Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632782
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
A Pilot Study to Assess the Impact of Breath Awareness Using Pyramid on Symptoms of Anxiety and Depression in People with T2DM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study to Assess the Impact of Breath Awareness Using Pyramid on Symptoms of Anxiety and Depression in People with T2DM
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAPD
Brief 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
Detailed Description:
Hypothesis of the study is whether the combination of breath awareness and pyramid energy will
Amplify the positive impact on mental health in people with T2DM
Impact the glycaemic control in people with T2DM Methodology Experimental Design
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 11 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 studyHospital 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 checksThe 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
Amplify the positive impact on mental health in people with T2DM
Impact the glycaemic control in people with T2DM Methodology Experimental Design
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 11 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 studyHospital 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 checksThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None