Mindfulness Meditation for Psychological Distress

Overseen By David Creswell, PhD, Psychology

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Equa Health

Disqualifiers: Pregnancy, Psychosis, Schizophrenia

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

Compensation: Varies

Number of Visits: 14

Duration: 4 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on meditation and mindfulness, so it's unlikely that medication changes are required.

What data supports the effectiveness of the treatment Mindfulness Meditation for reducing psychological distress?

Research shows that mindfulness meditation can help reduce stress, anxiety, and burnout, and improve quality of life for people with chronic illnesses and healthcare professionals. It has also been found to decrease psychiatric hospitalizations in veterans with mental health issues. ^{1 2 3 4 5}

Is mindfulness meditation safe for participants in clinical trials?

Mindfulness meditation is generally considered safe, but some people may experience temporary feelings of anxiety or discomfort. More severe reactions, like psychosis, are rare and often linked to other factors such as the intensity of practice or personal mental health history. Programs like Mindfulness-Based Stress Reduction are designed to be adaptable to avoid causing distress. ^{2 6 7 8 9}

How is the treatment Mindfulness Meditation different from other treatments for psychological distress?

Mindfulness Meditation is unique because it focuses on training individuals to be present in the moment, which can help reduce distress by preventing unhelpful thoughts. Unlike some other treatments, it can be integrated into daily life through practices like meditation and mantram repetition, making it a flexible and accessible option for managing psychological distress. ^{1 10 11 12 13}

What is the purpose of this trial?

The goal of this research is to develop a new breathing feature on the meditation app, Equa, to help young adults who are distressed, understand their physiological responses and mindfulness skill development during meditation. Our main aims are to build an algorithm that can use physiologic signals to: * Give feedback about how participant physiology is changing during guided lessons on the meditation app, Equa * Measure how much participant mindfulness skills are improving Participants will: * Complete a survey about demographics, their thoughts and feelings before and after the mindfulness meditation program * Complete 14 smartphone guided mindfulness meditation training units while physiological measures are being recorded * Complete a few brief questionnaires before and after mindfulness practices to understand potential changes in their mindfulness skills

Research Team

David Creswell, PhD

Principal Investigator

Equa Health

Eligibility Criteria

This trial is for young adults experiencing stress and who want to improve their mindfulness skills using a meditation app. Participants must be willing to have their breathing patterns analyzed during guided meditations and complete surveys about their thoughts and feelings.

Inclusion Criteria

Indicate moderate to high levels of psychological distress over the past two weeks (composite score >9 on the Patient Health Questionnaire-9)

Fluent in English

Willing and able to wear earbud headphones and a shirt which uses sensors to track motion and physiological measures

Exclusion Criteria

Currently pregnant

Current or previous diagnosis with psychosis or schizophrenia

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants complete 14 smartphone guided mindfulness meditation training units while physiological measures are recorded

4 weeks

14 sessions (in-person)

Follow-up

Participants are monitored for changes in mindfulness skills and user satisfaction with the app

4 weeks

Treatment Details

Interventions

• Mindfulness Meditation

Trial Overview The study is testing a new feature on the Equa meditation app that provides feedback based on respiration signals during meditation. It aims to help users understand physiological changes and track improvements in mindfulness through guided lessons.

Participant Groups

Group I: Respiration Biosignal Feedback Condition Experimental Treatment 1 Intervention

Participants will complete guided seated Equa training lessons on a laboratory smartphone device while physiological measures are tracked. After training lessons, a respiration biosignal feedback chart will appear.

Who Is Running the Clinical Trial?

Equa Health

Lead Sponsor

Trials

1

Recruited

80+

Worcester Polytechnic Institute

Collaborator

Trials

19

Recruited

30,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

Mindfulness training, which includes group instruction in various meditation styles, helps individuals focus on their present experiences without being overwhelmed by negative thoughts.

There is growing evidence that incorporating mindfulness training into chronic disease management can reduce psychological distress and enhance the quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training: an adjunctive role in the management of chronic illness? Monshat, K., Castle, DJ.[2019]

Mindfulness meditation programs have been shown to significantly reduce stress, anxiety, depression, and burnout among nurses and nursing students, enhancing their overall well-being and empathy.

The review included 16 studies, but most were small-scale, which limits the generalizability of the findings; larger and more rigorous studies are needed to confirm these benefits in broader nursing populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness meditation for nurses and nursing students: An integrated literature review. van der Riet, P., Levett-Jones, T., Aquino-Russell, C.[2022]

This randomized controlled trial will assess the effectiveness of a telemedicine meditation intervention specifically designed for people with multiple sclerosis (MS) and their caregivers, involving 120 participants over a 2-month period.

The study aims to measure improvements in quality of life, anxiety, and depression, which could highlight the potential of mindfulness-based interventions as a valuable part of treatment for chronic diseases like MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telemedicine meditation intervention for people with multiple sclerosis and their caregivers: study protocol for a randomized controlled trial. Cavalera, C., Pagnini, F., Rovaris, M., et al.[2019]

An abbreviated Mindfulness-Based Stress Reduction (MBSR) program consisting of 6 weekly 75-minute sessions can effectively be implemented during staff lunch breaks, making it a practical training option for healthcare providers and clinic staff.

This adapted MBSR program is not only feasible but also well-accepted, suggesting it could enhance the well-being of healthcare workers in a workplace setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. Hazlett-Stevens, H.[2021]

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]

Mindfulness meditation, particularly through programs like Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), is widely used to treat various conditions such as stress, depression, and chronic pain, but concerns about its safety have emerged due to reported adverse events.

The viewpoint argues that many reported negative experiences during mindfulness meditation, such as anxiety or discomfort, are not true adverse events but rather expected reactions that can occur as individuals learn to manage their mental and physical states; severe outcomes like psychosis are often influenced by external factors rather than the meditation itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Are Adverse Events in Mindfulness Meditation? Binda, DD., Greco, CM., Morone, NE.[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]

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]

The Internet Mindfulness Meditation Intervention (IMMI) was found to be feasible and acceptable, with 31 out of 44 enrolled adults completing the study, indicating that online mindfulness training can engage participants effectively.

IMMI significantly increased daily meditation practice compared to the Access to Guided Meditation group, with participants practicing more days and for longer total minutes, suggesting that structured online training can enhance meditation habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial. Wahbeh, H., Oken, BS.[2022]

Mindfulness-based therapies, particularly Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), have been shown to effectively improve psychological health, manage pain, and reduce anxiety symptoms.

MBCT is specifically recommended as an additional treatment for unipolar depression, highlighting its role in supporting mental health alongside traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation practices as adjunctive treatments for psychiatric disorders. Marchand, WR.[2022]

Mindfulness-based programs (MBPs) significantly reduce psychological distress in adults, showing a small to moderate effect size in a meta-analysis of 15 trials involving 2,371 participants from 8 countries.

The effectiveness of MBPs was consistent across various demographics, including baseline distress levels, gender, age, education, and dispositional mindfulness, indicating broad applicability of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual participant data systematic review and meta-analysis of randomised controlled trials assessing adult mindfulness-based programmes for mental health promotion in non-clinical settings. Galante, J., Friedrich, C., Dalgleish, T., et al.[2023]

Mantram repetition, an ancient mindfulness practice, has been shown to effectively reduce psychological distress symptoms such as depression and anxiety, with a small overall effect size of 0.23 based on 12 studies.

This intervention is portable and cost-effective, outperforming standard therapies, suggesting it could be a valuable tool for practitioners to teach patients for managing daily stress and enhancing resilience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mantram repetition and psychological distress: A systematic review and meta-analysis. Schneider, JK., Abdullahi, SG., Easton, SD., et al.[2023]

Mindfulness Based Interventions (MBIs) have gained significant traction in recent years for their effectiveness in treating various psychiatric disorders, highlighting their growing importance in mental health care.

Research supports that MBIs work through cognitive, psychological, and neural mechanisms, making them a valuable addition to traditional treatment methods for improving mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions in Psychiatry. Shapero, BG., Greenberg, J., Pedrelli, P., et al.[2023]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Mindfulness training: an adjunctive role in the management of chronic illness? [2019]

2. Scotland pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness meditation for nurses and nursing students: An integrated literature review. [2022]

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

A telemedicine meditation intervention for people with multiple sclerosis and their caregivers: study protocol for a randomized controlled trial. [2019]

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

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. [2021]

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

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

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

What Are Adverse Events in Mindfulness Meditation? [2022]

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

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

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

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

9. Canada pubmed.ncbi.nlm.nih.gov

Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial. [2022]

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

Mindfulness meditation practices as adjunctive treatments for psychiatric disorders. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Individual participant data systematic review and meta-analysis of randomised controlled trials assessing adult mindfulness-based programmes for mental health promotion in non-clinical settings. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Mantram repetition and psychological distress: A systematic review and meta-analysis. [2023]

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

Mindfulness-Based Interventions in Psychiatry. [2023]