- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06934330
Effect of Tao Calligraphy Meditation and Energized Water on Depression
Effect of Tao Calligraphy Meditation and Energized Water on Depression Randomized Control Cross-over Study
The goal of this controlled randomized clinical study is to learn if a Tao Calligraphy Mindfulness and Energized water Practice works to improve Unipolar Depression. The main questions it aims to answer are:
- Does Tao Calligraphy Mindfulness practice and drinking Energized water improve the subjective symptoms of Unipolar Depression in adults?
- Does Tao Calligraphy Mindfulness practice and drinking Energized water improve the clinical symptoms and signs of Unipolar Depression in adults?
- Will any improvement in the John Ware's SF-36 Quality of Life questionnaire, in the Patient Health Questionnaire (PHQ) -9 and in the Beckman Anxiety Inventory (BAI) -21 in adults be statistically significant? Investigators will compare the values of these three scales at the beginning of the mindfulness and energized water practices to their values at six weeks of practice and control groups.
Participants will:
- be randomized into practice and control groups
- complete the set of three questionnaires upon entry into the study - (the baseline or zero time point; at the 6-weeks time point, and at the 12-weeks time point
- practice the mindfulness techniques with Tao Calligraphy for a minimum of thirty minutes daily and energized water practice for a minimum of five minutes daily.
Study Overview
Status
Conditions
Detailed Description
Objective
The goal of this study is to measure the positive effects of a unique form of mindfulness practice that involves engaging with Tao art (tracing the Tao Calligraphy "Greatest Love" while listening to or singing the Tao Music or Tao Song "Greatest love") combined with energized water drinking on human adult well-being and depression symptoms and signs. Investigators will study the impact of this Tao art mindfulness practice on three standard research instruments: the John Ware's SF-36 Quality of Life questionnaire, the PHQ-9 questionnaire and the BAI-21 Beckman Anxiety Inventory
Hypotheses
The research hypotheses are that individuals with unipolar depression who receive energy transmission (blessing) for their affliction, who will regularly practice meditations with Tao Calligraphy and drink energized water will report:
- a decrease in the symptoms of their illness as perceived subjectively.
- an improvement of the clinical status of their illness, as observed by their clinicians.
- improvement of well-being or clinical status as measured by standardized scientific questionnaire (s).
For statistical analysis of scores obtained from questionnaires, the Anova and regression analysis will be used to evaluate the null hypothesis. The p value will represent how unlikely the observed data would be if the null hypothesis were actually true and investigators will use them to reach conclusions. The confidence level is set at 95% and if we receive p < 0.05, then results are considered statistically significant. The correlation coefficient will be used to determine any correlation between various factors (e.g. effects of age, sex, length, and frequency of mindfulness practices and other) on outcome and regression analysis will be used to determine the relation of independent and dependent variables.
Background and Theoretical Framework
Depression is a mental disorder characterized by a depressed mood, lack of interest, decreased concentration, decreased self-esteem, increased fatigue, reduced activity, feelings of worthlessness, drive reduction for longer periods of time and suicidal thoughts. Depression affects a person's thoughts, behaviour, feelings and sense of well-being. Depression is one of the most common mental disorders, affecting more than 300 million people of all ages globally, and is now the leading cause of disability. Depression is a major contributor to mortality, morbidity, disability, and economic costs in the United States. Centre for Disease Control and Prevention (CDC) analyzed 2020 Behavioral Risk Factor Surveillance System (BRFSS) data to estimate the national, state-level, and county-level prevalence of U.S. adults aged ≥18 years self-reporting a lifetime diagnosis of depression (referred to as depression). During 2020, the age-standardized prevalence of depression among adults was 18.5%.
Mindfulness meditation-based therapies are being increasingly used as interventions for psychiatric disorders. Mindfulness refers to a state of awareness that arises from paying attention to the present moment, without judgment, whereas meditation refers to a practice or technique that can cultivate mindfulness, inner peace, and more. Mindfulness practices are often synonymous with meditation, and the terms are often used interchangeably.
Mindfulness practices have become increasingly popular as complementary therapeutic strategies for a variety of medical and psychiatric conditions. Likewise, mindfulness and meditation practices have been shown to increase self-compassion and improve memory and emotional regulation. In a comprehensive meta-analysis of 209 studies, the authors concluded that mindfulness-based therapy was effective for many types of psychological problems, while being especially good for reducing anxiety, depression, and stress. In another overall review of mindfulness-based interventions, they were found to be effective for many common and diverse mental, physical, and social conditions.
In recent decades, mindfulness and meditation practices and programs have become increasingly commonplace for stress management and reduction because they are effective. It is no wonder that mindfulness-based meditation practices lead to greater mental, physical, and psychological well-being, with one of the key mechanisms for such outcomes being their effect on the regulation or reduction of stress.
Besides mindfulness and meditation practices, the interest in the application of the arts for public health and well-being has also grown in recent years. Self-expression through art or engaging with different forms of art has been found to be helpful for many health conditions, and doctors in the United Kingdom have started prescribing "the arts" to treat or positively influence many kinds of health conditions.
Some forms of art are also meditative and contemplative, and many can be readily transformed into such a process. The mindfulness-based meditation being explored in this research rests in part on the benefits of music, singing or chanting, and calligraphy tracing (in particular, tracing a unique form of Chinese calligraphy).
Chinese calligraphic writing is a dynamic process that uses an ink-laden brush to create defined configurations of characters. Revered as one of the most important art forms in China, as a mindfulness practice, it has also been shown to help reduce stress and improve mental well-being. The practice of Chinese calligraphy writing facilitates the development of concentration, creativity, and relaxation, which can lead to a more peaceful mental state. Studies in the medical field have confirmed its significant effects on psychosomatic conditions, post-traumatic hyper-arousal symptoms, hypertension, and type 2 diabetes. Other research publications have shown how it can improve cognitive function in the elderly, improve neuropsychiatric symptoms, and reduce stress. In one case, a man who was in a coma for two years awakened and continued to improve after his medical team took his hand and helped him to trace calligraphy daily with his finger.
This research will explore the effects of a unique mindfulness-based meditation that combines tracing the Tao Calligraphy "Greatest Love" while listening to, singing, or chanting the Tao Song "Greatest Love" and drinking energized water. Investigators will study its effect upon general well-being and upon specific depressive symptoms.
Tao Calligraphy is based on a unique branch of Chinese calligraphy known as Yi Bi Zi, which applies one-stroke writing. Every character is written with one continuous stroke of the brush, with the brush always in contact with the paper.
In a unique style of moving meditation, participants will focus on a work of Tao Calligraphy art, tracing the characters with their fingers while simultaneously listening to or singing/chanting (silently or aloud) the Tao Music or Song, which enables them to achieve deep concentration and relaxation during wakefulness.
The Tao Song "Greatest Love" consists of short, inspiring verses that are repeated, and is a beautiful way to lift and inspire peoples' hearts and help them to experience peace and calm. The song was professionally recorded and is available for study participants as a free distribution.
The investigators have already discussed the value of Tao art mindfulness meditations for improving depression, anxiety, pain, and health, and how this appears to contribute to numerous beneficial outcomes related to well-being by the Short Form 36-item (SF-36) questionnaire to measure quality of life and by the European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC Quality of Life Questionnaire (QLQ) C-30).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Peter Hudoba De Badyn, MD, FRCS,
- Phone Number: 604-904-7712
- Email: sharesearchfoundation@yahoo.ca
Study Contact Backup
- Name: Cynthia Hamilton, PhD
- Phone Number: 778 847-3617
- Email: cynthialhamiltonconsulting@gmail.com
Study Locations
-
-
Hawaii
-
Kahului, Hawaii, United States, 96732
- Recruiting
- Satori Family Wellness Center
-
Contact:
- Laurie Omuro-Yamamoto, PhD
- Phone Number: 808-205-6637
- Email: laurieoy@gmail.com
-
Contact:
- Anette Omuro
- Phone Number: (808) 281-2225
- Email: annetteyeiko@gmail.com
-
Principal Investigator:
- Laurie Omuro-Yamamoto, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 19 and over with a primary diagnosis as one Unipolar depression according to International Classification of Diseases (ICD)-10 criteria is present and diagnosed by a licensed physician.
- Willingness and ability to comply with data collection requirements
- Submission of required documentation before entering the study, including informed consent and consent to release of information
- Willingness to allow their data to be used for research purposes and published as deemed fit (while conforming to all applicable privacy laws) by Sha Research Foundation
- Willingness to practice the daily mindfulness practices for at least 30 minutes and follow the study protocol
Exclusion Criteria:
- Not meeting any of the inclusion criteria
- Bipolar disorders, schizophrenia (psychosis)
- Treatment with highly potent neuroleptics
- Unwillingness to participate in data gathering
- Unable to follow the practice regimen, including the daily individual mindfulness practices for at least 30 minutes
- Pregnant or nursing. Participants who become pregnant during the study will be required to end their participation.
- Serious mental disorders (e.g., schizophrenia)
- There is no exclusion criteria placed upon potential subjects related to national origin, culture, ethnicity, race, sex, physical disability, sexual orientation, religion, or spiritual practices.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Practice Group
The Practice group will start practices at baseline zero time point and will stop practices after six weeks at 6-weeks time point.
Participants in the Practice group will practice Mindfulness practice with Calligraphy at least 30 minutes daily and drink about 1 litre of Energized water daily for six weeks.
All participants in the Practice group will complete the set of all three questionnaires upon entry into the study - at the baseline zero time point; at the 6-weeks time point and at the 12-weeks time point.
|
During mindfulness practice with Tao Art (Calligraphy and Song Greatest Love), participants will repeatedly trace the lines of calligraphy with fingers while listening to, singing, or chanting with Tao Song.
This enables them to achieve deep concentration, while maintaining fully alert state.
The practice can be done in sitting or standing, depending on the health status and age and will last 30 minutes and is done daily for six weeks.
Participants will drink energized water from a bottle that received subtle energy transmission.
They will replenish water daily and activate the transmission in the bottle to energize the water.
Participants will drink about 1 litre of energized water a day for six weeks.
|
|
No Intervention: Control Group
The Control group will crossover to become Practice group at the 6-weeks time point. Participants will start practices at the 6-weeks time point and will stop practices after six weeks at 12-weeks time point. All participants in Control Group will complete the set of all three questionnaires upon entry into the study at Baseline time point; at 6-weeks time point and at 12-weeks time point. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Change from Baseline in Quality of Life Scores on 36-item short-form Quality of Life Questionnaire (SF-36) at 6 weeks
Time Frame: From start of Mindfulness practices with Tao Art (Calligraphy and Song Greatest Love) and drinking energized water to end of practices at 6 weeks.
|
Description: A 36-item short-form Quality of Life Questionnaire (SF-36) was constructed to survey health status. The investigators chosen the longer 36-item version to assess the impact of the Tao art mindfulness practice and drinking energized water on Quality of Life of participants with unipolar depression. The SF-36 includes one multi-item scale for eight health concepts:
Through a complex calculation, eight scores are derived from answers to 36 questions of SF-36. Finally, these eight scores are linearly transformed to a 0-to-100 scale, with 100 being the best possible outcome. |
From start of Mindfulness practices with Tao Art (Calligraphy and Song Greatest Love) and drinking energized water to end of practices at 6 weeks.
|
|
Mean Change from Baseline in Scores on PHQ-9 questionnaire at 6 weeks
Time Frame: From start of Mindfulness practices with Tao Art (Calligraphy and Song Greatest Love) and drinking energized water to end of practices at 6 weeks.
|
The PHQ-9 questionnaire that measures criteria of Mental Disorders, will be used to assess the impact of the Tao art mindfulness practice and drinking energized water on unipolar depression. PHQ-9 has 9 scores, derived from answers to 9 questions of PHQ-9. These 9 scores have a 0-to-3 scale, with 3 being the worst possible outcome. Participants select the scale to each score depending on how frequently experience depressive symptoms during two weeks as: Not at all = 0; Several days = 1; More then half of the days = 2; Nearly every day = 3. Then, add up the scores for each item to get a total. Total scores on the PHQ-9 can range from 1 to 27, with higher scores indicating more severe Depression:
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From start of Mindfulness practices with Tao Art (Calligraphy and Song Greatest Love) and drinking energized water to end of practices at 6 weeks.
|
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Mean Change from Baseline in Scores on BAI-21 (Beck Anxiety Inventory) Scale at 6 weeks
Time Frame: From start of Mindfulness practices with Tao Art (Calligraphy and Song Greatest Love) and drinking energized water to end of practices at 6 weeks.
|
The BAI-21, Beck Anxiety Inventory Scale, will be used to assess the impact of the Tao art mindfulness practice and drinking energized water on unipolar depression. Each of the 21 items of BAI-21 is descriptive of subjective, somatic, or pain-related symptoms of anxiety. The participant rates how much he or she has been bothered by that symptom in the past week. Each question has the same set of four possible answer choices with a scale of 0-3, with 3 being the worst possible outcome. Then, add up the scores for each item to get a total. Total scores on the BAI-21 can range from 1 to 63, with higher scores indicating more severe Depression:
|
From start of Mindfulness practices with Tao Art (Calligraphy and Song Greatest Love) and drinking energized water to end of practices at 6 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Hudoba De Badyn, MD, FRCS,, Sha Research Foundation
- Principal Investigator: Laurie Omuro-Yamamoto, PhD, Satori Family Wellness Center
Publications and helpful links
General Publications
- Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Trivedi MH. Major Depressive Disorder in Primary Care: Strategies for Identification. J Clin Psychiatry. 2020 Mar 17;81(2):UT17042BR1C. doi: 10.4088/JCP.UT17042BR1C.
- Kao H Sr, Zhu L, Chao AA, Chen HY, Liu IC, Zhang M. Calligraphy and meditation for stress reduction: an experimental comparison. Psychol Res Behav Manag. 2014 Feb 13;7:47-52. doi: 10.2147/PRBM.S55743. eCollection 2014.
- Kobau R, Seligman ME, Peterson C, Diener E, Zack MM, Chapman D, Thompson W. Mental health promotion in public health: perspectives and strategies from positive psychology. Am J Public Health. 2011 Aug;101(8):e1-9. doi: 10.2105/AJPH.2010.300083. Epub 2011 Jun 16.
- White JD. National Cancer Institute's support of research to further integrative oncology practice. J Natl Cancer Inst Monogr. 2014 Nov;2014(50):286-7. doi: 10.1093/jncimonographs/lgu036. No abstract available.
- Marikar Bawa FL, Mercer SW, Sutton JW, Bond CM. Mindfulness for people with chronic pain: Factors affecting engagement and suggestions for programme optimisation. Health Expect. 2023 Jun;26(3):1287-1307. doi: 10.1111/hex.13745. Epub 2023 Mar 12.
- Jamil A, Gutlapalli SD, Ali M, Oble MJP, Sonia SN, George S, Shahi SR, Ali Z, Abaza A, Mohammed L. Meditation and Its Mental and Physical Health Benefits in 2023. Cureus. 2023 Jun 19;15(6):e40650. doi: 10.7759/cureus.40650. eCollection 2023 Jun.
- Pascoe MC, de Manincor M, Tseberja J, Hallgren M, Baldwin PA, Parker AG. Psychobiological mechanisms underlying the mood benefits of meditation: A narrative review. Compr Psychoneuroendocrinol. 2021 Mar 10;6:100037. doi: 10.1016/j.cpnec.2021.100037. eCollection 2021 May.
- Poissant H, Mendrek A, Talbot N, Khoury B, Nolan J. Behavioral and Cognitive Impacts of Mindfulness-Based Interventions on Adults with Attention-Deficit Hyperactivity Disorder: A Systematic Review. Behav Neurol. 2019 Apr 4;2019:5682050. doi: 10.1155/2019/5682050. eCollection 2019.
- de Witte M, Orkibi H, Zarate R, Karkou V, Sajnani N, Malhotra B, Ho RTH, Kaimal G, Baker FA, Koch SC. From Therapeutic Factors to Mechanisms of Change in the Creative Arts Therapies: A Scoping Review. Front Psychol. 2021 Jul 15;12:678397. doi: 10.3389/fpsyg.2021.678397. eCollection 2021.
- de Witte M, Lindelauf E, Moonen X, Stams GJ, van Hooren S. Music Therapy Interventions for Stress Reduction in Adults With Mild Intellectual Disabilities: Perspectives From Clinical Practice. Front Psychol. 2020 Dec 10;11:572549. doi: 10.3389/fpsyg.2020.572549. eCollection 2020.
- Kao HS, Lam SP, Kao TT. Chinese calligraphy handwriting (CCH): a case of rehabilitative awakening of a coma patient after stroke. Neuropsychiatr Dis Treat. 2018 Jan 31;14:407-417. doi: 10.2147/NDT.S147753. eCollection 2018.
- Zhang D, Lee EKP, Mak ECW, Ho CY, Wong SYS. Mindfulness-based interventions: an overall review. Br Med Bull. 2021 Jun 10;138(1):41-57. doi: 10.1093/bmb/ldab005.
- Simpson FM, Perry G, Thompson WF. Assessing Vocal Chanting as an Online Psychosocial Intervention. Front Psychol. 2021 Jun 1;12:647632. doi: 10.3389/fpsyg.2021.647632. eCollection 2021.
- Perry G, Polito V, Sankaran N, Thompson WF. How Chanting Relates to Cognitive Function, Altered States and Quality of Life. Brain Sci. 2022 Oct 27;12(11):1456. doi: 10.3390/brainsci12111456.
- Spitzer RL, Williams JB, Kroenke K, Linzer M, deGruy FV 3rd, Hahn SR, Brody D, Johnson JG. Utility of a new procedure for diagnosing mental disorders in primary care. The PRIME-MD 1000 study. JAMA. 1994 Dec 14;272(22):1749-56.
- Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
- Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
- Al Ozairi A, Alsaeed D, Al-Ozairi E, Irshad M, Crane RS, Almoula A. Effectiveness of virtual mindfulness-based interventions on perceived anxiety and depression of physicians during the COVID-19 pandemic: A pre-post experimental study. Front Psychiatry. 2023 Jan 9;13:1089147. doi: 10.3389/fpsyt.2022.1089147. eCollection 2022.
- Cassano P, Fava M. Depression and public health: an overview. J Psychosom Res. 2002 Oct;53(4):849-57. doi: 10.1016/s0022-3999(02)00304-5.
- de Zwart PL, Jeronimus BF, de Jonge P. Empirical evidence for definitions of episode, remission, recovery, relapse and recurrence in depression: a systematic review. Epidemiol Psychiatr Sci. 2019 Oct;28(5):544-562. doi: 10.1017/S2045796018000227. Epub 2018 May 17.
- Lee B, Wang Y, Carlson SA, Greenlund KJ, Lu H, Liu Y, Croft JB, Eke PI, Town M, Thomas CW. National, State-Level, and County-Level Prevalence Estimates of Adults Aged >/=18 Years Self-Reporting a Lifetime Diagnosis of Depression - United States, 2020. MMWR Morb Mortal Wkly Rep. 2023 Jun 16;72(24):644-650. doi: 10.15585/mmwr.mm7224a1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00050084
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
The protocol with the statistical analysis plan of the study will be available from April 30, 2025 until the end of the study on January 10, 2027.
The mean change from baseline in the SF-36 Quality of Life Scores, the PHQ-9 Scores and the BAI-21 Beckman Anxiety Inventory Scores after six weeks of mindfulness practices with Tao Art and energized water will be available from January 10, 2027 until December 31, 2027.
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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