Effect of Tao Calligraphy Meditation and Energized Water on Depression
ConditionUnipolar Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSha Research Foundation
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Not meeting any of the inclusion criteria
Bipolar disorders, schizophrenia (psychosis)
Treatment with highly potent neuroleptics
Unwillingness to participate in data gathering
Trial design
Design model
Crossover
Treatments tested in this trial
Mindfulness practice with Tao Art (Calligraphy and Song Greatest Love)
BehavioralDuring 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 water
Other interventionParticipants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Practice GroupExperimental treatment 2 interventions
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
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.2
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.
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.3
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.
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.Sponsors and contacts
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Source ClinicalTrials.gov