Pilot Study of Breath Awareness with Pyramid to Reduce Anxiety and Depression in Adults with Type 2 Diabetes

What this Trial Is About

This research aims to evaluate the impact of breath awareness combined with pyramid energy on symptoms of depression and anxiety in people with type 2 diabetes mellitus T2DM. The study addresses the high prevalence of psychological distress in T2DM patients, noting the bidirectional relationship between depression and diabetes. Mindfulness-based interventions like breath awareness and yoga have shown promise in reducing psychological disorders, and this study explores whether practicing breath awareness with a pyramid-shaped device can further enhance mental health and glycemic control. Participants will be randomly assigned to either an intervention group or a control group. The intervention group receives 1 to 2 hours of daily training for six weeks on breath awareness using a pyramid-shaped head cap, guided by a certified trainer. This training includes breath awareness techniques, group discussions on mindful living, and wisdom sharing. The control group continues their usual care recommended by their physicians and will receive breath awareness training after the study ends. The study lasts a total of 12 weeks, with follow-up assessments at 6 and 12 weeks. Participants will undergo evaluations at baseline, 6 weeks, and 12 weeks, including questionnaires measuring anxiety, depression, sleep quality, stress, mindful attention, and quality of life. Blood samples will be collected to assess glycemic control HbA1c, cortisol, lipid profiles, thyroid function, and inflammatory markers. Compliance is monitored through attendance logs. The primary outcomes are changes in anxiety and depression scores at 6 weeks, while secondary outcomes include changes in quality of life and biomarkers. The study follows strict data management and confidentiality procedures throughout the trial.

A Pilot Study to Assess the Impact of Breath Awareness Using Pyramid on Symptoms of Anxiety and Depression in People with T2DM