Guided Digital Mindfulness Programs for Brain Health

(BRIGHT-Mind Trial)

Overseen By Kevin Madore, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lumos Labs, Inc.

Disqualifiers: Psychiatric, Neurological, Seizures, Visual acuity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two digital programs to evaluate their potential to boost brain health, improve thinking skills, and alter brain structure. Participants will be divided into two groups: one will use only remote tools, while the other will also undergo brain imaging. The trial is suitable for English-speaking individuals aged 25 to 80 who can use computers independently and have not engaged in online brain training programs for more than two weeks in the past three years. As an unphased trial, it offers a unique opportunity to contribute to innovative research on brain health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a psychiatric or neurological condition that requires treatment, you may not be eligible to participate.

What prior data suggests that these digital programs are safe for brain health?

Research shows that digital programs like those being studied are generally safe. Digital Program 1 has improved thinking skills, especially in older adults, without major safety issues reported. However, evidence suggests that excessive screen time can cause problems like trouble focusing or emotional issues.

Studies also support Digital Program 2 for boosting brain health, finding no serious safety concerns. Researchers are exploring digital tools for their potential to aid memory and thinking problems, and they appear well-tolerated so far.

Since these digital programs don't involve medication or medical procedures, they are usually considered safe. However, consulting a healthcare provider before starting any new program is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these digital mindfulness programs because they offer a fresh approach to enhancing brain health. Unlike traditional methods, which often involve medication or in-person interventions, these programs are entirely digital and can be accessed remotely, making them more accessible and convenient for participants. Additionally, the inclusion of guided mindfulness techniques could provide unique cognitive benefits by reducing stress and improving mental focus, which are not typically the primary focus of standard treatments. This innovative approach has the potential to reach a broader audience and offer a new avenue for maintaining brain health with greater flexibility.

What evidence suggests that this trial's digital programs could be effective for brain health?

This trial will compare two guided digital mindfulness programs for brain health. Research has shown that digital technology can enhance thinking skills, particularly in older adults. Participants may receive Digital Program 1, which studies have found to improve overall thinking abilities, including memory and attention, in individuals with mild memory problems or dementia. Specifically, one study showed a noticeable positive effect on overall brain function.

Alternatively, participants may receive Digital Program 2, which also shows promise. Research has found that eight weeks of comprehensive brain training improved thinking skills, mood, and physical ability. Both programs support brain health by enhancing thinking skills and may offer additional mental and physical benefits. ^{1 4 6 7 8}

Who Is on the Research Team?

Kevin Madore, PhD

Principal Investigator

Lumos Labs, Inc.

Are You a Good Fit for This Trial?

This trial is for adults aged 25-80 who can use a computer with internet and video conferencing tools, understand English, and follow instructions. They must be able to see well enough (with glasses if needed) to work on a computer but cannot have had seizures or significant tics, severe mental health conditions, neurological disorders like Alzheimer's or Parkinson's, or any recent medical condition that could affect the study results. They should live independently and not be pregnant.

Inclusion Criteria

Ability to comply with all the testing and study requirements, including the ability to independently use a video conferencing tool and a computer to access the web

I am between 25 and 80 years old.

I can use a computer and the internet daily by myself.

Exclusion Criteria

Any other medical condition in the last 90 days that may confound study data/assessments

I have needed help with daily activities for the last 90 days.

Current, controlled or uncontrolled psychiatric diagnosis including posttraumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, attention-deficit/hyperactivity disorder, or other symptomatic manifestations that may confound study data/assessments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in digital programs for mental stimulation and cognitive improvement

12 weeks

Remote participation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Program 1
• Digital Program 2

Trial Overview The study tests two digital programs designed to stimulate the mind. It aims to improve thinking skills and measure changes in brain structure and function through daily online activities participants complete at home using their own computers.

How Is the Trial Designed?

Group I: Cohort B Experimental Treatment 2 Interventions

Remote + Imaging subjects

Group II: Cohort A Experimental Treatment 2 Interventions

Remote-Only subjects

Who Is Running the Clinical Trial?

Lumos Labs, Inc.

Lead Sponsor

Trials

15

Recruited

16,200+

Published Research Related to This Trial

Mindfulness meditation (MM) can have side effects, particularly related to mental health, physical health, and spiritual well-being, highlighting the need for safety considerations in research.

The paper provides practical tools for researchers, including screening procedures to assess participant contraindications and guidelines for MM training, based on a review of 17 primary studies and 5 secondary reports on meditation side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. Lustyk, MK., Chawla, N., Nolan, RS., et al.[2022]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

Mindfulness-Based Cognitive Therapy (MMB) significantly reduced suicidal ideation in patients with a history of suicide attempts or current suicidal thoughts, showing a moderate effect size in a study of 109 participants.

MMB also contributed to a decrease in overall depression severity among this high-risk group, suggesting that digital interventions can effectively support traditional depression care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of online Mindfulness-Based Cognitive Therapy on suicidal ideation: A secondary analysis of a randomized trial of Mindful Mood Balance. Dimidjian, S., Kaufman, J., Coleman, N., et al.[2022]

A systematic review of ten studies on technology-based mindfulness interventions found significant clinical effects on stress, depression, and anxiety, with large effect sizes reported for stress (d = 1.57) and depression (d = 0.95).

Despite promising results, the studies had methodological limitations such as selection bias and lack of control groups, indicating that further research is needed to refine these interventions and establish their effectiveness more reliably.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Interventions Delivered by Technology Without Facilitator Involvement: What Research Exists and What Are the Clinical Outcomes? Fish, J., Brimson, J., Lynch, S.[2022]

In a study of 28 patients with chronic pain, an 8-week mindfulness-based pain management program (MBPM) improved mental health and perceived control over pain, but did not significantly reduce clinical or experimental pain ratings.

The improvements in mental health were linked to increased brain activity in areas responsible for cognitive control and emotional regulation during pain anticipation, suggesting that better emotional regulation may enhance the perception of control over pain rather than directly reducing pain intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychobiological correlates of improved mental health in patients with musculoskeletal pain after a mindfulness-based pain management program. Brown, CA., Jones, AK.[2022]

While mindfulness-based programs (MBPs) are known for their benefits, the potential for harm has not been thoroughly investigated, indicating a need for more research in this area.

The study identifies three key factors that may contribute to harm in MBPs: program-related factors, participant-related factors, and clinician-related factors, suggesting that understanding these can help improve safety and effectiveness in future mindfulness practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doing no harm in mindfulness-based programs: Conceptual issues and empirical findings. Baer, R., Crane, C., Miller, E., et al.[2023]

A study involving 2155 participants found that Mindfulness-Based Stress Reduction (MBSR) does not increase rates of harm compared to a waitlist control group, indicating its safety as a stress-reduction method.

MBSR may actually protect against various psychological and physical symptoms, suggesting it could be beneficial for mental health rather than harmful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of harm in mindfulness-based stress reduction. Hirshberg, MJ., Goldberg, SB., Rosenkranz, M., et al.[2023]

A survey of 129 stakeholders across 20 healthcare regions in Sweden revealed that while Mindfulness-Based Programs (MBPs) are being implemented, there is significant variation in the models used and modifications to evidence-based practices.

Key factors for successful MBP implementation include having a supportive leader and a champion for the program, while challenges such as time constraints and funding shortages hinder effective rollout.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implementation of Mindfulness-Based Programs in the Swedish Healthcare System - A Survey Study of Service Providers. Niemi, M., Crane, R., Sinselmeijer, J., et al.[2022]

In a 21-day mindfulness-based intervention with 82 participants, 87% reported at least one momentary adverse effect during meditation, primarily anxiety, indicating that mindfulness practice can sometimes lead to temporary increases in anxiety.

Despite these momentary effects, 25% of participants experienced sustained adverse effects in daily life after the intervention, but these were not linked to the momentary effects during meditation, suggesting that increased awareness of internal states may contribute to these post-intervention challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. Aizik-Reebs, A., Shoham, A., Bernstein, A.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11872853/

The effectiveness of digital technology interventions for ... This study supported the effectiveness of DTIs in improving cognitive function in older adults aged 60 years old and over.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05818423

Brain Health Together: A Live-Streaming Group-Based ... Preliminary results suggest that Moving TogetherTM program is associated with significant improvements in cognitive function, physical function, social ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178125000757

Efficacy of Digital Therapeutic Applications for Cognitive ... Overall, the DTx may be effective in improving cognitive and other functioning outcomes in older adults with MCI or dementia. Introduction.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12537419/

The effectiveness of digital cognitive intervention in patients ... The results showed that both types of interventions significantly improved global cognitive function (SMD: 0.64, 95% CI: 0.44 to 0.85, I2 = 0%), ...

5. mdpi.com mdpi.com/2308-3417/9/2/37

Neurocognitive Effects of an Online Brain Health Program ... In a study comparing digital health coaching to digital health education in 216 individuals at risk for Alzheimer's Disease, it was found that ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2274580725000780

Brain health PRO/Santé cerveau PRO: The development of ... The Brain Health PRO/Santé Cerveau PRO is a web-based 45-week program available in French and English. It provides general information and guidance on seven ...

7. nature.com nature.com/articles/s41591-024-03475-9

and smartphone-based remote assessment of brain health ... The study objectives were to classify mild cognitive impairment (MCI), characterize cognitive trajectories and develop tools to detect and track cognitive ...

8. tandfonline.com tandfonline.com/doi/full/10.31887/DCNS.2020.22.2/gsmall

Brain health consequences of digital technology use Potential harmful effects of extensive screen time and technology use include heightened attention-deficit symptoms, impaired emotional and ...