Effect of Tao Calligraphy Meditation and Energized Water on Depression

NCT06934330 | Recruiting DMC

• 1 other identifier: Pro00050084
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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: 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.

  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.

  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.

  From start of Mindfulness practices with Tao Art (Calligraphy and Song Greatest Love) and drinking energized water to end of practices at 6 weeks.

Study Arms (2)

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.

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.

Interventions

Mindfulness practice with Tao Art (Calligraphy and Song Greatest Love) BEHAVIORAL

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.

Practice Group

Drinking Energized water OTHER

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.

Practice Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sha Research Foundation: lead

Study Sites (1)

Satori Family Wellness Center

Kahului, Hawaii, 96732, United States

RECRUITING

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MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Peter Hudoba De Badyn, MD, FRCS,

  Sha Research Foundation

  PRINCIPAL INVESTIGATOR

• Laurie Omuro-Yamamoto, PhD

  Satori Family Wellness Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Hudoba De Badyn, MD, FRCS,

CONTACT

604-904-7712; sharesearchfoundation@yahoo.ca

Cynthia Hamilton, PhD

CONTACT

778 847-3617; cynthialhamiltonconsulting@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: February 10, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): January 10, 2027
• Last Updated: April 28, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: Anyone with an active account at this platform.

Locations

US (1)