A pilot study to assess the impact of breath awareness using pyramid on symptoms of anxiety and depression in people with T2DM
NCT ID NCT06632782
First seen Sep 10, 2026 · Last updated Sep 10, 2026
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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20 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Feb 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dasman Diabetes Institute
Kuwait City, 15462, Kuwait
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