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

NCT06632782 | Recruiting

• 1 other identifier: RA HM 2023-001
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Anxiety

Keywords

depression

Outcome Measures

Primary Outcomes (4)

• 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).

  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)

  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

  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

  6 weeks

Secondary Outcomes (3)

• Change in Diabetes Quality of Life (Diabetes 39)

  6 weeks

• Change in HbA1C

  6 weeks

• Change in cortisol levels

  6 weeks

Study Arms (2)

intervention

EXPERIMENTAL

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

Behavioral: Breath Awareness using pyramid

control

NO INTERVENTION

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

Interventions

Breath Awareness using pyramid BEHAVIORAL

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

intervention

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dasman Diabetes Institute: lead

Study Sites (1)

Dasman Diabetes Institute

Kuwait City, Kuwait, 15462, Kuwait

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rashmi Shiju

  Dasman Diabetes Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rashmi Shiju, MPharmacy

CONTACT

22242999; rashmi.shiju@dasmaninstitute.org

Abdullah Bennakhi, MD

CONTACT

22242999; abdullah.bennakhi@dasmaninstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Masking of participants is not possible in such alternative intervention
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled participants will be randomized to the intervention and control group.

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

KU (1)