Behavior, Biology and Well-Being Study

Depression Clinical Trial

— BeWell  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06213701
• Other study ID #: 2021-0991: Pilot
• Secondary ID: Protocol Version
• Status: Completed
• Phase: N/A
• Start date: June 16, 2022
• Est. completion date: July 15, 2023

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The central aim of this pilot study is to compare markers of inflammation and gut microbial diversity with users 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 300 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.

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.

Specific Aims:

• Aim 1. Determine the feasibility and acceptability of assessing inflammatory activity and gut microbiome within the context of a fully remote randomized controlled trial (RCT). Participants with elevated depression symptoms from an RCT (n = 1,100; registered to NCT05183867) comparing the Healthy Minds Program (HMP) app with an active control (HMP with didactic content only) and wait-list will be invited to provide dried blood spots (DBS) for inflammatory protein analysis and fecal samples for gut microbial analysis at baseline and 3-month follow-up. Hypotheses: It will be feasible to recruit 300 participants to provide DBS and fecal samples and 80% will provide samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.

• Aim 2. Characterize the association between self-reports of well-being, inflammatory activity at baseline, and microbiota diversity at baseline. Hypotheses: Well-being will correlate inversely with both protein biomarkers of inflammation (CRP, IL-6) and mRNA-derived indicators of pro-inflammatory transcriptional activity. Well-being will correlate positively with alpha diversity of the gut microbiome. These associations will not be moderated by participant race/ethnicity.

• Aim 3. Evaluate intervention effects on inflammatory activity and microbiota diversity. Hypotheses: Participants randomized to HMP or the active control will show larger reductions in inflammation vs. wait-list at 3-month follow-up and larger increases in alpha diversity of the gut microbiome vs. wait-list at 3-month follow-up. HMP will show larger reductions in inflammation vs. active control at 3-month follow-up and larger increases in alpha diversity vs. active control at 3-month follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Psychological Distress

Intervention

Device:
• Healthy Minds Program
HMP is a 4-week mobile health (mHealth) meditation training program.

Other:
• Psychoeducation app
Psychoeducation app

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Hope for Depression Research Foundation, National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of DBS Collection as measured by Number of Participants who Provide DBS	Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.	Baseline and 3 month follow-up
Primary	Feasibility of Fecal Sample Collection as measured by Number of Participants who Provide Fecal Samples	Feasibility is defined as 80% of participants providing samples at both time points (completer n = 240) with no differences in completion rates between non-Hispanic White and racial/ethnic minority participants.	Baseline and 3 month follow-up
Secondary	Change in Microbiome Alpha Diversity	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.	Baseline and 3 month follow-up
Secondary	Change in Inflammatory Biomarkers	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
Secondary	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.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Secondary	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.	Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up

External Links

•   FULL Behavior, Biology and Well-Being Study