Brain and Meditation (BAM) Study

Stress Clinical Trial

Official title:

Neurobiological Mechanisms of Perceived Stress and Their Modification Through Behavioral Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05215314
• Other study ID #: 2021-1109
• Secondary ID: Protocol Version
• Status: Completed
• Phase: N/A
• Start date: April 13, 2022
• Est. completion date: January 9, 2024

Study information

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

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 9, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior
• Stress

Intervention

Behavioral:
• mHealth Meditation
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.

Locations

Country	Name	City	State
United States	Center for Healthy Minds	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Posttraumatic Stress Disorder Checklist (PCL-5) Score	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.	Baseline, following week 4 of intervention period, and 3 month follow-up
Other	Change in PROMIS Sleep Disturbance Score	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.	Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up
Other	Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) Score	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.	Baseline, following week 4 of intervention period, and 3 month follow-up
Other	Change in NIH toolbox Loneliness Score	NIH toolbox Loneliness is a 5-item survey scored on a 5 point likert scale for a total possible range of scores from 5-25 where higher scores indicate increased loneliness.	Baseline, following week 4 of intervention period, and 3 month follow-up
Other	Change in Healthy Minds Index (HMI) Score	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.	Baseline and following week 4 of intervention period
Other	Change in roaming entropy	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)	Exploratory analyses will examine linear and nonlinear trajectories of change from baseline through 3-month follow-up
Primary	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.	Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up
Secondary	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 pattern separation index is calculated as the proportion of lures correctly differentiated as "similar".	Baseline, following week 4 of intervention period, and 3 month follow-up
Secondary	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.	Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up
Secondary	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.	Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up