Tao Calligraphy + Energized Water for Depression

Overseen By Cynthia Hamilton, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sha Research Foundation

Must not be taking: Neuroleptics

Disqualifiers: Bipolar, Schizophrenia, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those on highly potent neuroleptics, so you may need to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment Tao Calligraphy + Energized Water for Depression?

Research shows that mindfulness practices can help reduce symptoms of depression by lowering inflammation markers and decreasing negative thoughts. Mindfulness-based interventions have been effective in reducing depressive symptoms and preventing relapse in people with depression. ^{1 2 3 4 5}

How does the Tao Calligraphy + Energized Water treatment for depression differ from other treatments?

This treatment is unique because it combines mindfulness practices with Tao Art, specifically using calligraphy and song, which is not a common approach in traditional depression treatments. It focuses on holistic healing by integrating art and mindfulness, offering a novel way to address depression beyond conventional medication or therapy. ^{1 6 7 8 9}

Research Team

Peter Hudoba De Badyn, MD, FRCS,

Principal Investigator

Sha Research Foundation

Laurie Omuro-Yamamoto, PhD

Principal Investigator

Satori Family Wellness Center

Eligibility Criteria

This trial is for adults with Unipolar Depression who are interested in alternative treatments. Participants should be willing to practice Tao Calligraphy Mindfulness for at least 30 minutes and drink Energized water daily for a minimum of five minutes. Details on specific inclusion or exclusion criteria were not provided.

Inclusion Criteria

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 by Sha Research Foundation

I am 19 or older and have been diagnosed with depression by a doctor.

Exclusion Criteria

Serious mental disorders (e.g., schizophrenia)

I am not willing to share my medical data for research.

Not meeting any of the inclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants practice mindfulness techniques with Tao Calligraphy and drink energized water for six weeks

6 weeks

Baseline, 6-week, and 12-week assessments

Crossover Treatment

Control group participants crossover to practice mindfulness techniques with Tao Calligraphy and drink energized water for six weeks

6 weeks

6-week and 12-week assessments

Follow-up

Participants are monitored for changes in depression and anxiety symptoms after treatment

4 weeks

Treatment Details

Interventions

• Drinking Energized water
• Mindfulness practice with Tao Art (Calligraphy and Song Greatest Love)

Trial Overview The study tests if Tao Calligraphy Mindfulness and drinking Energized water can improve symptoms of depression. It measures changes using the SF-36, PHQ-9, and BAI-21 questionnaires over six weeks, comparing results from before starting the practices to after.

Participant Groups

Group I: Practice Group Experimental Treatment 2 Interventions

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.

Group II: Control Group Active Control 1 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 Is Running the Clinical Trial?

Sha Research Foundation

Lead Sponsor

Trials

2

Recruited

60+

Findings from Research

Mind-body interventions significantly reduced depressive symptoms in older Chinese adults, showing a large short-term effect size of -1.41 based on a systematic review of 14 randomized controlled trials.

Most studies did not evaluate the long-term effects of these interventions, indicating a need for further research to understand their lasting impact on depression in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mind-body interventions on depressive symptoms among older Chinese adults: a systematic review and meta-analysis. Bo, A., Mao, W., Lindsey, MA.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of mind-body interventions on depressive symptoms among older Chinese adults: a systematic review and meta-analysis. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

The correlation between mindfulness and negative automatic thoughts in depression patients. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Brief mindfulness training reduces salivary IL-6 and TNF-α in young women with depressive symptomatology. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Relapse prevention in major depressive disorder: Mindfulness-based cognitive therapy versus an active control condition. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for major depressive disorder: A comprehensive meta-analysis of randomized controlled trials. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Multimodal mind/body group therapy for chronic depression: a pilot study. [2009]

7. United States pubmed.ncbi.nlm.nih.gov

A Breathing-Based Meditation Intervention for Patients With Major Depressive Disorder Following Inadequate Response to Antidepressants: A Randomized Pilot Study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Treatment of Major Depressive Disorder with Iyengar Yoga and Coherent Breathing: A Randomized Controlled Dosing Study. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Flow With Nature Treatment for Depression: Participants' Experiences. [2022]