An interventional study of Breath Awareness using pyramid in Depression, Anxiety, sponsored by Dasman Diabetes Institute. Completed at 1 site in Kuwait. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Dasman Diabetes Institute · Not applicable, Interventional, and Supportive care
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.
Hypothesis of the study is whether the combination of breath awareness and pyramid energy will
This is a randomized controlled trial study to assess the effect of pyramid breath awareness on people with T2DM and symptoms of depression. Eligible participants will be randomly assigned to either the interventional group or the waitlisted group (control group) in a ratio of 1:1. The participants in the intervention group will be provided with a training session on breath awareness using a pyramid head cap. Participants in the waitlisted group (control group) will be following the usual care recommended by the physician. However, breath awareness training will be given to the waitlist group after the study.Hospital Anxiety and Depression Scale (HADS), the Patient Health Questionnaire (PHQ-9), the Perceived Stress Scale, Diabetes Quality of Life (DQoL), the Pittsburgh Sleep Quality Index (PSQI), and the Mindful Attention Awareness Scale (MAAS) at baseline, 6th week and 12th week. 12 ml of blood will be drawn from the participants of both groups by a trained phlebotomist. Participants in the intervention group will be provided with breath awareness training by a certified breath awareness trainer. Participants will be instructed to be aware of their breath by placing the pyramid cap on their head. Apart from breath awareness technique, group discussion on healthy, mindful living, and wisdom sharing will be carried out by the trainer. A total of 1 to 2 hours of daily sessions will be provided to the participants until 6 weeks at DDI or online as preferred by them, followed up until 12 weeks later. The compliance rate of participants will be monitored using an attendance log. Participants glycaemic control (HbA1C), cortisol, lipid profile, TSH, complete clinical report, and other inflammatory biomarkers will be measured at three intervals, baseline, 6th week, and 12th week.
Statistical method: Sample Size Calculation: Based on the previous studies and a prevalence of 29 % depression in the state of Kuwait, sample size of 76 is considered for the pilot study. 25% more will be recruited to account for dropouts and defaulter. Data management: Data will be collected by a trained research team and will be entered into the REDCAP with proper scrutiny and quality checks.The data will be kept confidential, and the team will ensure good documentation and assure to comply with good clinical practices. The team members are GCP trained and will undergo online training provided by CITI.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 20 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Dasman Diabetes Institute is the lead sponsor of 31 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: • More than 1 year of T2DM diagnosis
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Breath Awareness using pyramid in people with T2DM and symptoms of depression and anxiety
Behavioral: Breath Awareness using pyramid
Control group or the wait list group will continue usual treatment recommended by the physician.
Participants are provided 1-2 hr training for 6 weeks on bringing breath awareness to the present moment using a pyramid
Also known as: mindfulness
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).
Time frame: 6 weeks
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)
Time frame: 6 weeks
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
Time frame: 6 weeks
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
Time frame: 6 weeks
Change in Diabetes Quality of Life (Diabetes 39)
DQoL score is measured at baseline and in 6th week to assess the quality of life.
Time frame: 6 weeks
Change in HbA1C
HbA1c is measured at baseline and in 6th week to assess the glycemic control
Time frame: 6 weeks
Change in cortisol levels
Serum cortisol level is measured at baseline and in 6th week to assess the stress indicator
Time frame: 6 weeks
Ran from Nov 2024 to primary completion in Feb 2025, 3 months.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 3 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Dasman Diabetes Institute