Expectancies	The Treatment Expectancies is a 6-item scale assessing how much participants believed the training program was helpful to them. Items assess how participants think (e.g., "At this point, how logical does the program offered to you seem?") and feel (e.g., "At this point, how much do you really feel that the program helped you to reduce your stress symptoms?"). Items are scored on either a 9-point Likert scale (e.g., 1 = "not at all logical" to 9 = "very logical") or on a percentage ("At the end of the program, how much improvement in your symptoms do you really feel occurred?", 0% to 100%). Higher scores reflect higher treatment expectancies.	3-month follow-up
Number of Participants With PHQ-8 Scores That Increased by 5 Points or More Compared to Baseline	The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. Increase in scores indicates increase is depression symptoms.	Week 1, Week 2, Week 3, Week 4, 3-month follow-up
Digital Working Alliance Inventory	The Digital Working Alliance Inventory is a 6-item scale where participants report their working alliance with the HMP app (e.g., "The HMP app supports me to overcome challenges"). It is scored on a 7-point Likert scale where 1 = "strongly disagree" to 7 = "strongly agree." Total scores range from 6 to 42 where higher scores indicate greater working alliance.	week 1, week 2, week 3, week 4, and 3-month follow-up
Inclusion of Nature in Self	The Inclusion of Nature in Self is a single item measure assessing the degree to which someone views nature as a part of their sense of self. Participants indicate which of a series of overlapping circles most closely resembles nature and their self. More overlapping circles indicate greater inclusion of nature in self.	Baseline, week 4 (of intervention period), and 3 month follow-up
Change in Pre- and Post-practice Positive Affect	Two items assessing positive affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. Data comes from multiple surveys.	Before and after HMP activities week 1, week 2, week 2, and week 4
Change in Pre- and Post-practice Negative Affect	Two items assessing negative affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much. Data comes from multiple surveys.	Before and after HMP activities week 1, week 2, week 2, and week 4
Change in Post-practice Focus	A single item assessing focus during HMP activities is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = most of the time. Data comes from multiple surveys.	Before and after HMP activities week 1, week 2, week 2, and week 4

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Hope for Depression Research Foundation
• Investigators: Principal Investigator: Simon Goldberg, PhD, UW-Madison, Center for Healthy Minds

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Actual): July 15, 2024
• Study Completion (Actual): July 15, 2024

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: 2021-0991; A487400 (Other Identifier: UW Madison); 1U24AT011289-01 (U.S. NIH Grant/Contract); Protocol Version 6/29/2023 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No