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

Otsuka Holdings Co., Ltd.1 site in 1 country100 target enrollmentMay 2, 2023

ConditionsHealth Knowledge, Attitudes, Practice

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Health Knowledge, Attitudes, Practice
Sponsor: Otsuka Holdings Co., Ltd.
Enrollment: 100
Locations: 1
Primary Endpoint: The total duration of time spent in meditation during the study
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to compare the frequency and duration of meditation in generally healthy adults between:

A novel approach to mindfulness meditation encompassing guided tea consumption
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.

Registry

clinicaltrials.gov

Start Date

May 2, 2023

End Date

July 24, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Otsuka Holdings Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 20 - 49 years (inclusive) at screening.
•Born in the USA.
•Self-report history of past participation in meditation but have not meditated in within 30 days (1 month) of screening.
•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.
•Able to download, install, and update apps using a smartphone.
•Has access to hot water to prepare the tea beverage.
•Regular (at least 3 days a week) consumer of caffeine.
•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.
•Has no plan to change nicotine habits during the study period.
•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.

Exclusion Criteria

•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.
•Visual or hearing impairments that cannot be corrected with glasses or contact lenses or hearing aids.
•Self-reported taste or smell impairments within the past 30 days of screening.
•Has a condition that prevents the subject from consuming caffeine (e.g., caffeine sensitivity, underlying heart condition).
•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).
•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.
•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).
•Elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.
•Use of blood thinners (e.g., Warfarin).
•Use of anti-hypertension medications.

Outcomes

Primary Outcomes

The total duration of time spent in meditation during the study

Time Frame: 8 weeks

Data will be obtained from the Daily Study Intervention Recall.

The frequency of meditation during the study

Time Frame: 8 weeks

Frequency will be expressed as days whereby a meditation day is defined as a day where subjects completed at least one meditation session. Data will be obtained from the Daily Study Intervention Recall.

Secondary Outcomes

The average duration of time in meditation calculated weekly(weekly over 8 weeks)
Changes from baseline (screening) in the total score of the Perceived Stress Scale(On Days 28 and 55)
Changes in the Mood Scale metrics(On Days 0 and 55)