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Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus
RECRUITINGN/ASponsored by Mahidol University
Actively Recruiting
PhaseN/A
SponsorMahidol University
Started2024-03-08
Est. completion2025-06
Eligibility
Age30 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06202742
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.
Eligibility
Age: 30 Years – 65 YearsHealthy volunteers accepted
Inclusion Criteria: * 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 Criteria: * 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)
Conditions3
DiabetesInsomniaType 2 Diabetes
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Actively Recruiting
PhaseN/A
SponsorMahidol University
Started2024-03-08
Est. completion2025-06
Eligibility
Age30 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06202742