Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus
NCT ID: NCT06202742
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-03-08
2025-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cognitive behavioral therapy
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.
cognitive behavioral therapy for insomnia
Online meeting, weekly for 8 weeks, to deliver CBTI by psychologist/ psychiatrist
Health education
Health education group will attend online meeting, 1 hour weekly for 8 weeks.
Health education
Online meeting, weekly for 8 weeks, to deliver general health knowledge
Interventions
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cognitive behavioral therapy for insomnia
Online meeting, weekly for 8 weeks, to deliver CBTI by psychologist/ psychiatrist
Health education
Online meeting, weekly for 8 weeks, to deliver general health knowledge
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
30 Years
65 Years
ALL
Yes
Sponsors
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Mahidol University
OTHER
Responsible Party
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Principal Investigators
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Similan Kirisri
Role: PRINCIPAL_INVESTIGATOR
Ramathibodi Hospital
Locations
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Faculty of Medicine Ramathibodi Hospital Mahidol University
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MURA2023/873
Identifier Type: -
Identifier Source: org_study_id
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