Type 2 DiabetesNCT02198989
Effects of Peer Support and Yoga Music on T2DM With Depression and Sleep Disorders
A study testing peer support and yoga music therapy in people with Type 2 Diabetes, run by Guang Ning at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 84 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- peer support and yoga music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University of Medicine
Shanghai, Shanghai Municipality
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- peer support and yoga music therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peer support and yoga music therapyBehavioural
Patients in the intervention group will receive peer support and yoga music therapy before bed.
| Study group | Role | What they receive |
|---|---|---|
| peer support and yoga music therapy | Experimental | 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. Receives: Behavioral: peer support and yoga music therapy |
| Control group | No intervention | Patients in the group will received the group education courses and clinical medical therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Pittsburgh Sleep Quality Index（PSQI）
Measured: 9 months
Score on Patient Health Questionnaire (PHQ-9)
Measured: 9 month
HbA1c
Measured: 9 months
Secondary outcomes (2)
BMI
Measured: 9 months
Insulin resistance measured as HOMA-IR
HOMA-IR = (FINS×FPG) / 22.5
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang Ning
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital
- Responsible party
- Sponsor-investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
- Investigators
- Liebin Zhao, MSM, Study chair, Center of Diabetes, Ruijin Hospital, Shanghai Jiao Tong University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198989
- Sponsor's protocol ID
- CCEMD-022
- Status last verified
- Dec 2014
- First submitted
- 10 Jul 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peer Support and Yoga Music on T2DM With Depression and Sleep Disorders
- ClinicalTrials.gov ID
- NCT02198989
- Acronym / sponsor ID
- CCEMD-022
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Guang NingUniversity, hospital or other
- Collaborators
- Ruijin Hospital
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peer support and yoga music therapy | Experimental | Behavioral: peer support and yoga music therapyPatients 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. |
| Control group | No intervention | –Patients in the group will received the group education courses and clinical medical therapy. |
Who may qualify
- Ages
- 40 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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）
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peer support and yoga music therapyPatients in the intervention group will receive peer support and yoga music therapy before bed. | Behavioural | peer support and yoga music therapy |
Primary outcome
Score on Pittsburgh Sleep Quality Index（PSQI）
Time frame: 9 months
Score on Patient Health Questionnaire (PHQ-9)
Time frame: 9 month
HbA1c
Time frame: 9 months
2 secondary outcomes
BMI
Time frame: 9 months
Insulin resistance measured as HOMA-IR
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liebin Zhao, MSM study chair
Center of Diabetes, Ruijin Hospital, Shanghai Jiao Tong University of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peer support and yoga music therapy in people with Type 2 Diabetes, run by Guang Ning at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on Pittsburgh Sleep Quality Index（PSQI） (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.