Type 2 Diabetes Clinical Trial
Official title:
Effects of Peer Support and Yoga Music on T2DM With Depression and Sleep Disorders
40 patients with Type 2 Diabetes Mellitus who also have sleep disorders and mild depression in the community will be recruited and stochastically divided into the intervention group and the control group. Both groups will take the same group education courses including DSME (Diabetes Self-management Education), psychological support, improvement in sleep. Patients in the intervention group will receive peer support and yoga music therapy before bed. The observation period will last for 6 months so as to evaluate the benefits of peer support and yoga music therapy in sleep quality improvement and glycemic control of type 2 diabetic patients with sleep disorders and mild depression.
Research Method:
This study is an open- label controlled randomized cluster trial with the sample size
estimated by the improvement of Pittsburgh Sleep Quality Index（PSQI） score. 40 eligible and
voluntary Type 2 diabetic patients will be recruited among the patients with health records
in the community. Baseline assessment such as demography, sleep quality, depression,
physical exam and biochemical index will be performed on the patients who will have signed
the informed consents.
The study will use the method of randomized to classify the enrolled units into 2 groups,
each group has 20 people. Both groups will receive regular diabetes medication and group
education courses including Diabetes Self-management Education(DSME), psychological support,
improvement in sleep. The intervention group will be under the guidance of two well-trained
peer supporters to carry out group activities. Each supporter will be in charge of 10-15
patients. Starting with peer support therapy in the first three months, the intervention
group will then take Yoga music therapy before bed for another three months and be given
support and guidance by the peer supporters.
Compare the baselines and variations of two group's sleep, depression, blood sugar and
related biochemical indicators, and self-management, life quality, medication and other
aspects at the third month and sixth month. The final evaluation will show the effect and
related influencing factors of peer support and yoga music therapy in helping Type 2
diabetic patients who have sleep disorders and mild depression to improve their sleep
quality.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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