Status:
RECRUITING
Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus
Lead Sponsor:
Mahidol University
Conditions:
Type 2 Diabetes
Insomnia
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief Summary
This study will explore the effects of cognitive behavioral therapy for insomnia (CBTI) compare to health educations in patients with type 2 diabetes (T2DM) with insomnia symptoms.
Detailed Description
This study will recruit participants with T2DM with insomnia symptoms and randomize them to weekly CBTI or health education for 8 weeks. Outcomes will be measured at baseline and 8 week, and 16 weeks ...
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus age 30 to 65 years old
- Hemoglobin A1C ≥ 6.5 but ≤ 10 %
- Have poor sleep quality as assessed by Insomnia Severity Index ≥ 15
- Receive the same hypoglycemic treatments 3 months before the intervention
- If using sleep aid, the dose needs to be stable for 3 months prior to the enrollment
- Ability to use the electronic devices (computer, tablet) and assess the internet
- Willing to attend all of the 8 sessions activities
Exclusion
- Type 1 diabetes mellitus
- Night shift work
- Insulin therapy
- Severe hypoglycemia who required hospitalization or emergency department visit in the past 6 months
- History of diabetic ketoacidosis in the past 6 months
- Medically unstable conditions eg. renal replacement therapy, liver failure, heart failure, active cancer, epilepsy, unstable cerebrovascular disease
- Psychosis, uncontrolled depression
- Untreated obstructive sleep apnea or STOP-BANG ≥ 5
- Language/communication/hearing/sight disability
- Pregnancy or lactation
- Care giver of infant
- Harmful alcohol/smoking (≥15 standard-drink in men and ≥8 standard-drink in women)
Key Trial Info
Start Date :
March 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06202742
Start Date
March 8 2024
End Date
June 1 2025
Last Update
March 15 2024
Active Locations (1)
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1
Faculty of Medicine Ramathibodi Hospital Mahidol University
Bangkok, Thailand, 10400