Effect of Tao Calligraphy Meditation and Energized Water on Depression Randomized Control Cross-over Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Mean Change from Baseline in Quality of Life Scores on 36-item short-form Quality of Life Questionnaire (SF-36) at 6 weeks
Study Overview
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:
- 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Practice Group
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.
Intervention: Mindfulness practice with Tao Art (Calligraphy and Song Greatest Love) (Behavioral)
Practice Group
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.
Intervention: Drinking Energized water (Other)
Control Group
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported