RecruitingNot ApplicableNCT06632782

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


Sponsor

Dasman Diabetes Institute

Enrollment

152 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Diabetes mellitus is rampant in the Middle East. It is a psychologically and behaviorally demanding disease; psychosocial factors are relevant to nearly all aspects of its management. Moreover, depression and diabetes are bidirectionally connected. Those with depression are at risk of developing diabetes and those with comorbid diabetes are at risk of developing depressive symptoms. Research findings have demonstrated that depression and anxiety are more common in patients with diabetes than in the general population, atleast 15 % have clinical depression. In addition, the recent COVID- 19 pandemic has fueled the burden by increasing fear, anxiety, and depression among people with T2DM due to susceptibility to long-term complications. In Kuwait, a recent survey found the prevalence of depression to be 29% and diabetes distress to be 14%. Thus, there is a dire need to address this challenging problem. In the recent past, mindfulness-based intervention such as Mindfulness-based stress reduction (MBSR), Mindfulness-based cognitive therapy (MBCT,) and yoga have emerged as unique tools for reducing a wide range of psychological disorders. These tools positively impact hormone regulation and have a beneficial effect on cognitive function and increased parasympathetic activity. The positive impact of mindfulness is assumed to be amplified if a pyramid structure with geometry similar to the pyramid of Giza is used for practice. Not much human research has been performed to demonstrate that pyramid energy along with mindfulness can be a tool to combat psychological disorders. However, few studies on animal models provided evidence of the potential beneficial effect of pyramid structure in reducing stress. Previous pilot study conducted using only yoga as an intervention indicated significant improvement in anxiety, depression, and quality of life in people with T2DM. However, there was no change in participants' glycemic control. In this pilot study, investigator will assess whether pyramid breath awareness can alleviate symptoms of depression and anxiety in people with T2DM.


Eligibility

Min Age: 30 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a breathing awareness exercise using a pyramid structure to help people with type 2 diabetes manage symptoms of anxiety and depression. Living with diabetes can significantly affect mental health, and this pilot study explores whether this simple, non-drug approach can improve emotional wellbeing. **You may be eligible if...** - You have had type 2 diabetes for more than 1 year - Your blood sugar (HbA1c) is between 5.7% and 9.5% - You are over 30 years old and taking diabetes medications (pills or insulin) - You score 8 or above on anxiety and depression questionnaires - You have no known heart problems - You are able to focus on your breathing and provide written consent **You may NOT be eligible if...** - You have type 1 diabetes - You are currently taking antidepressant medications - You have bipolar disorder - You had a heart attack or acute heart event in the last 6 months - You have acute kidney disease, are on dialysis, or have had a kidney transplant - You have an artificial pacemaker - You are pregnant - You have done breathing awareness or yoga in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALBreath Awareness using pyramid

Participants are provided 1-2 hr training for 6 weeks on bringing breath awareness to the present moment using a pyramid


Locations(1)

Dasman Diabetes Institute

Kuwait City, Kuwait, Kuwait

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NCT06632782


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