NCT06202742

Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus

Effects of Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: 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.

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 (8 weeks post intervention). Primary outcome will be subjective sleep quality as assessed by Pittsburgh Sleep Quality Index Secondary outcomes will be fasting glucose, hemoglobin A1C, insulin levels, high sensitivity c-reactive protein, objective sleep parameters from accelerometer, depressive symptoms, daytime sleepiness, quality of life, anxiety symptoms and stress symptoms.

Conditions

• Type 2 Diabetes
• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	cognitive behavioral therapy for insomnia	Online meeting, weekly for 8 weeks, to deliver CBTI by psychologist/ psychiatrist
BEHAVIORAL	Health education	Online meeting, weekly for 8 weeks, to deliver general health knowledge

Timeline

• Start date: 2024-03-08
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-01-11
• Last updated: 2024-03-15

Locations

1 site across 1 country: Thailand