Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06202742
• Other study ID #: MURA2023/873
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Mahidol University
• Contact: Similan Kirisri
• Phone: 660805491645
• Email: similankirisri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insomnia
• Sleep Initiation and Maintenance Disorders
• Type 2 Diabetes

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Ramathibodi Hospital Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Sleep Quality	Subjective Sleep Quality as assessed by Pittsburgh Sleep Quality Index	16 weeks
Secondary	Metabolic parameters	Fasting glucose and insulin, hemoglobin A1C	8 weeks
Secondary	High sensitivity c-reactive protein	serum sample for Hs-CRP	8 weeks
Secondary	Patient reported outcomes	Questionnaires to assess depressive symptoms, stress, anxiety, daytime sleepiness, and quality of life	16 weeks
Secondary	Objective sleep parameters	Sleep will be obtained using 1-week accelerometer recording	8 weeks