Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus

Last updated: March 13, 2024
Sponsor: Mahidol University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Insomnia

Treatment

cognitive behavioral therapy for insomnia

Health education

Clinical Study ID

NCT06202742
MURA2023/873
  • Ages 30-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Night shift work
  • Insulin therapy
  • Severe hypoglycemia who required hospitalization or emergency department visit in thepast 6 months
  • History of diabetic ketoacidosis in the past 6 months
  • Medically unstable conditions eg. renal replacement therapy, liver failure, heartfailure, 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

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: cognitive behavioral therapy for insomnia
Phase:
Study Start date:
March 08, 2024
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Faculty of Medicine Ramathibodi Hospital Mahidol University

    Bangkok, 10400
    Thailand

    Active - Recruiting

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