Mindfulness Training for Psychological Distress

Overseen By Emily G Thomas, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

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: 17

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new breathing feature on the meditation app, Equa, designed to assist young adults experiencing psychological distress. The study will evaluate user feedback on the app and any improvements in mindfulness skills. Participants will engage in guided meditation sessions using the app, with some receiving feedback on their body's responses during meditation. Those who might benefit from joining have experienced psychological distress and are open to using meditation or stress management tools. As an unphased trial, this study offers participants the chance to explore innovative meditation techniques that could enhance mental well-being.

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 mindfulness training and does not mention medication changes.

What prior data suggests that this new breathing feature on the Equa app is safe for users?

Research has shown that mindfulness meditation is generally safe. Studies examining over 200 cases have found that mindfulness helps reduce stress. It is linked to lower stress levels and improved focus in various situations.

Mindfulness practices are typically considered low-risk. Although limited information exists on negative effects, available research suggests these practices are well-tolerated.

Specific safety data for mindfulness meditation with physiological feedback is limited. However, given the widespread and typically safe practice of mindfulness, adding feedback is unlikely to introduce significant risks. Participants can expect this treatment to be safe and effective in reducing stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how mindfulness meditation can be enhanced using physiological feedback. Unlike traditional mindfulness techniques, which often rely solely on self-reported progress, this method provides real-time physiological data to participants via an app. This feedback could help users better understand and improve their meditation skills. By providing a visual representation of physiological responses, this method aims to deepen the mindfulness experience and potentially boost its effectiveness in reducing psychological distress.

What evidence suggests that this mindfulness meditation app feature is effective for reducing psychological distress?

Research has shown that mindfulness meditation can reduce stress and mental discomfort. One study found that students who participated in mindfulness training experienced a clear drop in stress levels. Additionally, a review of over 200 studies confirmed that mindfulness-based therapy effectively reduces stress. Mindfulness practices can also boost focus and improve overall brain function. In this trial, participants in the experimental group will receive feedback on their physiological responses during mindfulness meditation, which might help manage mental distress. The control group will not receive this feedback, allowing for a comparison of outcomes between the two groups. ^{2 4 6 7 8}

Who Is on the Research Team?

David Creswell, Ph.D.

Principal Investigator

Equa Health

Are You a Good Fit for This Trial?

This trial is for young adults experiencing distress who are interested in using a meditation app to improve their mental health. Participants should be willing to complete surveys and mindfulness training units on their smartphone while physiological measures are recorded.

Inclusion Criteria

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

I am willing to give feedback on my training experience.

I am willing to be assigned to any treatment group in the study.

Exclusion Criteria

Currently pregnant

Current or previous diagnosis with psychosis or schizophrenia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Treatment

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

4 weeks

14 sessions (self-guided)

Follow-up

Participants are monitored for changes in mindfulness skills and physiological responses after treatment

2 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Meditation

Trial Overview The study tests the Equa meditation app's new breathing feature, which uses an algorithm to provide feedback based on physiological signals during guided meditations. It aims to assess user satisfaction and measure improvements in mindfulness skills.

How Is the Trial Designed?

Group I: Experimental Group, Physiological Feedback Experimental Treatment 1 Intervention

Following the guided meditation lessons, a subset of participants (the experimental group) will see a graph tracking their physiological responses from the guided meditation lesson and predictive mindfulness skill scores based on the algorithm development. The feedback chart is produced by the physiological measures tracked throughout the duration of the lesson, and is displayed within the Equa app, moments after the meditation lessons concludes.

Group II: Control Group, No Physiological Feedback Active Control 1 Intervention

Participants be randomly assigned to one of two different 14-unit smartphone meditation program groups that involve completing a 2-10 minute daily guided practice on their phones. Participants in both groups will follow the same 14 units of mindfulness meditation curriculum that consists of learning and practicing techniques to improve concentration, sensory clarity, and equanimity (Equa meditation app) and have access to additional curriculum. Physiological measures will be tracked throughout the duration of lessons. A subset of participants (the experimental group) will see a graph tracking their physiological responses from the guided meditation lesson and predictive mindfulness skill scores based on the algorithm development. The control group will not see the graph tracking their physiology.

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10160720/

Effectiveness of training programs based on mindfulness in ... The results indicate that students who participated in mindfulness training noticed a reduction in stress/psychological distress symptoms ...

2. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-023-02244-y

Effectiveness of training programs based on mindfulness in ... This study aimed to seek evidence regarding the effectiveness of mindfulness-based training programs in reducing psychological distress and promoting the well- ...

3. apa.org apa.org/topics/mindfulness/meditation

Mindfulness meditation: A research-proven way to reduce ... Researchers reviewed more than 200 studies of mindfulness among healthy people and found mindfulness-based therapy was especially effective for reducing stress ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0167268123003888

Mindfulness training, cognitive performance and stress ... We have always had the obvious hypothesis that mindfulness practice will improve performance on incentivized tasks and lead to better psychological outcomes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7511255/

The Effectiveness of Mindfulness-Based Stress Reduction ... The reviewed literature suggested that MBSR was effective in reducing HCPs experiences of anxiety, depression and stress.

6. nccih.nih.gov nccih.nih.gov/health/meditation-and-mindfulness-effectiveness-and-safety

Meditation and Mindfulness: Effectiveness and Safety | NCCIH Meditation and mindfulness practices usually are considered to have few risks. However, few studies have examined these practices for potentially harmful ...

7. nature.com nature.com/articles/s44220-023-00081-5

Systematic review and individual participant data meta- ... Mindfulness-based programs (MBPs) are widely used to prevent mental ill health. Evidence suggests beneficial average effects but wide variability.

8. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2021.724126/full

Mindfulness Is Associated With Lower Stress and Higher ... Mindfulness was associated with lower perceived stress and higher work engagement in both cross-sectional and longitudinal analyses.