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Behavior, Biology and Well-Being Study (BeWell)

Primary Purpose

Depression, Psychological Distress

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Healthy Minds Program

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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 or any answer other than "not at all" on item 9 of the PHQ-9)
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

Sites / Locations

University of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Healthy Minds Program (HMP) app

Psychoeducation app

Usual Care

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Change in 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.

Secondary Outcome Measures

Change in 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.

Change in 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.

Change in 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.

Change in 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.

Change in 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.

Change in 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.

Change in 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.

Change in 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

Change in 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.

Change in 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.

Change in 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.

Change in 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.

Change in Healthy Minds Index (HM Index)

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 four subscales range as follows: Awareness (0 to 16), Connection (0 to 24), Insight (0 to 12), Purpose (0 to 16) where higher scores indicate more of each quality.

Change in 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.

Change in 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.

Change in 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.

Change in 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.

Change in 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.

Change in 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.

Full Information

NCT ID

NCT05183867

First Posted

December 21, 2021

Last Updated

September 18, 2023

Sponsor

University of Wisconsin, Madison

Collaborators

Hope for Depression Research Foundation, National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT05183867

Brief Title

Behavior, Biology and Well-Being Study

Acronym

BeWell

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 24, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

Collaborators

Hope for Depression Research Foundation, National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Psychological Distress

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The groups will be randomized to one of three groups in a 2:2:1 ratio.

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy Minds Program (HMP) app

Arm Type

Experimental

Arm Description

Arm Title

Psychoeducation app

Arm Type

Active Comparator

Arm Description

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Healthy Minds Program

Other Intervention Name(s)

HMP

Intervention Description

HMP is a 4-week mobile health (mHealth) meditation training program.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

Title

Change in Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score

Description

Time Frame

Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

Title

Change in Flourishing Measured by the Flourishing Index Score

Description

Time Frame

Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

Title

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

Description

Time Frame

Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

Title

Change in Connection Measured by NIH Toolbox Loneliness Score

Description

Time Frame

Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

Title

Change in Decentering Measured by Decentering Subscale of Experiencing Questionnaire scale score

Description

Time Frame

Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

Title

Change in Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score

Description

Time Frame

Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

Title

Change in Pain Intensity measured by PROMIS Pain Intensity score

Description

Time Frame

Baseline, week 4 (of intervention period), and 3 month follow-up

Title

Change in Pain Interference measured by PROMIS Pain Inference Scale Score

Description

Time Frame

Baseline, week 4 (of intervention period), and 3 month follow-up

Title

Change in Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score

Description

Time Frame

Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

Title

Change in Climate Change Anxiety Scale

Description

Time Frame

Baseline, week 4, and 3 month follow up

Title

Change in Wellbeing Growth Mindset

Description

Time Frame

Baseline, week 4, and 3 month follow up

Title

Change in Healthy Minds Index (HM Index)

Description

Time Frame

Baseline, week 4, and 3 month follow up

Title

Change in Life Orientation Test - Revised

Description

Time Frame

Baseline, week 4, and 3 month follow up

Title

Change in Perceived Stress Scale

Description

Time Frame

Baseline, week 4, and 3 month follow up

Title

Change in Perseverative Thinking Questionnaire

Description

Time Frame

Baseline, week 4, and 3 month follow up

Title

Change in Satisfaction with Life Scale

Description

Time Frame

Baseline, week 4, and 3 month follow up

Title

Change in Subjective Happiness Scale

Description

Time Frame

Baseline, week 4, and 3 month follow up

Title

Change in Problematic and Risky Internet Use Screening Scale (PRIUSS-3)

Description

Time Frame

Baseline, week 4, and 3 month follow up

Other Pre-specified Outcome Measures:

Title

Change in Inflammatory Biomarkers

Description

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).

Time Frame

Baseline and 3 month follow-up

Title

Change in Microbiome Alpha Diversity

Description

Genetic analyses of the microbiome of the fecal sample (microorganism DNA, not that of the person) will be performed. DNA extraction of the fecal community of microorganisms will provide the sequencing data to do alpha and beta diversity analysis and phenotypic cluster assessments.

Time Frame

Baseline and 3 month follow-up

Title

Change in Facial Behavior

Description

Participants provide video recordings of their face while responding to a prompt watching brief videos of positive valence (e.g., baby giggling).

Time Frame

Baseline, week 4 (of intervention period), and 3 month follow-up

Title

Change in Pattern Separation Task

Description

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.

Time Frame

Baseline, week 4 (of intervention period), and 3 month follow-up

Title

Change in Self-Referential Pronoun Use

Description

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.

Time Frame

Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

Title

Change in Negative Affect Word Use

Description

Time Frame

Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

Title

Change in Digital Working Alliance Inventory

Description

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.

Time Frame

week 1, week 2, week 3, week 4, and 3-month follow-up

Title

Change in Inclusion of Nature in Self

Description

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.

Time Frame

Baseline, week 4 (of intervention period), and 3 month follow-up

Title

Mindfulness Adherence Questionnaire

Description

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.

Time Frame

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

Title

Change in pre- and post-practice positive affect

Description

Two items assessing positive affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.

Time Frame

Before and after HMP activities between baseline and post-test (week 4)

Title

Change in pre- and post-practice negative affect

Description

Two items assessing negative affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.

Time Frame

Before and after HMP activities between baseline and post-test (week 4)

Title

Change in post-practice focus

Description

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.

Time Frame

Before and after Before and after HMP activities between baseline and post-test (week 4)

Title

Treatment Expectancies

Description

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.

Time Frame

week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Simon Goldberg, PhD

Phone

608-265-8986

sbgoldberg@wisc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simon Goldberg, PhD

Organizational Affiliation

UW-Madison, Center for Healthy Minds

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53703

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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