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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorDasman Diabetes Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: interventionExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

Change in HbA1C

HbA1c is measured at baseline and in 6th week to assess the glycemic control

Time frame
6 weeks
3

Change in cortisol levels

Serum cortisol level is measured at baseline and in 6th week to assess the stress indicator

Time frame
6 weeks

Other outcomes

Sponsors and contacts

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