Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus

Mahidol University

Status: Enrolling

Conditions: Insomnia; Type 2 Diabetes

Treatments: Behavioral: cognitive behavioral therapy for insomnia; Behavioral: Health education

Study type: Interventional

Funder types: Other

Identifiers

NCT06202742

MURA2023/873

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Cognitive behavioral therapy

Experimental group

Description:

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.

Treatment:

Behavioral: cognitive behavioral therapy for insomnia

Health education

Active Comparator group

Description:

Health education group will attend online meeting, 1 hour weekly for 8 weeks.

Treatment:

Behavioral: Health education