|

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

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

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.