Actively Recruiting
A Pilot Study to Assess Breath Awareness Using Pyramid on Anxiety and Depression Symptoms in People with Type 2 Diabetes
Led by Dasman Diabetes Institute · Updated on 2024-10-18
152
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Pilot Study to Assess the Impact of Breath Awareness Using Pyramid on Symptoms of Anxiety and Depression in People with T2DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes mellitus for more than 1 year
- HbA1c between 5.7% and 9.5%
- Age between 30 and 80 years
- Currently on oral diabetes medication or insulin
- No cardiac problems
- Anxiety or depression score of 8.0 or higher on questionnaires
- Able to perform breath awareness and provide written informed consent
You will not qualify if you...
- Diagnosis of type 1 diabetes mellitus
- Currently taking antidepressant medications
- Presence of bipolar disorder
- Any acute coronary event in the past 6 months
- Acute kidney disease including transplant or dialysis
- Having an artificial pacemaker
- Participation in breath awareness or yoga courses within the past 6 months
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants in the intervention group receive 1 to 2 hours of daily breath awareness training using a pyramid head cap for 6 weeks, including group discussions on healthy, mindful living and wisdom sharing. The control group continues their usual care recommended by their physician during this period.
Daily sessions for up to 6 weeks
Duration - 6 weeks
Participants are followed up until 12 weeks from the start of the study to assess ongoing effects and collect outcome measures.
Visits at 6th week and 12th week for assessments
Trial Site Locations
Total: 1 location
1
Dasman Diabetes Institute
Kuwait City, Kuwait, Kuwait, 15462
Actively Recruiting
Research Team
R
Rashmi Shiju, MPharmacy
A
Abdullah Bennakhi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here