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Completed

NCT Number: NCT05215314

Brain and Meditation (BAM) Study

This study is a randomized controlled trial to test the impact of an app-based meditation program on perceived stress and behavioral correlates of stress with known neurobiological correlates. Healthy adult participants between the ages of 25-65 will be enrolled in the study for about 4-5 months.

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Key information

Conditions

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Healthy Minds

Madison, Wisconsin, 53703, United States

About this study

Participants will be randomized into one of two groups: the intervention group or the waitlist control group. The intervention group will use a mobile health app for four weeks. Participants will complete pre-intervention, weekly, post-intervention, and 3-month follow-up surveys and tasks.

Primary Objective: Test for hypothesized group differences in perceived stress during participation in a 4-week meditation program and at 3-month follow-up.

Secondary Objective: Within the meditation group, determine whether reductions in perceived stress are associated with changes in hippocampal-dependent behavior.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individual can read, write, speak, and understand English
  • Able to provide informed consent
  • Willing and able to complete all study procedures, including the Healthy Minds Program
  • Has access to a smartphone that can download apps from Google Play or the Apple App Store
  • US citizen or a permanent US resident (green card holder)

Exclusion criteria

  • Extensive experience in meditation practice (e.g., regular daily meditation practice for the past 6 months or regular weekly meditation practice for the past 12 months), experience in substantively similar meditation training programs (e.g., attended a meditation retreat or a yoga/body practice retreat with a significant mediation component), or substantial previous use of the Healthy Minds Program app
  • Individuals will be excluded if they previously participated in substantively similar research at our Center at the discretion of the investigator due to similar tasks being used in certain studies
  • History of psychosis
  • History of mania
  • Current psychopathology that interferes with study participation

Treatment and study plan

mHealth Meditation

Behavioral

Participants will receive access to the 4-week Healthy Minds Program (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.

Other names: mobile health app

Primary outcomes

  1. Change in Perceived Stress Scale (PSS) Score

    Time frame: Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up

    PSS is a 10-item survey scored on a 5 point likert scale from 0 = never to 4 = very often, for a total possible range of scores from 0-40 where higher scores indicate higher perceived stress.

Secondary outcomes

  1. Change in Behavioral Pattern Separation Task

    Time frame: Baseline, following week 4 of intervention period, and 3 month follow-up

    Participants will complete a behavioral pattern separation task . During this task, participants will encode pictures of common objects while performing a basic categorization task. Participants will then label pictures as "Old" (targets, identical objects to those in the encoding phase), "New" (foils, or completely novel objects), or "Similar" (lure items, distinct exemplars of objects seen during encoding). The measure of interest on this task is the "Lure Discrimination Index", which is calculated as the proportion of lures correctly identified as "similar" minus the proportion of foils that are incorrectly identified as "similar". The theoretical range for the pattern separation index is [-1,1], with higher scores indicating better performance.

  2. Change in PROMIS Depression Score

    Time frame: Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up

    The PROMIS Depression Score is a measure of feelings of depression in the past 7 days. This is a computer-adaptive survey scored on a 5 point likert scale from 1 (never) to 5 (always) with higher scores indicating increased depression. For analysis, total scores will be converted to t scores with a mean of 50 and SD of 10. Higher t scores indicate higher levels of depression. A t score >= 59.9 is indicative of moderate depression, a t score >= 65.8 is indicative of moderately severe depression, and a t score >= 71.5 is indicative of severe depression (based on corresponding cutoffs on the Patient Health Questionnaire-9).

  3. Change in PROMIS Anxiety Score

    Time frame: Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up

    The PROMIS Anxiety Score is a measure of feelings of anxiety in the past 7 days. This is a computer-adaptive survey scored on a 5 point likert scale from 1 (never) to 5 (always) with higher scores indicating increased anxiety. For analysis, total scores will be converted to t scores with a mean of 50 and SD of 10. Higher t scores indicate higher levels of anxiety. A t score >= 62.3 is indicative of moderate anxiety and a t score >= 67.7 is indicative of severe anxiety (based on corresponding cutoffs on the General Anxiety Disorder-7).

Other outcomes

  1. Change in Posttraumatic Stress Disorder Checklist (PCL-5) Score

    Time frame: Baseline, following week 4 of intervention period, and 3 month follow-up

    The PCL-5 is a 20-item survey scored on a 5 point likert scale from 0 (not at all) to 4 (extremely) for a total possible range of score from 0-80 where higher scores indicate more symptoms of PTSD within the last 30 days.

  2. Change in PROMIS Sleep Disturbance Score

    Time frame: Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up

    The PROMIS Sleep Disturbance Score is a measure of sleep in the past 7 days. This is a computer-adaptive survey scored on a 5 point likert scale with higher scores indicating increased sleep disturbance. For analysis, total scores will be converted to t scores with a mean of 50 and SD of 10. Higher t scores indicate higher levels of sleep disturbances. A t score >= 45.1 is indicative of significant sleep disturbances (based on a corresponding cutoff of >= 5 on the Pittsburgh Sleep Quality Index).

  3. Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) Score

    Time frame: Baseline, following week 4 of intervention period, and 3 month follow-up

    The FFMQ-A8 is an 8-item survey scored on a 5 point likert scale from 'never, or very rarely true' to 'very often or always true', for a total possible range of scores from 8-40 where higher scores indicate greater mindfulness awareness.

  4. Change in NIH Toolbox Loneliness Score

    Time frame: Baseline, following week 4 of intervention period, and 3 month follow-up

    NIH toolbox Loneliness is a 5-item survey scored on a 5 point likert scale. The average score is taken across items for a total possible range of scores from 1-5, where higher scores indicate increased loneliness.

  5. Change in Healthy Minds Index (HMI) Score

    Time frame: Baseline and following week 4 of intervention period

    HMI is a 17-item survey scored on a 5 point likert scale from 0 (never, none, not at all) to 4 (always, every time, to the highest degree) that assesses awareness, connection, insight, and purpose. Higher scores indicate higher sense of awareness, connection, insight, and purpose. Mean score for each subscale will be reported.

  6. Change in Roaming Entropy

    Time frame: Exploratory analyses will examine linear and nonlinear trajectories of change from baseline through 3-month follow-up

    Roaming entropy will be calculated according to the formula in Heller et al. (2020). Using continuous GPS location tracking, the measure takes into account distance traveled and distinct locations visited, with a single resulting value reflecting the diversity of movement through one's lived environment (Measured continuously throughout study participation)

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Neurobiological Mechanisms of Perceived Stress and Their Modification Through Behavioral Intervention

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2022
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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