About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
T1DM patients
On antidepressant drugs
Bipolar disorders
Any acute coronary events in the past 6 months
Trial design
Parallel
Treatments tested in this trial
Breath Awareness using pyramid
BehavioralParticipants are provided 1-2 hr training for 6 weeks on bringing breath awareness to the present moment using a pyramid
Treatment groups
Trial outcomes
Primary outcomes
Change in Hospital Anxiety and depression score(HADS)
HADS is assessed at baseline and at 6th Week to assess anxiety and depression. A lower score indicates a better outcome(less than 8).
Change in Patient Health Questionnaire PHQ-9 score
PHQ-9 score is assessed at baseline and at 6th week to assess depression, lower score indicates a better outcome(less than 4)
Change in Pitssburgh Sleep Quality Index PSQI score
PSQI score is assessed at baseline and in 6th week to assess the sleep quality, less than 5 indicate better outcome
Change inMindful Attention Awareness Scale (MAAS)
MAAS score is measured at baseline and in 6th week to assess the mindfulness. Higher score indicate better outcome
Secondary outcomes
Change in Diabetes Quality of Life (Diabetes 39)
DQoL score is measured at baseline and in 6th week to assess the quality of life.
Change in HbA1C
HbA1c is measured at baseline and in 6th week to assess the glycemic control
Change in cortisol levels
Serum cortisol level is measured at baseline and in 6th week to assess the stress indicator
Sponsors and contacts
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