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

NCT ID: NCT06632782

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-12-31

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 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.

Conditions

Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

intervention

Breath Awareness using pyramid in people with T2DM and symptoms of depression and anxiety

Group Type: EXPERIMENTAL

Breath Awareness using pyramid

Intervention Type: BEHAVIORAL

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

control

Control group or the wait list group will continue usual treatment recommended by the physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

mindfulness

Eligibility Criteria

Inclusion Criteria

• 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.
• Able to be aware of breath and provide written informed consent.

Exclusion Criteria

• T1DM patients
• On antidepressant drugs
• Bipolar disorders
• Any acute coronary events in the past 6 months
• Any acute renal diseases including transplant or dialysis.
• Artificial pacemaker
• Any breath awareness or yoga course within 6 months.
• Pregnancy

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dasman Diabetes Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rashmi Shiju

Role: PRINCIPAL_INVESTIGATOR

Dasman Diabetes Institute

Locations

Dasman Diabetes Institute

Kuwait City, Kuwait, Kuwait

Site Status: RECRUITING

Countries

Kuwait

Central Contacts

Rashmi Shiju, MPharmacy

Role: CONTACT

rashmi.shiju@dasmaninstitute.org

22242999 ext. 2303

Abdullah Bennakhi, MD

Role: CONTACT

abdullah.bennakhi@dasmaninstitute.org

22242999 ext. 3101

Facility Contacts

Rashmi Shiju, MPharmacy

Role: primary

rashmi.shiju@dasmaninstitute.org

22242999 ext. 2303

Abdullah Bennakhi, MD

Role: backup

abdullah.bennakhi@dasmaninstitute.org

22242999 ext. 3102

Other Identifiers

RA HM 2023-001

Identifier Type: -

Identifier Source: org_study_id