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Behavioral Intervention
Brain and Meditation (BAM) Study
N/A
Waitlist Available
Led By Dan Grupe, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if an app-based meditation program can help reduce stress and its behavioral effects.
Who is the study for?
The BAM Study is for US citizens or permanent residents aged 25-65 who can understand English and are able to give informed consent. Participants must have a smartphone to download an app but should not be experienced in meditation practices, nor have current psychopathology that could affect participation.
What is being tested?
This study tests an app-based meditation program's effect on stress and behavior over 4-5 months. It's a randomized controlled trial, meaning people will be randomly assigned to either use the meditation program or not, to compare outcomes.
What are the potential side effects?
Since this trial involves mHealth Meditation via an app, there aren't typical medical side effects; however, participants may experience changes in mood or stress levels due to engaging with the meditation practices.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, following week 1, week 2, week 3, week 4 of intervention period, and 3 month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Perceived Stress Scale (PSS) Score
Secondary study objectives
Change in Behavioral Pattern Separation Task
Change in PROMIS Anxiety Score
Change in PROMIS Depression Score
Other study objectives
Change in Five-facet Mindfulness Questionnaire: Awareness Subscale (FFMQ-A8) Score
Change in Healthy Minds Index (HMI) Score
Change in NIH toolbox Loneliness Score
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Healthy Minds Program (HMP)Experimental Treatment1 Intervention
Fully remote, 4-week meditation intervention
Group II: Waitlist ControlActive Control1 Intervention
Control participants will not complete the Healthy Minds Program during the study, but can use it after they have completed the study
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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,223 Previous Clinical Trials
3,167,978 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,894 Previous Clinical Trials
2,731,615 Total Patients Enrolled
Dan Grupe, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been regularly practicing meditation for the past 6 months or have attended a meditation or yoga retreat with a focus on meditation. Or, you have previously used the Healthy Minds Program app to a significant extent.You have access to a smartphone that can download apps from Google Play or the Apple App Store.You have a history of episodes of mania.You are willing and able to complete all study procedures, including the Healthy Minds Program.You have a mental health condition that could make it difficult for you to complete the study.You have a history of mental illness that caused you to lose touch with reality.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Minds Program (HMP)
- Group 2: Waitlist Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Stress Patient Testimony for trial: Trial Name: NCT05215314 — N/A
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