Effects of Peer Support and Yoga Music on T2DM With Depression and Sleep Disorders
NCT ID: NCT02198989
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2014-01-31
2014-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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peer support and yoga music therapy
Patients in the group will receive peer support and yoga music therapy before bed.
Patients in the group will received the group education courses and clinical medical therapy.
peer support and yoga music therapy
Patients in the intervention group will receive peer support and yoga music therapy before bed.
Control group
Patients in the group will received the group education courses and clinical medical therapy.
No interventions assigned to this group
Interventions
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peer support and yoga music therapy
Patients in the intervention group will receive peer support and yoga music therapy before bed.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis type 2 diabetes more than 6 months
* 40 Years to 84 Years old
* Sleep-disordered patients (PSQI scores≥7)
* Mild depression condition（14 ≥PHQ-9 scores≥ 5 分）
* Have a stable T2DM condition，without any other diseases affect patients' sleep
* Agree to participate in the study and have signed the Inform Consent Form
Exclusion Criteria
* Hearing loss or severe visual disorder
* Life expectancy is less than 12 months
* Primary sleep apnoea syndrome
* Serious physical pain that affect the quality of sleep
* Using drugs that affect the quality of sleep
* Individuals with histories of Alcohol or Drug Abuse
* Patients with high risk for sleep apnea syndrome(STOP scores ≥3 )
* Planned to receive selective surgery within 3months
* Observed mental confusion suggesting dementia
* Ongoing psychiatric care
* Paralysis or residence in a long-term care facility
40 Years
84 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Guang Ning
OTHER
Responsible Party
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Guang Ning
Shanghai Jiao Tong University School of Medicine
Principal Investigators
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Liebin Zhao, MSM
Role: STUDY_CHAIR
Center of Diabetes, Ruijin Hospital, Shanghai Jiao Tong University of Medicine
Locations
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Shanghai Jiao Tong University of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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CCEMD-022
Identifier Type: -
Identifier Source: org_study_id