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A Study Investigating the Effects of a Novel Mindfulness Approach on Frequency and Duration of Meditation and Self-Reported Stress and Mood in Generally Healthy Adults | Clinical Trials | Clareo Health

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A Study Investigating the Effects of a Novel Mindfulness Approach on Frequency and Duration of Meditation and Self-Reported Stress and Mood in Generally Healthy Adults

A Randomized, Parallel Study Investigating the Effects of a Novel Approach to Mindfulness on Frequency and Duration of Meditation and Self-Reported Stress and Mood in Generally Healthy Adults

NCT05832645•Otsuka Holdings Co., Ltd.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to compare the frequency and duration of meditation in generally healthy adults between: 1. A novel approach to mindfulness meditation encompassing guided tea consumption 2. Breathing meditation Participants will be encouraged to meditate every day in either way listed above and asked to complete Daily Study Intervention Recall for 8 weeks. Additionally, self-reported aspects of stress and mood will be evaluated.

Eligibility

Age

20 - 49 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Age 20 - 49 years (inclusive) at screening.
•2. Born in the USA.
•3. Self-report history of past participation in meditation but have not meditated in within 30 days (1 month) of screening.
•4. Has an Apple ID, an email address linked to an Apple ID, and access to a dedicated smartphone capable of downloading and running the study specific app.
•5. Able to download, install, and update apps using a smartphone.
•6. Has access to hot water to prepare the tea beverage.
•7. Regular (at least 3 days a week) consumer of caffeine.
•8. Willing to maintain habitual diet (including supplements) and lifestyle (including avoidance of stressful events such as change in employment), physical activity patterns, and body weight during the study period.
•9. Has no plan to change nicotine habits during the study period.
•10. Has no health conditions that would prevent her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of the pre-screening questionnaire.
+1 more criteria

Exclusion Criteria

•1. Answered "Extremely" for all the positive feelings (energetic, lively, relaxed, and calm), or answered "Not at all" for all the negative feelings (lethargic, listless, irritated, and nervous), or gave same answer (e.g., Not at all) for all the feelings on the Mood State questionnaire completed during screening.
•2. Visual or hearing impairments that cannot be corrected with glasses or contact lenses or hearing aids.
•3. Self-reported taste or smell impairments within the past 30 days of screening.
•4. Has a condition that prevents the subject from consuming caffeine (e.g., caffeine sensitivity, underlying heart condition).
•5. Clinically diagnosed neurologic or psychiatric disorders (e.g., bipolar disorder, clinical depression, post-partum depression) currently requiring medication (such as antipsychotics, anticonvulsants, and antiparkinsonian agents as well as medications for bipolar disorder).
•6. Clinically diagnosed sleep disorders (e.g., sleep apnea, insomnia, narcolepsy) requiring prescribed medical intervention (e.g., cognitive behavioral therapy, continuous positive airway pressure (CPAP), prescription medication such as zolpidem, zaleplon, eszopiclone, ramelteon, and suvorexant). Use of over-the-counter sleeping aid supplements such as melatonin, methylcobalamin (vitamin B12), 5-hydroxytryptophan (5-HTP), L-theanine, magnesium, and valerian is allowed.
•7. Contraindication or allergy/sensitivity to any components in the study product or allergens present in the facility used to manufacture or pack the study product (see Appendix 10).
•8. Elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.
•9. Use of blood thinners (e.g., Warfarin).
•10. Use of anti-hypertension medications.
+5 more criteria

Locations (1)

Biofortis Innovation Services

Addison, Illinois, United States

Key Dates

Start Date

May 2, 2023

Primary Completion Date

July 24, 2023

Completion Date

July 24, 2023

Last Updated

February 28, 2024

Enrollment

100

ACTUAL participants

Conditions

Health Knowledge, Attitudes, Practice

Interventions

Meditation with guided tea consumption

OTHER

Breathing meditation

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Investigating the Effects of a Novel Mindfulness Approach on Frequency and Duration of Meditation and Self-Reported Stress and Mood in Generally Healthy Adults

Inclusion Criteria

Exclusion Criteria

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