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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

NCT06632782 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2024-10-18

No results posted yet for this study

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.

Conditions

  • Depression, Anxiety

Interventions

BEHAVIORAL

Breath Awareness using pyramid

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

Sponsors & Collaborators

  • Dasman Diabetes Institute

    lead OTHER

Principal Investigators

  • Rashmi Shiju · Dasman Diabetes Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-11-01
Completion
2026-12-31

Countries

  • Kuwait

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06632782 on ClinicalTrials.gov