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

816 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two computer programs designed to stimulate the brain. The programs aim to improve thinking skills and potentially change how the brain works. The study focuses on people who want to boost their mental abilities.

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 data supports the effectiveness of the treatment Digital Program 1 and Digital Program 2 in the clinical trial Guided Digital Mindfulness Programs for Brain Health?

Research shows that digital mindfulness programs can help reduce stress, depression, and anxiety, with some studies finding significant positive effects. These programs are similar to traditional mindfulness courses and have been shown to be beneficial for mental well-being, even when delivered through technology without a live facilitator. ^{1 2 3 4 5}

Is the Guided Digital Mindfulness Program safe for humans?

Research on mindfulness programs shows that while they can be beneficial, there are potential side effects, including mental and physical health issues. It's important for participants to be screened properly to minimize risks. ^{6 7 8 9 10}

How is the Guided Digital Mindfulness Program treatment different from other treatments for brain health?

The Guided Digital Mindfulness Programs are unique because they use digital platforms like smartphone apps and web-based tools to deliver mindfulness training, making it more accessible and personalized compared to traditional face-to-face methods. This digital approach can improve attention, reduce stress, and alleviate symptoms of depression and anxiety, offering a scalable and standardized way to enhance brain health. ^{11 12 13 14 15}

Research Team

Kevin Madore, PhD

Principal Investigator

Lumos Labs, Inc.

Eligibility Criteria

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 understand and speak English, follow written and verbal instructions, and give informed consent as assessed by study staff

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Electronic Mindfulness-Based Therapeutic Interventions for Weight, Weight-Related Behaviors, and Psychological Stress. [2022]

2. Netherlands 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A systematic literature review and meta-analysis on digital health interventions for people living with dementia and Mild Cognitive Impairment. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Mindfulness Interventions Delivered by Technology Without Facilitator Involvement: What Research Exists and What Are the Clinical Outcomes? [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Engagement Strategies to Improve Adherence and Retention in Web-Based Mindfulness Programs: Systematic Review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. [2022]

7. England pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Doing no harm in mindfulness-based programs: Conceptual issues and empirical findings. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Prevalence of harm in mindfulness-based stress reduction. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

The future of mindfulness training is digital, and the future is now. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

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

13. United States pubmed.ncbi.nlm.nih.gov

The Implementation of Mindfulness-Based Programs in the Swedish Healthcare System-A Qualitative Study. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

The Implementation of Mindfulness-Based Programs in the Swedish Healthcare System - A Survey Study of Service Providers. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Mindfulness Research Update: 2008. [2021]