Trial Outcomes & Findings for Brain and Meditation (BAM) Study (NCT NCT05215314)

NCT ID: NCT05215314

Last Updated: 2025-02-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: Baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up
• Results posted on: 2025-02-06

Participant Flow

Participant milestones

Measure	Healthy Minds Program (HMP) Fully remote, 4-week meditation intervention 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.	Waitlist Control Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study
Overall Study STARTED	100	50
Overall Study COMPLETED	95	48
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Measure	Healthy Minds Program (HMP) Fully remote, 4-week meditation intervention 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.	Waitlist Control Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by Subject	2	0
Overall Study Physician Decision	1	0

Baseline Characteristics

Brain and Meditation (BAM) Study

Baseline characteristics by cohort

Measure	Healthy Minds Program (HMP) n=100 Participants Fully remote, 4-week meditation intervention	Waitlist Control n=50 Participants Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study	Total n=150 Participants Total of all reporting groups
Age, Continuous	39.9 years STANDARD_DEVIATION 10 • n=5 Participants	40.6 years STANDARD_DEVIATION 11 • n=7 Participants	40.2 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	25 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	25 Participants n=7 Participants	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	86 Participants n=5 Participants	42 Participants n=7 Participants	128 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	70 Participants n=5 Participants	27 Participants n=7 Participants	97 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	50 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

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

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

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.

Outcome measures

Measure	Healthy Minds Program (HMP) n=99 Participants Fully remote, 4-week meditation intervention	Waitlist Control n=50 Participants Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study
Change in Perceived Stress Scale (PSS) Score baseline	15.0 score on a scale Standard Deviation 6.49	17.1 score on a scale Standard Deviation 7.42
Change in Perceived Stress Scale (PSS) Score week 1	13.5 score on a scale Standard Deviation 6.71	17.1 score on a scale Standard Deviation 7.48
Change in Perceived Stress Scale (PSS) Score week 2	13.1 score on a scale Standard Deviation 7.03	15.1 score on a scale Standard Deviation 7.94
Change in Perceived Stress Scale (PSS) Score week 3	12.5 score on a scale Standard Deviation 6.43	15.6 score on a scale Standard Deviation 6.52
Change in Perceived Stress Scale (PSS) Score week 4	13.6 score on a scale Standard Deviation 6.6	16.7 score on a scale Standard Deviation 6.91
Change in Perceived Stress Scale (PSS) Score 3 month follow up	13.8 score on a scale Standard Deviation 6.96	17.8 score on a scale Standard Deviation 6.76

SECONDARY outcome

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

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

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.

Outcome measures

Measure	Healthy Minds Program (HMP) n=94 Participants Fully remote, 4-week meditation intervention	Waitlist Control n=47 Participants Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study
Change in Behavioral Pattern Separation Task baseline	.507 Lure Discrimination Index Standard Deviation .201	.456 Lure Discrimination Index Standard Deviation .197
Change in Behavioral Pattern Separation Task week 4	.502 Lure Discrimination Index Standard Deviation .212	.489 Lure Discrimination Index Standard Deviation .179
Change in Behavioral Pattern Separation Task 3 month follow up	.542 Lure Discrimination Index Standard Deviation .169	.483 Lure Discrimination Index Standard Deviation .205

SECONDARY outcome

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

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

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).

Outcome measures

Measure	Healthy Minds Program (HMP) n=99 Participants Fully remote, 4-week meditation intervention	Waitlist Control n=50 Participants Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study
Change in PROMIS Depression Score baseline	52.4 score on a scale Standard Deviation 7.16	54.7 score on a scale Standard Deviation 7.28
Change in PROMIS Depression Score week 1	51.6 score on a scale Standard Deviation 8.17	54.8 score on a scale Standard Deviation 7.42
Change in PROMIS Depression Score week 2	51.3 score on a scale Standard Deviation 8.08	42.3 score on a scale Standard Deviation 9.28
Change in PROMIS Depression Score week 3	51.1 score on a scale Standard Deviation 8.27	55.0 score on a scale Standard Deviation 8.35
Change in PROMIS Depression Score week 4	50.2 score on a scale Standard Deviation 7.97	52.8 score on a scale Standard Deviation 8.25
Change in PROMIS Depression Score 3 month follow up	51.9 score on a scale Standard Deviation 8.44	54.4 score on a scale Standard Deviation 7.91

SECONDARY outcome

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

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

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).

Outcome measures

Measure	Healthy Minds Program (HMP) n=99 Participants Fully remote, 4-week meditation intervention	Waitlist Control n=50 Participants Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study
Change in PROMIS Anxiety Score week 1	55.3 score on a scale Standard Deviation 7.56	57.4 score on a scale Standard Deviation 8.31
Change in PROMIS Anxiety Score week 2	54.9 score on a scale Standard Deviation 8.05	55.8 score on a scale Standard Deviation 7.70
Change in PROMIS Anxiety Score baseline	55.8 score on a scale Standard Deviation 7.36	58.0 score on a scale Standard Deviation 8.46
Change in PROMIS Anxiety Score week 3	54.0 score on a scale Standard Deviation 7.95	57.4 score on a scale Standard Deviation 7.90
Change in PROMIS Anxiety Score week 4	53.1 score on a scale Standard Deviation 8.30	56.2 score on a scale Standard Deviation 8.72
Change in PROMIS Anxiety Score 3 month follow up	54.3 score on a scale Standard Deviation 8.06	57.5 score on a scale Standard Deviation 6.94

OTHER_PRE_SPECIFIED outcome

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

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

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.

Outcome measures

Measure	Healthy Minds Program (HMP) n=99 Participants Fully remote, 4-week meditation intervention	Waitlist Control n=50 Participants Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study
Change in Posttraumatic Stress Disorder Checklist (PCL-5) Score Baseline	15.6 score on a scale Standard Deviation 12.2	17.2 score on a scale Standard Deviation 13.0
Change in Posttraumatic Stress Disorder Checklist (PCL-5) Score week 4	13.2 score on a scale Standard Deviation 12.1	17.8 score on a scale Standard Deviation 16.1
Change in Posttraumatic Stress Disorder Checklist (PCL-5) Score 3-month follow-up	13.9 score on a scale Standard Deviation 12.6	20.1 score on a scale Standard Deviation 13.4

OTHER_PRE_SPECIFIED outcome

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

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

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).

Outcome measures

Measure	Healthy Minds Program (HMP) n=99 Participants Fully remote, 4-week meditation intervention	Waitlist Control n=50 Participants Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study
Change in PROMIS Sleep Disturbance Score week 3	49.8 score on a scale Standard Deviation 9.33	53.6 score on a scale Standard Deviation 8.92
Change in PROMIS Sleep Disturbance Score week 4	50.1 score on a scale Standard Deviation 9.10	53.3 score on a scale Standard Deviation 9.95
Change in PROMIS Sleep Disturbance Score Baseline	52.0 score on a scale Standard Deviation 8.12	54.4 score on a scale Standard Deviation 9.28
Change in PROMIS Sleep Disturbance Score week 1	51.3 score on a scale Standard Deviation 9.05	54.0 score on a scale Standard Deviation 9.24
Change in PROMIS Sleep Disturbance Score week 2	50.6 score on a scale Standard Deviation 8.27	52.9 score on a scale Standard Deviation 9.66
Change in PROMIS Sleep Disturbance Score 3-month follow-up	50.5 score on a scale Standard Deviation 8.60	55.1 score on a scale Standard Deviation 9.84

OTHER_PRE_SPECIFIED outcome

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

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

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.

Outcome measures

Measure	Healthy Minds Program (HMP) n=99 Participants Fully remote, 4-week meditation intervention	Waitlist Control n=50 Participants Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study
Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) Score Baseline	27.9 score on a scale Standard Deviation 6.88	27.8 score on a scale Standard Deviation 7.36
Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) Score week 4	28.3 score on a scale Standard Deviation 6.02	28.3 score on a scale Standard Deviation 7.41
Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) Score 3-month follow-up	29.1 score on a scale Standard Deviation 6.41	28.0 score on a scale Standard Deviation 7.41

OTHER_PRE_SPECIFIED outcome

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

Population: The number analyzed changes over time because not all participants provided complete data for this measure at each timepoint.

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.

Outcome measures

Measure	Healthy Minds Program (HMP) n=99 Participants Fully remote, 4-week meditation intervention	Waitlist Control n=50 Participants Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study
Change in NIH Toolbox Loneliness Score Baseline	2.44 score on a scale Standard Deviation 1.02	2.28 score on a scale Standard Deviation 0.84
Change in NIH Toolbox Loneliness Score week 4	2.17 score on a scale Standard Deviation 1.00	2.19 score on a scale Standard Deviation 0.90
Change in NIH Toolbox Loneliness Score 3-month follow-up	2.25 score on a scale Standard Deviation 1.07	2.25 score on a scale Standard Deviation 0.95

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

Adverse Events

Healthy Minds Program (HMP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Grupe

University of Wisconsin-Madison

Phone: 608-263-7572

Email: grupe@wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place