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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Online meeting, weekly for 8 weeks, to deliver CBTI by psychologist/ psychiatrist
Online meeting, weekly for 8 weeks, to deliver general health knowledge
Faculty of Medicine Ramathibodi Hospital Mahidol University
Bangkok, Thailand
RECRUITINGSubjective Sleep Quality
Subjective Sleep Quality as assessed by Pittsburgh Sleep Quality Index
Time frame: 16 weeks
Metabolic parameters
Fasting glucose and insulin, hemoglobin A1C
Time frame: 8 weeks
High sensitivity c-reactive protein
serum sample for Hs-CRP
Time frame: 8 weeks
Patient reported outcomes
Questionnaires to assess depressive symptoms, stress, anxiety, daytime sleepiness, and quality of life
Time frame: 16 weeks
Objective sleep parameters
Sleep will be obtained using 1-week accelerometer recording
Time frame: 8 weeks
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