Health Knowledge, Attitudes, PracticeNCT05832645
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 study testing Meditation with guided tea consumption and Breathing meditation in people with Health Knowledge, Attitudes, Practice, run by Otsuka Holdings Co., Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- Meditation with guided tea consumption and Breathing meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2023to 24 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
- Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Who cannot join
- 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.
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- 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.
- Use of prescription stimulant medications [e.g., amphetamines/dextroamphetamine (Adderall), methylphenidate (Ritalin, Concerta), methamphetamine (Desoxyn), dextroamphetamine (Dexedrine), lisdexamfetamine (Vyvanse)]. Use of over-the-counter as-needed medications [e.g., for temporary pain relief (e.g., aspirin, ibuprofen, and acetaminophen), common cold/flu symptoms (pain relievers like aspirin, ibuprofen and acetaminophen; nasal decongestant sprays like oxymetazoline and phenylephrine; and oral decongestants, like pseudoephedrine), and seasonal allergies (e.g., Zyrtec, Claritin, Allegra)] is allowed.
- Use of cannabis, marijuana or cannabinoid products, including those that are consumed, orally inhaled, smoked, applied topically, etc. within 6 months of screening.
- Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. Subjects who are pregnant during the study will be discontinued.
- Recent history of (within 12 months of screening) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Has a condition the Clinical Investigator believes would interfere with her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Innovation Services
Addison, Illinois, 60101
About this study
Official title: 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
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.
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- Meditation with guided tea consumption, Breathing meditation
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation with guided tea consumptionOther
Mindful consumption of tea along with an approximately 10-min guide
Breathing meditationOther
10-min breathing meditation
| Study group | Role | What they receive |
|---|---|---|
| A novel mindfulness approach | Experimental | Not described Receives: Other: Meditation with guided tea consumption |
| Breathing meditation | Other | Not described Receives: Other: Breathing meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of meditation during the study
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.
Measured: 8 weeks
The total duration of time spent in meditation during the study
Data will be obtained from the Daily Study Intervention Recall.
Measured: 8 weeks
Secondary outcomes (3)
The average duration of time in meditation calculated weekly
Measured: weekly over 8 weeks
Changes from baseline (screening) in the total score of the Perceived Stress Scale
Five-point scale from 0 (never) to 4 (very often). The total score ranges from 0 to 40 where higher values mean higher stress levels
Measured: On Days 28 and 55
Changes in the Mood Scale metrics
- relaxed level
- calm level
- irritated level
- focused level
- anxious level
- energetic level
- lively level
- lethargic level
- listless level
- nervous level
- pleasure level (calculated)
- arousal level (calculated)
- vitality level (calculated)
- stability level (calculated)
The first ten items will be answered on a 6-point scale from 0 (not at all) to 5 (extremely). The last four metrics will be calculated according to the Two-Dimensional Mood Scale
Measured: On Days 0 and 55
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start2 May 2023
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Holdings Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Innovation Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832645
- Sponsor's protocol ID
- BIO-2304
- Status last verified
- Feb 2024
- First submitted
- 13 Apr 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanaka-Kanegae R, Yamada K, Cook CM, Blonquist TM, Taggart KD, Hamada K. Feasibility and Efficacy of a Novel Mindfulness App Used With Matcha Green Tea in Generally Healthy Adults: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Dec 10;12:e63078. doi: 10.2196/63078.
PubMed 39657179
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05832645
- Acronym / sponsor ID
- BIO-2304
- Conditions
- Health Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Otsuka Holdings Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Innovation Services
- Study start
- 2 May 2023 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A novel mindfulness approach | Experimental | Other: Meditation with guided tea consumption |
| Breathing meditation | Other | Other: Breathing meditation |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditation with guided tea consumptionMindful consumption of tea along with an approximately 10-min guide | Other | A novel mindfulness approach |
| Breathing meditation10-min breathing meditation | Other | Breathing meditation |
Primary outcome
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.
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.
3 secondary outcomes
The average duration of time in meditation calculated weekly
Time frame: weekly over 8 weeks
Changes from baseline (screening) in the total score of the Perceived Stress Scale
Time frame: On Days 28 and 55
Changes in the Mood Scale metrics
Time frame: On Days 0 and 55
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 39657179Tanaka-Kanegae R, Yamada K, Cook CM, Blonquist TM, Taggart KD, Hamada K. Feasibility and Efficacy of a Novel Mindfulness App Used With Matcha Green Tea in Generally Healthy Adults: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Dec 10;12:e63078. doi: 10.2196/63078.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation with guided tea consumption and Breathing meditation in people with Health Knowledge, Attitudes, Practice, run by Otsuka Holdings Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of meditation during the study (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05832645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.