Mindfulness Practice for Stress and Social Connectedness

Overseen By Cynthia Hamilton, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sha Research Foundation

Disqualifiers: Pregnant, Nursing, Serious mental disorders

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

Compensation: Varies

Number of Visits: 4

Duration: 3 months

50 Participants Needed

Trial Summary

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. It seems focused on mindfulness practices, so you may not need to change your medication routine, but it's best to confirm with the study coordinators.

What data supports the effectiveness of the treatment Mindfulness practice with Tao Art (Calligraphy and Song Love Peace and Harmony) for stress and social connectedness?

Research shows that mindfulness-based stress reduction and art-based therapies can improve well-being, reduce stress, and enhance quality of life in cancer patients. These findings suggest that combining mindfulness with art, like calligraphy and song, may also help reduce stress and improve social connections. ^{1 2 3 4 5}

Is mindfulness practice generally safe for humans?

Mindfulness practices, including those used in various interventions, are generally considered safe, but some studies report possible side effects like mental and physical health consequences. It's important for participants to be screened properly to minimize risks. ^{6 7 8 9 10}

How is the treatment 'Mindfulness practice with Tao Art' unique for stress and social connectedness?

This treatment is unique because it combines mindfulness with Tao Art, including calligraphy and song, which may enhance emotional and spiritual well-being through creative expression, unlike traditional mindfulness practices that focus solely on meditation. ^{1 11 12 13 14}

What is the purpose of this trial?

The Effects of Mindfulness Practice with Tao Art ("Love Peace Harmony" Calligraphy and Song) on Well-being - Controlled Randomized Study The goal of this controlled randomized clinical study is to learn if a Tao Calligraphy Mindfulness Practice works to improve Well-being. The main questions it aims to answer are: * Does Tao Calligraphy Mindfulness practice improve these three aspects of well-being in adults: (1) Perceived Stress, (2) the Social Connectedness, and (3) Peace of Mind? * Will any improvement in the Perceived Stress Scale (PSS), the Social Connectedness Scale (SCS), and the Peace of Mind Scale (PMS) in adults be statistically significant? Investigators will compare the values of these three scales at the beginning of the mindfulness practices to their values at three months of practice and control groups. Participants will: * be randomized into practice and wait-list control groups * complete the set of three questionnaires upon entry into the study - (the baseline or zero time point; at the 3-months time point, and at the six-months time point * practice the mindfulness techniques with Tao Calligraphy and Tao Song for a minimum of thirty minutes daily

Research Team

Marsha Valutis, PhD

Principal Investigator

Sha Research Foundation

Peter Hudoba De Badyn, MD, FRCS

Principal Investigator

Sha Research Foundation

Eligibility Criteria

This trial is for adults interested in improving their well-being through mindfulness. Participants should be willing to practice Tao Calligraphy Mindfulness, which involves calligraphy and song, for at least 30 minutes daily. The study will exclude individuals who do not meet the inclusion criteria set by the researchers.

Inclusion Criteria

I am 19 years old or older.

I am willing and able to follow the study's data collection rules.

Submission of required documentation before entering into the study, including informed consent and consent to release of information

Exclusion Criteria

Not meeting any of the inclusion criteria

I can't commit to daily 30-minute mindfulness practices.

Pregnant or nursing. Participants who become pregnant during the study will be required to end their participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants practice mindfulness with Tao Calligraphy and Song for at least 30 minutes daily

3 months

3 visits (in-person) at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for changes in well-being through questionnaires

3 months

1 visit (in-person) at 6 months

Treatment Details

Interventions

• Mindfulness practice with Tao Art (Calligraphy and Song Love Peace and Harmony)

Trial Overview The trial tests if practicing Mindfulness with Tao Art (Calligraphy and Song) can enhance social connectedness, peace of mind, and reduce stress over a period of three months. It's a controlled randomized study where participants are divided into two groups: one practices daily while the other is on a wait-list.

Participant Groups

Group I: Wait-list Control Group Experimental Treatment 1 Intervention

The Wait-list Control group will crossover to become Practice group at the 3-months time point. Participants will start practices at the 3-months time point and will stop practices after three months at 6-months time point. All participants in Wait-list Group will complete the set of all three questionnaires upon entry into the study at baseline zero time point; at 3-months time-point and at 6-months time point.

Group II: Practice Group Experimental Treatment 1 Intervention

The Practice group will start practices at baseline zero time point and will stop practices after three months at the 3-months time point. Participants in the Practice group will practice Mindfulness practice with Calligraphy at least 30 minutes daily for three months. 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 3-months time point and at the 6-months time point.

Who Is Running the Clinical Trial?

Sha Research Foundation

Lead Sponsor

Trials

2

Recruited

60+

Findings from Research

In a study involving 104 cancer patients, both mindfulness-based stress reduction (MBSR) and healing through the creative arts (HA) programs significantly improved post-traumatic growth over time.

Participants in the MBSR program showed greater improvements in spirituality, anxiety, anger, overall stress symptoms, and mood disturbance compared to those in the HA program, suggesting MBSR may be more effective for emotional well-being in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A non-randomized comparison of mindfulness-based stress reduction and healing arts programs for facilitating post-traumatic growth and spirituality in cancer outpatients. Garland, SN., Carlson, LE., Cook, S., et al.[2022]

Mindfulness-based stress reduction training significantly improved quality of life and reduced physical symptoms in 47 cancer patients, with benefits observed immediately after training and even stronger effects reported one year later.

Participants experienced decreased mood disturbances, such as depression and anger, indicating that mindfulness training can help cancer patients manage stress and enhance their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training for oncology patients: patients' appraisal and changes in well-being. Kieviet-Stijnen, A., Visser, A., Garssen, B., et al.[2008]

Mindfulness meditation (MM) can have side effects, particularly related to mental health, physical health, and spiritual well-being, highlighting the need for safety considerations in research.

The paper provides practical tools for researchers, including screening procedures to assess participant contraindications and guidelines for MM training, based on a review of 17 primary studies and 5 secondary reports on meditation side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. Lustyk, MK., Chawla, N., Nolan, RS., et al.[2022]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

A brief mindfulness-based stress reduction program significantly improved nursing students' attitudes towards medical errors and reduced the number of medical errors made in a simulation environment, based on a study of 78 third-year nursing students.

While the program enhanced awareness of medical errors, it did not significantly affect self-confidence or satisfaction levels among the students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a brief mindfulness-based stress reduction program on strengthening awareness of medical errors and risks among nursing students. Tarhan, M., Elibol, E.[2023]

In a 21-day mindfulness-based intervention with 82 participants, 87% reported at least one momentary adverse effect during meditation, primarily anxiety, indicating that mindfulness practice can sometimes lead to temporary increases in anxiety.

Despite these momentary effects, 25% of participants experienced sustained adverse effects in daily life after the intervention, but these were not linked to the momentary effects during meditation, suggesting that increased awareness of internal states may contribute to these post-intervention challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. Aizik-Reebs, A., Shoham, A., Bernstein, A.[2021]

Mindfulness and compassion practices, such as focus and insight meditation, are effective in reducing stress among healthcare professionals, helping them manage emotional distress and improve emotional regulation.

Training in mindfulness and compassion can transform empathy into compassion, which may counteract empathy fatigue and enhance self-care, making group training in healthcare settings a beneficial approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevent burnout in health care with mindfulness and compassion]. Yu, W.[2019]

A brief online mindfulness-based intervention significantly improved mindfulness and reduced psychological distress among 51 Chinese residents during the COVID-19 pandemic, with strong statistical evidence for its effectiveness across various psychological symptoms.

The study demonstrated significant between-group treatment effects, indicating that participants in the mindfulness group experienced greater reductions in anxiety, depression, and somatic symptoms compared to the waitlist control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Online Mindfulness-Based Group Intervention for Psychological Distress Among Chinese Residents During COVID-19: a Pilot Randomized Controlled Trial. Zhang, H., Zhang, A., Liu, C., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

A non-randomized comparison of mindfulness-based stress reduction and healing arts programs for facilitating post-traumatic growth and spirituality in cancer outpatients. [2022]

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

Mindfulness-based stress reduction and health-related quality of life: findings from a bilingual inner-city patient population. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training for oncology patients: patients' appraisal and changes in well-being. [2008]

4. England pubmed.ncbi.nlm.nih.gov

Psychosocial benefits of a novel mindfulness intervention versus standard support in distressed women with breast cancer. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Effects of art-based mandala intervention on distress and anxiety in cancer patients. [2021]

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

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. [2022]

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

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]

8. Scotland pubmed.ncbi.nlm.nih.gov

The effect of a brief mindfulness-based stress reduction program on strengthening awareness of medical errors and risks among nursing students. [2023]

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

Who benefits from mindfulness? The moderating role of personality and social norms for the effectiveness on psychological and physiological outcomes among police officers. [2020]

10. England pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. [2021]

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

Remote delivery of a Koru Mindfulness intervention for college students during the COVID-19 pandemic. [2022]

12. Sweden pubmed.ncbi.nlm.nih.gov

[Prevent burnout in health care with mindfulness and compassion]. [2019]

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

Dancing Mindfulness: A Phenomenological Investigation of the Emerging Practice. [2015]

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

A Brief Online Mindfulness-Based Group Intervention for Psychological Distress Among Chinese Residents During COVID-19: a Pilot Randomized Controlled Trial. [2022]