Cognitive behavioral therapy for insomnia in people with type 2 diabetes
Effects of Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
This study tests if cognitive behavioral therapy for insomnia can help people with type 2 diabetes sleep better compared to just receiving health education.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT06202742 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of cognitive behavioral therapy for insomnia (CBTI) compared to health education in patients with type 2 diabetes who experience insomnia symptoms. Participants will be randomly assigned to receive either CBTI or health education for eight weeks, with outcomes measured at baseline, eight weeks, and sixteen weeks post-intervention. The primary outcome is subjective sleep quality, while secondary outcomes include various metabolic and psychological parameters. This approach aims to improve both sleep quality and diabetes management in affected individuals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 65 with type 2 diabetes and poor sleep quality.
Not a fit: Patients with type 1 diabetes, severe medical conditions, or untreated obstructive sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve sleep quality and metabolic control in patients with type 2 diabetes and insomnia.
How similar studies have performed: Other studies have shown promising results using cognitive behavioral therapy for insomnia in various populations, suggesting potential success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Bangkok
- Faculty of Medicine Ramathibodi Hospital Mahidol University — Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Similan Kirisri — Faculty of Medicine Ramathibodi Hospital, Mahidol University
- Study coordinator: Similan Kirisri
- Email: similankirisri@gmail.com
- Phone: 660805491645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.