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StressNCT05215314

Brain and Meditation (BAM) Study

A study testing mHealth Meditation in people with Stress and Behavior, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 25 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Stress, Behavior
What is being tested?
mHealth Meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
13 Apr 2022to 9 Jan 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Healthy Minds

    Madison, Wisconsin, 53703

Other trials in United States

About this study

Official title: Neurobiological Mechanisms of Perceived Stress and Their Modification Through Behavioral Intervention

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.

Read the detailed description

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.

Conditions
Stress, Behavior
Being tested
mHealth Meditation
Keywords
healthy minds program, mobile health
Medical subject headings
Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealth MeditationBehavioural

    Also called mobile health app

    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.

Study groups in NCT05215314
Study groupRoleWhat they receive
Healthy Minds Program (HMP)ExperimentalFully remote, 4-week meditation intervention
Receives: Behavioral: mHealth Meditation
Waitlist ControlNo interventionControl participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Perceived Stress Scale (PSS) Score

    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.

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

Secondary outcomes (3)

  1. Change in Behavioral Pattern Separation Task

    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.

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

  2. Change in PROMIS Depression Score

    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).

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

  3. Change in PROMIS Anxiety Score

    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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2022
  2. Study start13 Apr 2022
  3. Primary completion9 Jan 2024
  4. Study completion9 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05215314
Sponsor's protocol ID
2021-1109
Other IDs
Protocol Version 10/12/2022, A483000, 5K01MH117222
Status last verified
Jan 2025
First submitted
18 Jan 2022
Last updated
6 Feb 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigators may share coded data with researchers to address future research questions not included in this application, with a complementary study being conducted at the Center for Healthy Minds which is utilizing many of the same survey and behavioral task measures, and/or with journals where open data sharing policies are encouraged or are a requirement for publication. Coded data may be shared as Supplemental Information uploaded to journal websites. The investigators may share fully de-identified data from the study on data sharing platforms (e.g., OSF, NIMH Data Archive) for use by non-collaborators. Data shared on data sharing platforms will be uploaded via the internet. Confidentiality will be protected by stripping the data of all identifiers, including HIPAA identifiers.

Publications

  • Heller AS, Shi TC, Ezie CEC, Reneau TR, Baez LM, Gibbons CJ, Hartley CA. Association between real-world experiential diversity and positive affect relates to hippocampal-striatal functional connectivity. Nat Neurosci. 2020 Jul;23(7):800-804. doi: 10.1038/s41593-020-0636-4. Epub 2020 May 18.

    PubMed 32424287

Questions about this trial

What is this clinical trial studying?

A study testing mHealth Meditation in people with Stress and Behavior, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05215314, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.

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