Actively Recruiting

Phase Not Applicable
Age: 30Years - 80Years
All Genders
NCT06632782

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

Led by Dasman Diabetes Institute · Updated on 2024-10-18

152

Participants Needed

1

Research Sites

112 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 30Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with type 2 diabetes mellitus for more than 1 year
  • HbA1c level between 5.7% and 9.5%
  • Age over 30 years
  • Currently on oral hypoglycaemic agents or insulin
  • No heart problems
  • Anxiety and depression questionnaire score of 8.0 or higher
  • Able to practice breath awareness and provide written informed consent
Not Eligible

You will not qualify if you...

  • Diagnosed with type 1 diabetes mellitus
  • Taking antidepressant medications
  • Diagnosed with bipolar disorder
  • Had acute coronary events within the past 6 months
  • Have acute kidney diseases including transplant or dialysis
  • Have an artificial pacemaker
  • Attended any breath awareness or yoga course within the past 6 months
  • Currently pregnant

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Dasman Diabetes Institute

Kuwait City, Kuwait, Kuwait, 15462

Actively Recruiting

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Research Team

R

Rashmi Shiju, MPharmacy

CONTACT

A

Abdullah Bennakhi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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