Unipolar DepressionNCT06934330
Effect of Tao Calligraphy Meditation and Energized Water on Depression
A study testing Mindfulness practice with Tao Art (Calligraphy and Song Greatest Love) and Drinking Energized water in people with Unipolar Depression, run by Sha Research Foundation at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- Mindfulness practice with Tao Art (Calligraphy and Song Greatest Love) and Drinking Energized water
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2022to 10 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Satori Family Wellness Center
Kahului, Hawaii, 96732
About this study
Official title: 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.
Read more
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.
Read the 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).
- Conditions
- Unipolar Depression
- Being tested
- Mindfulness practice with Tao Art (Calligraphy and Song Greatest Love), Drinking Energized water
- Keywords
- Unipolar Depression, Well-being, SF 36 Quality of life questionnaire, PHQ-9 questionnaire, Tao Calligraphy, Healing Art, Chinese Calligraphy, BAI-21 Beckman Anxiety Inventory
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness practice with Tao Art (Calligraphy and Song Greatest Love)Behavioural
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.
Drinking Energized waterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Practice Group | Experimental | 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. Receives: Behavioral: Mindfulness practice with Tao Art (Calligraphy and Song Greatest Love); Other: Drinking Energized water |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in Quality of Life Scores on 36-item short-form Quality of Life Questionnaire (SF-36) 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:
- limitations in physical activities;
- limitations in social activities;
- limitations in usual role activities;
- bodily pain;
- general mental health (psychological distress and well-being);
- limitations in usual role activities because of emotional problems;
- vitality (energy and fatigue);
- general health perceptions.
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.
Measured: 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
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:
- Scores ranging from 1-4 = minimal depression.
- Scores ranging from 5-9 = mild depression.
- Scores ranging from 10-14 = moderate depression.
- Scores ranging from 15-19 = moderately severe depression.
- Scores ranging from 20-27 = severe depression.
Measured: 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 BAI-21 (Beck Anxiety Inventory) Scale 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:
- Scores ranging from 1-10 = normal ups and downs.
- Scores ranging from 11-16 = mild mood disturbance.
- Scores ranging from 17-20 = borderline depression.
- Scores ranging from 21-30 = moderate depression.
- Scores ranging from 31-40 = severe depression.
- Scores ranging from 40-63 = extreme depression.
Measured: From start of Mindfulness practices with Tao Art (Calligraphy and Song Greatest Love) and drinking energized water to end of practices at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start10 Feb 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Unipolar DepressionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will be performed as a 3-month randomized control cross-over study. The participants will be adults (19 years and older). New participants may enter the study at any time and will be randomized into either the practice group or the control group. The practice group will start practices at the baseline zero time point and will stop their practices at the 6-weeks time point. The control group will crossover to the practice group at the 6-weeks time point and will stop practices at the 12-weeks time point. The study will evaluate the effects of mindfulness practice using these standardized questionnaires: * the SF-36 Quality of Life questionnaire, * the PHQ-9 Questionnaire and * the BAI-21 Beckman Anxiety Inventory All participants will complete the set of all three questionnaires upon entry into the study - the baseline zero time point; and again, at the 6-weeks and the 12-weeks time points.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sha Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Hudoba De Badyn, MD, FRCS,, Principal investigator, Sha Research FoundationLaurie Omuro-Yamamoto, PhD, Principal investigator, Satori Family Wellness Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934330
- Sponsor's protocol ID
- Pro00050084
- Status last verified
- Aug 2026
- First submitted
- 11 Apr 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share the protocol with the statistical analysis plan of the study, the mean change from baseline in the SF-36 Quality of Life Scores, the PHQ-9 Patient Health Questionnaire Scores and the BAI-21 Beckman Anxiety Inventory Scores after six weeks of mindfulness practices with Tao Art and energized water.
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.
PubMed 1593914Kao 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.
PubMed 29440902Kobau 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.
PubMed 21680918White 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.
PubMed 25749590Marikar 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.
PubMed 36908018Jamil 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.
PubMed 37476142Pascoe 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.
PubMed 35757358Poissant 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.
PubMed 31093302de 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.
PubMed 34366998de 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.
PubMed 33362637Kao 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.
PubMed 24611024Zhang 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.
PubMed 33884400Simpson 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.
PubMed 34140914Perry 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.
PubMed 36358382Spitzer 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.
PubMed 7966923
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tao Calligraphy Meditation and Energized Water on Depression Randomized Control Cross-over Study
- ClinicalTrials.gov ID
- NCT06934330
- Acronym / sponsor ID
- Pro00050084
- Conditions
- Unipolar Depression
- Keywords
- Unipolar Depression, Well-being, SF 36 Quality of life questionnaire, PHQ-9 questionnaire, Tao Calligraphy, Healing Art, Chinese Calligraphy, BAI-21 Beckman Anxiety Inventory
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sha Research FoundationUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 18 Apr 2025 (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 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be performed as a 3-month randomized control cross-over study. The participants will be adults (19 years and older). New participants may enter the study at any time and will be randomized into either the practice group or the control group. The practice group will start practices at the baseline zero time point and will stop their practices at the 6-weeks time point. The control group will crossover to the practice group at the 6-weeks time point and will stop practices at the 12-weeks time point. The study will evaluate the effects of mindfulness practice using these standardized questionnaires: * the SF-36 Quality of Life questionnaire, * the PHQ-9 Questionnaire and * the BAI-21 Beckman Anxiety Inventory All participants will complete the set of all three questionnaires upon entry into the study - the baseline zero time point; and again, at the 6-weeks and the 12-weeks time points.
| Arm | Type | Receives |
|---|---|---|
| Practice Group | Experimental | Behavioral: Mindfulness practice with Tao Art (Calligraphy and Song Greatest Love), Other: Drinking Energized waterThe 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Mindfulness practice with Tao Art (Calligraphy and Song Greatest Love)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. | Behavioural | Practice Group |
| Drinking Energized waterParticipants 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. | Other | Practice Group |
Primary outcome
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: 1. limitations in physical activities; 2. limitations in social activities; 3. limitations in usual role activities; 4. bodily pain; 5. general mental health (psychological distress and well-being); 6. limitations in usual role activities because of emotional problems; 7. vitality (energy and fatigue); 8. general health perceptions. 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.
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: * Scores ranging from 1-4 = minimal depression. * Scores ranging from 5-9 = mild depression. * Scores ranging from 10-14 = moderate depression. * Scores ranging from 15-19 = moderately severe depression. * Scores ranging from 20-27 = severe depression.
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: * Scores ranging from 1-10 = normal ups and downs. * Scores ranging from 11-16 = mild mood disturbance. * Scores ranging from 17-20 = borderline depression. * Scores ranging from 21-30 = moderate depression. * Scores ranging from 31-40 = severe depression. * Scores ranging from 40-63 = extreme depression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Results publication: PubMed 1593914Ware 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.
- Results publication: PubMed 29440902Kao 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.
- Results publication: PubMed 21680918Kobau 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.
- Results publication: PubMed 25749590White 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.
- Results publication: PubMed 36908018Marikar 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.
- Results publication: PubMed 37476142Jamil 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.
- Results publication: PubMed 35757358Pascoe 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.
- Results publication: PubMed 31093302Poissant 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.
- Results publication: PubMed 34366998de 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.
- Results publication: PubMed 33362637de 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.
- Results publication: PubMed 24611024Kao 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.
- Results publication: PubMed 33884400Zhang 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.
- Individual participant dataSharing planned: Yes. Investigators will share the protocol with the statistical analysis plan of the study, the mean change from baseline in the SF-36 Quality of Life Scores, the PHQ-9 Patient Health Questionnaire Scores and the BAI-21 Beckman Anxiety Inventory Scores after six weeks of mindfulness practices with Tao Art and energized water.
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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.
Peter Hudoba De Badyn, MD, FRCS, principal investigator
Sha Research Foundation
Laurie Omuro-Yamamoto, PhD principal investigator
Satori Family Wellness Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness practice with Tao Art (Calligraphy and Song Greatest Love) and Drinking Energized water in people with Unipolar Depression, run by Sha Research Foundation 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
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.). The study lists 3 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 NCT06934330, which also lists 23 linked publications.
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 6 Aug 2026.