Clinical trial NCT06934330: Effect of Tao Calligraphy Meditation and Energized Water on Depression
Official title: Effect of Tao Calligraphy Meditation and Energized Water on Depression Randomized Control Cross-over Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Sha Research Foundation
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

Brief 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 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:

1. a decrease in the symptoms of their illness as perceived subjectively.
2. an improvement of the clinical status of their illness, as observed by their clinicians.
3. 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change from Baseline in Quality of Life Scores on 36-item short-form Quality of Life Questionnaire (SF-36) at 6 weeks
timeFrame: From start of Mindfulness practices with Tao Art (Calligraphy and Song Greatest Love) and drinking energized water to end of practices at 6 weeks.
measure: Mean Change from Baseline in Scores on PHQ-9 questionnaire at 6 weeks
timeFrame: From start of Mindfulness practices with Tao Art (Calligraphy and Song Greatest Love) and drinking energized water to end of practices at 6 weeks.
measure: Mean Change from Baseline in Scores on BAI-21 (Beck Anxiety Inventory) Scale at 6 weeks
timeFrame: From start of Mindfulness practices with Tao Art (Calligraphy and Song Greatest Love) and drinking energized water to end of practices at 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Kahului
country: United States
facility: Satori Family Wellness Center
state: Hawaii
Study officials:
affiliation: Sha Research Foundation
name: Peter Hudoba De Badyn, MD, FRCS,
role: PRINCIPAL_INVESTIGATOR
affiliation: Satori Family Wellness Center
name: Laurie Omuro-Yamamoto, PhD
role: PRINCIPAL_INVESTIGATOR
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