Effects of Peer Support and Yoga Music on T2DM With Depression and Sleep Disorders
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
peer support and yoga music therapy
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Confirmed type 2 diabetes patients (ICD9) according to the medical record and patient's disease history
- 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:
- Terminal illnes
- 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
Sites / Locations
- Shanghai Jiao Tong University of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
peer support and yoga music therapy
Control group
Arm Description
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.
Patients in the group will received the group education courses and clinical medical therapy.
Outcomes
Primary Outcome Measures
Score on Pittsburgh Sleep Quality Index(PSQI)
Score on Patient Health Questionnaire (PHQ-9)
HbA1c
Secondary Outcome Measures
BMI
Insulin resistance measured as HOMA-IR
HOMA-IR = (FINS×FPG) / 22.5
Full Information
NCT ID
NCT02198989
First Posted
July 10, 2014
Last Updated
December 2, 2014
Sponsor
Guang Ning
Collaborators
Ruijin Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02198989
Brief Title
Effects of Peer Support and Yoga Music on T2DM With Depression and Sleep Disorders
Official Title
Effects of Peer Support and Yoga Music on T2DM With Depression and Sleep Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guang Ning
Collaborators
Ruijin Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
peer support and yoga music therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in the group will received the group education courses and clinical medical therapy.
Intervention Type
Behavioral
Intervention Name(s)
peer support and yoga music therapy
Intervention Description
Patients in the intervention group will receive peer support and yoga music therapy before bed.
Primary Outcome Measure Information:
Title
Score on Pittsburgh Sleep Quality Index(PSQI)
Time Frame
9 months
Title
Score on Patient Health Questionnaire (PHQ-9)
Time Frame
9 month
Title
HbA1c
Time Frame
9 months
Secondary Outcome Measure Information:
Title
BMI
Time Frame
9 months
Title
Insulin resistance measured as HOMA-IR
Description
HOMA-IR = (FINS×FPG) / 22.5
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed type 2 diabetes patients (ICD9) according to the medical record and patient's disease history
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:
Terminal illnes
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liebin Zhao, MSM
Organizational Affiliation
Center of Diabetes, Ruijin Hospital, Shanghai Jiao Tong University of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Jiao Tong University of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
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Effects of Peer Support and Yoga Music on T2DM With Depression and Sleep Disorders
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