NCT02198989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

July 10, 2014

Last Update Submit

December 2, 2014

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

  • Score on Pittsburgh Sleep Quality Index（PSQI）

    9 months

  • Score on Patient Health Questionnaire (PHQ-9)

    9 month

  • HbA1c

    9 months

Secondary Outcomes (2)

  • BMI

    9 months

  • Insulin resistance measured as HOMA-IR

    9 months

Study Arms (2)

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.

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.

Interventions

peer support and yoga music therapyBEHAVIORAL

Patients in the intervention group will receive peer support and yoga music therapy before bed.

peer support and yoga music therapy

Eligibility Criteria

Age40 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed type 2 diabetes patients (ICD9) according to the medical record and patient's disease history
  • Diagnosis type 2 diabetes more than 6 months
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Jiao Tong University of Medicine

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Liebin Zhao, MSM

    Center of Diabetes, Ruijin Hospital, Shanghai Jiao Tong University of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Shanghai Jiao Tong University School of Medicine

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 24, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

CN(1)