<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02198989</url>
  </required_header>
  <id_info>
    <org_study_id>CCEMD-022</org_study_id>
    <nct_id>NCT02198989</nct_id>
  </id_info>
  <brief_title>Effects of Peer Support and Yoga Music on T2DM With Depression and Sleep Disorders</brief_title>
  <official_title>Effects of Peer Support and Yoga Music on T2DM With Depression and Sleep Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guang Ning</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      40 patients with Type 2 Diabetes Mellitus who also have sleep disorders and mild depression&#xD;
      in the community will be recruited and stochastically divided into the intervention group and&#xD;
      the control group. Both groups will take the same group education courses including DSME&#xD;
      (Diabetes Self-management Education), psychological support, improvement in sleep. Patients&#xD;
      in the intervention group will receive peer support and yoga music therapy before bed. The&#xD;
      observation period will last for 6 months so as to evaluate the benefits of peer support and&#xD;
      yoga music therapy in sleep quality improvement and glycemic control of type 2 diabetic&#xD;
      patients with sleep disorders and mild depression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Method:&#xD;
&#xD;
      This study is an open- label controlled randomized cluster trial with the sample size&#xD;
      estimated by the improvement of Pittsburgh Sleep Quality Index（PSQI） score. 40 eligible and&#xD;
      voluntary Type 2 diabetic patients will be recruited among the patients with health records&#xD;
      in the community. Baseline assessment such as demography, sleep quality, depression, physical&#xD;
      exam and biochemical index will be performed on the patients who will have signed the&#xD;
      informed consents.&#xD;
&#xD;
      The study will use the method of randomized to classify the enrolled units into 2 groups,&#xD;
      each group has 20 people. Both groups will receive regular diabetes medication and group&#xD;
      education courses including Diabetes Self-management Education(DSME), psychological support,&#xD;
      improvement in sleep. The intervention group will be under the guidance of two well-trained&#xD;
      peer supporters to carry out group activities. Each supporter will be in charge of 10-15&#xD;
      patients. Starting with peer support therapy in the first three months, the intervention&#xD;
      group will then take Yoga music therapy before bed for another three months and be given&#xD;
      support and guidance by the peer supporters.&#xD;
&#xD;
      Compare the baselines and variations of two group's sleep, depression, blood sugar and&#xD;
      related biochemical indicators, and self-management, life quality, medication and other&#xD;
      aspects at the third month and sixth month. The final evaluation will show the effect and&#xD;
      related influencing factors of peer support and yoga music therapy in helping Type 2 diabetic&#xD;
      patients who have sleep disorders and mild depression to improve their sleep quality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Score on Pittsburgh Sleep Quality Index（PSQI）</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Score on Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>9 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin resistance measured as HOMA-IR</measure>
    <time_frame>9 months</time_frame>
    <description>HOMA-IR = (FINS×FPG) / 22.5</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>peer support and yoga music therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the group will receive peer support and yoga music therapy before bed.&#xD;
Patients in the group will received the group education courses and clinical medical therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the group will received the group education courses and clinical medical therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>peer support and yoga music therapy</intervention_name>
    <description>Patients in the intervention group will receive peer support and yoga music therapy before bed.</description>
    <arm_group_label>peer support and yoga music therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed type 2 diabetes patients (ICD9) according to the medical record and&#xD;
             patient's disease history&#xD;
&#xD;
          -  Diagnosis type 2 diabetes more than 6 months&#xD;
&#xD;
          -  40 Years to 84 Years old&#xD;
&#xD;
          -  Sleep-disordered patients (PSQI scores≥7)&#xD;
&#xD;
          -  Mild depression condition（14 ≥PHQ-9 scores≥ 5 分）&#xD;
&#xD;
          -  Have a stable T2DM condition，without any other diseases affect patients' sleep&#xD;
&#xD;
          -  Agree to participate in the study and have signed the Inform Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Terminal illnes&#xD;
&#xD;
          -  Hearing loss or severe visual disorder&#xD;
&#xD;
          -  Life expectancy is less than 12 months&#xD;
&#xD;
          -  Primary sleep apnoea syndrome&#xD;
&#xD;
          -  Serious physical pain that affect the quality of sleep&#xD;
&#xD;
          -  Using drugs that affect the quality of sleep&#xD;
&#xD;
          -  Individuals with histories of Alcohol or Drug Abuse&#xD;
&#xD;
          -  Patients with high risk for sleep apnea syndrome(STOP scores ≥3 )&#xD;
&#xD;
          -  Planned to receive selective surgery within 3months&#xD;
&#xD;
          -  Observed mental confusion suggesting dementia&#xD;
&#xD;
          -  Ongoing psychiatric care&#xD;
&#xD;
          -  Paralysis or residence in a long-term care facility&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liebin Zhao, MSM</last_name>
    <role>Study Chair</role>
    <affiliation>Center of Diabetes, Ruijin Hospital, Shanghai Jiao Tong University of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Jiao Tong University of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>December 2, 2014</last_update_submitted>
  <last_update_submitted_qc>December 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Guang Ning</investigator_full_name>
    <investigator_title>Shanghai Jiao Tong University School of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02198989
org study id: CCEMD-022
nct id: NCT02198989
lead sponsor: 
collaborator: 
has dmc: No
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
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Score on Pittsburgh Sleep Quality Index（PSQI）
time frame: 9 months
measure: Score on Patient Health Questionnaire (PHQ-9)
time frame: 9 month
measure: HbA1c
time frame: 9 months
measure: BMI
time frame: 9 months
measure: Insulin resistance measured as HOMA-IR
time frame: 9 months
description: HOMA-IR = (FINS×FPG) / 22.5
arm group label: peer support and yoga music therapy
arm group type: Experimental
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 group label: Control group
arm group type: No Intervention
description: Patients in the group will received the group education courses and clinical medical therapy.
intervention type: Behavioral
intervention name: peer support and yoga music therapy
description: Patients in the intervention group will receive peer support and yoga music therapy before bed.
arm group label: peer support and yoga music therapy
criteria: 
gender: All
minimum age: 40 Years
maximum age: 84 Years
healthy volunteers: No
last name: Liebin Zhao, MSM
role: Study Chair
affiliation: Center of Diabetes, Ruijin Hospital, Shanghai Jiao Tong University of Medicine
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Guang Ning
investigator title: Shanghai Jiao Tong University School of Medicine
mesh term: Sleep Wake Disorders
mesh term: Parasomnias