Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes; Insomnia
• Interventions: Behavioral: cognitive behavioral therapy for insomnia; Behavioral: Health education

• Registration Number: NCT06202742
• Lead Sponsor: Mahidol University

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 (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.

Study Timeline

• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2024-01-01
• Study First Posted: 2024-01-11
• Status Verified: 2024-03
• Study Start: 2024-03-08
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive behavioral therapy	cognitive behavioral therapy for insomnia	Cognitive behavioral therapy for insomnia (CBTI) is non-medical treatment to improve insomnia. CBTI group will attend online meeting, 1 hour weekly for 8 weeks.
Health education	Health education	Health education group will attend online meeting, 1 hour weekly for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Subjective Sleep Quality	16 weeks	Subjective Sleep Quality as assessed by Pittsburgh Sleep Quality Index

Secondary Outcome Measures

Name	Time	Method
High sensitivity c-reactive protein	8 weeks	serum sample for Hs-CRP
Metabolic parameters	8 weeks	Fasting glucose and insulin, hemoglobin A1C
Patient reported outcomes	16 weeks	Questionnaires to assess depressive symptoms, stress, anxiety, daytime sleepiness, and quality of life
Objective sleep parameters	8 weeks	Sleep will be obtained using 1-week accelerometer recording

Trial Locations

Locations (1)

Faculty of Medicine Ramathibodi Hospital Mahidol University; 🇹🇭 Bangkok, Thailand