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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Kuwait
Dasman Diabetes Institute
RECRUITING
Kuwait City
Contact Information
Primary
Rashmi Shiju, MPharmacy
rashmi.shiju@dasmaninstitute.org
22242999
Backup
Abdullah Bennakhi, MD
abdullah.bennakhi@dasmaninstitute.org
22242999
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 152
Treatments
Experimental: intervention
Breath Awareness using pyramid in people with T2DM and symptoms of depression and anxiety
No_intervention: control
Control group or the wait list group will continue usual treatment recommended by the physician.
Related Therapeutic Areas
Sponsors
Leads: Dasman Diabetes Institute

This content was sourced from clinicaltrials.gov