Cognitive Behavioral Therapy for Insomnia in Type 2 Diabetes Mellitus

March 13, 2024 updated by: Mahidol University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chutintorn Sriphrapradang
  • Phone Number: 660819876945
  • Email: Chutins@gmail.com

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • Faculty of Medicine Ramathibodi Hospital Mahidol University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: cognitive behavioral therapy for insomnia
Online meeting, weekly for 8 weeks, to deliver CBTI by psychologist/ psychiatrist
Active Comparator: Health education
Health education group will attend online meeting, 1 hour weekly for 8 weeks.
Behavioral: Health education
Online meeting, weekly for 8 weeks, to deliver general health knowledge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Sleep Quality
Time Frame: 16 weeks
Subjective Sleep Quality as assessed by Pittsburgh Sleep Quality Index
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic parameters
Time Frame: 8 weeks
Fasting glucose and insulin, hemoglobin A1C
8 weeks
High sensitivity c-reactive protein
Time Frame: 8 weeks
serum sample for Hs-CRP
8 weeks
Patient reported outcomes
Time Frame: 16 weeks
Questionnaires to assess depressive symptoms, stress, anxiety, daytime sleepiness, and quality of life
16 weeks
Objective sleep parameters
Time Frame: 8 weeks
Sleep will be obtained using 1-week accelerometer recording
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Similan Kirisri, Faculty of Medicine Ramathibodi Hospital, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

January 1, 2024

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MURA2023/873

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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