Internet-based Meditation for Mental Health

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Psychiatric medications

Disqualifiers: Psychiatric disorders, Neurological disorders, others

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

Compensation: Varies

Number of Visits: 24

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants are not currently on psychiatric medications, so you would need to stop taking them to join the study.

What data supports the effectiveness of the treatment SOS Meditation for mental health?

Research on similar internet-based mindfulness and meditation programs shows they can improve mental health by reducing anxiety, stress, and negative emotions, and enhancing well-being and mental health, suggesting that SOS Meditation might have similar benefits. ^{1 2 3 4 5}

Is internet-based meditation generally safe for humans?

Research shows that while meditation can have positive effects, some people may experience negative effects like mental health issues. It's important to be aware of these potential risks and to have proper screening and safety measures in place. ^{6 7 8 9 10}

How is the Internet-based Meditation treatment different from other mental health treatments?

The Internet-based Meditation treatment is unique because it offers a self-guided, online approach to meditation, making it easily accessible and cost-effective for individuals with mental health challenges. Unlike traditional in-person therapy, this treatment can be accessed from anywhere, providing flexibility and convenience for users. ^{11 12 13 14 15}

What is the purpose of this trial?

The study will examine the effects of online meditation training on stress and anxiety in healthy participants. It will also examine the dose-response relationship between the amount of daily focused attention meditation practice and established mental health outcome measures.

Research Team

Manish Saggar, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults over 18 living in the USA who can follow instructions and are not regular meditators. It's not for those with severe vision or hearing issues, under psychiatric treatment, hospitalized for psychiatric disorders within a year, non-English speakers, or diagnosed with psychiatric/neurological disorders.

Inclusion Criteria

Able to follow basic instructions for prescreening and scheduling

Compliant with investigator instructions during the consent process and participation in the study

I do not regularly practice meditation.

Exclusion Criteria

Hospitalized for psychiatric disorders in the past year

People with a current diagnosis of psychiatric or neurological disorders

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Meditation Intervention

Participants in the meditation group practice SOS meditation for 10 minutes daily, with assessments of mental health and well-being

8 weeks

Daily practice, assessments at baseline and week 8

Waitlist Control

Participants in the control group receive no intervention but are assessed for baseline mental health and well-being

8 weeks

Assessments at baseline and week 8

Follow-up Meditation

Participants in the control group begin SOS meditation practice, while the initial meditation group continues self-reported meditation

8 weeks

Daily practice, assessments at week 8 and week 16

Follow-up

Participants are monitored for changes in mental health and well-being after the intervention

4 weeks

Treatment Details

Interventions

• SOS Meditation

Trial Overview The study tests if online SOS Meditation can reduce stress and anxiety in healthy people. It also looks at how different amounts of daily meditation practice affect mental health outcomes.

Participant Groups

Group I: Waitlist control Experimental Treatment 1 Intervention

Baseline to week 8: Subjects will be place in a control group which receives no intervention. However, several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess baseline mental health and well being scores. Week 8 to week 16: Subjects will be trained to meditate for 10 minutes daily, and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the efficacy of daily meditation practice on mental health and well being. Focused-attention meditation technique will be used to train participants. Specifically the SOS meditation technique will be employed.

Group II: Meditation group Experimental Treatment 1 Intervention

Baseline to week 8: Subjects will be trained to meditate for 10 minutes daily, and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the efficacy of daily meditation practice on mental health and well being. Focused-attention meditation technique will be used to train participants. Specifically the SOS meditation technique will be employed. Week 8 to week 16: Subjects will self report if they choose to continue SOS meditation and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the impact of continued meditation practice on mental health and well being.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Institute for Meditation and Inner Harmony

Collaborator

Trials

1

Recruited

300+

Feldman Foundation CA

Collaborator

Trials

1

Recruited

300+

Findings from Research

A study of 98 veterans with psychiatric disorders showed that while attendance in mindfulness-based cognitive therapy (MBCT) was low (average of 4.87 out of 8 sessions), those who attended had a significant reduction in psychiatric hospitalizations after the intervention.

Despite the challenges in implementing MBCT due to high dropout rates, the results suggest that MBCT could be beneficial for veterans at high risk for psychiatric hospitalization, warranting further prospective studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Engagement and Outcomes of Mindfulness-Based Cognitive Therapy for Veterans with Psychiatric Disorders. Marchand, WR., Yabko, B., Herrmann, T., et al.[2020]

A study involving 177 participants found that an internet-based mindfulness and metta-based trauma therapy (MMTT) was perceived as a credible and helpful intervention for improving self-regulation and reducing symptoms of PTSD, anxiety, and depression.

Participants rated guided and non-guided meditation practices as more beneficial than journaling, suggesting that MMTT could serve as a valuable adjunct to traditional treatments for trauma and stress-related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and Metta-based Trauma Therapy (MMTT): Initial Development and Proof-of-Concept of an Internet Resource. Frewen, P., Rogers, N., Flodrowski, L., et al.[2021]

A 9-week online mindfulness-based meditation program (Integral Meditation) significantly improved mental wellbeing and reduced anxiety in healthy adults with higher baseline trait anxiety, as shown by self-reported questionnaires.

The study involved 84 participants divided into treated and control groups, and while the program was effective for those with higher anxiety, it did not significantly impact perceived stress levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Short-Term Mindfulness-Based Intervention During COVID-19 Quarantine in Italy: Effects on Wellbeing, Stress, and Anxiety. Fazia, T., Bubbico, F., Nova, A., 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]

A systematic review of 83 studies involving 6703 participants found that 8.3% experienced adverse events (AEs) related to meditation, with higher prevalence in observational studies (33.2%) compared to experimental studies (3.7%).

The most common adverse events included anxiety (33%), depression (27%), and cognitive anomalies (25%), indicating that meditation can lead to negative effects, even in individuals without prior mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in meditation practices and meditation-based therapies: a systematic review. Farias, M., Maraldi, E., Wallenkampf, KC., 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]

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]

A self-guided, Internet-based mantram repetition program (MRP) was found to be feasible for undergraduate students, with 88.3% completing all modules and 76.7% responding to follow-up questions.

Participants reported practicing the mantram repetition an average of 4.46 days per week and 3.26 times per day, indicating a strong engagement with the program, which suggests potential for managing mental health challenges in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of a brief, Internet-based mantram repetition program for undergraduate students. Vannini, MBN., McLean, CL., Bormann, JE., et al.[2022]

Web-based mindfulness interventions were effective in reducing depression and anxiety in clinical populations, with significant improvements noted in overall anxiety (g=-0.433) and in the anxiety disorder subgroup (g=-0.719) based on a systematic review of 12 studies involving 756 participants.

These interventions also enhanced quality of life and mindfulness skills, particularly benefiting those with clinical anxiety, although they showed limited effectiveness for depression specifically in the depression disorder subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Mindfulness Interventions for Mental Health Treatment: Systematic Review and Meta-Analysis. Sevilla-Llewellyn-Jones, J., Santesteban-Echarri, O., Pryor, I., et al.[2020]

References

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

Treatment Engagement and Outcomes of Mindfulness-Based Cognitive Therapy for Veterans with Psychiatric Disorders. [2020]

2. England pubmed.ncbi.nlm.nih.gov

User value and usability of a web-based mindfulness intervention for families living with mental health problems. [2018]

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

Mindfulness and Metta-based Trauma Therapy (MMTT): Initial Development and Proof-of-Concept of an Internet Resource. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Online Short-Term Mindfulness-Based Intervention During COVID-19 Quarantine in Italy: Effects on Wellbeing, Stress, and Anxiety. [2022]

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

Effects of an Online Meditation Course on Quality of Life and Positive Emotions: A Prospective Observational Study (EXPANSION Study). [2023]

6. England pubmed.ncbi.nlm.nih.gov

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

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

Adverse effects of meditation: a preliminary investigation of long-term meditators. [2022]

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

Adverse events in meditation practices and meditation-based therapies: a systematic review. [2021]

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

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

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

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

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

The feasibility of a brief, Internet-based mantram repetition program for undergraduate students. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Web-Based Mindfulness Interventions for Mental Health Treatment: Systematic Review and Meta-Analysis. [2020]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Effect of the Online Mindfulness-Based Stress Reduction on Anxiety and Depression Status of COVID-19 Patients Treated in Fangcang Hospitals: A Randomized Controlled Trial. [2023]

14. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of an 8-Week Web-Based Mindfulness Virtual Community Intervention for University Students on Symptoms of Stress, Anxiety, and Depression: Randomized Controlled Trial. [2020]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness training online for stress reduction, a global measure. [2015]