Assessing breath awareness techniques for anxiety and depression in diabetes patients
A Pilot Study to Assess the Impact of Breath Awareness Using Pyramid on Symptoms of Anxiety and Depression in People with T2DM
NA · Dasman Diabetes Institute · NCT06632782
This study is testing if breath awareness techniques can help people with Type 2 Diabetes feel less anxious and depressed while also checking their blood sugar levels.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Dasman Diabetes Institute (other) |
| Locations | 1 site (Kuwait City, Kuwait) |
| Trial ID | NCT06632782 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of breath awareness using a pyramid cap on symptoms of anxiety and depression in individuals with Type 2 Diabetes Mellitus (T2DM). Participants will be randomly assigned to either an intervention group, receiving breath awareness training, or a control group, continuing their usual care. The study aims to evaluate both mental health outcomes and glycemic control through various validated questionnaires and blood tests at baseline, 6 weeks, and 12 weeks. The research addresses the high prevalence of depression and anxiety among T2DM patients, particularly exacerbated by the COVID-19 pandemic.
Who should consider this trial
Good fit: Ideal candidates are adults over 30 years old with a diagnosis of T2DM for more than a year and experiencing symptoms of anxiety and depression.
Not a fit: Patients with Type 1 Diabetes Mellitus, those on antidepressant medications, or individuals with certain acute medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mental health and glycemic control in patients with T2DM.
How similar studies have performed: While mindfulness-based interventions have shown promise in similar contexts, this specific approach using breath awareness and a pyramid cap is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • More than 1 year of T2DM diagnosis * T2DM with HbA1c greater than 5.7 and less than 9.5% * T2DM patients, age greater than 30 years and on oral hypoglycaemic agents or on insulin * No cardiac problems * Score 8.0 and above as per the anxiety and depression questionnaires. * Able to be aware of breath and provide written informed consent. Exclusion Criteria: * T1DM patients * On antidepressant drugs * Bipolar disorders * Any acute coronary events in the past 6 months * Any acute renal diseases including transplant or dialysis. * Artificial pacemaker * Any breath awareness or yoga course within 6 months. * Pregnancy
Where this trial is running
Kuwait City, Kuwait
- Dasman Diabetes Institute — Kuwait City, Kuwait, Kuwait (RECRUITING)
Study contacts
- Principal investigator: Rashmi Shiju — Dasman Diabetes Institute
- Study coordinator: Rashmi Shiju, MPharmacy
- Email: rashmi.shiju@dasmaninstitute.org
- Phone: 22242999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depression, Anxiety, depression