NCT06202742

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 8, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.2 years

First QC Date

December 12, 2023

Last Update Submit

March 13, 2024

Conditions

Type 2 DiabetesInsomnia

Keywords

cognitive behavioral therapy for insomnia

Outcome Measures

Primary Outcomes (1)

  • Subjective Sleep Quality

    Subjective Sleep Quality as assessed by Pittsburgh Sleep Quality Index

    16 weeks

Secondary Outcomes (4)

  • Metabolic parameters

    8 weeks

  • High sensitivity c-reactive protein

    8 weeks

  • Patient reported outcomes

    16 weeks

  • Objective sleep parameters

    8 weeks

Study Arms (2)

Cognitive behavioral therapy

EXPERIMENTAL

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

Health education

ACTIVE COMPARATOR

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

Behavioral: Health education

Interventions

cognitive behavioral therapy for insomniaBEHAVIORAL

Online meeting, weekly for 8 weeks, to deliver CBTI by psychologist/ psychiatrist

Cognitive behavioral therapy
Health educationBEHAVIORAL

Online meeting, weekly for 8 weeks, to deliver general health knowledge

Health education

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital Mahidol University

Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Similan Kirisri

    Ramathibodi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Similan Kirisri

CONTACT

660805491645similankirisri@gmail.com

Chutintorn Sriphrapradang

CONTACT

660819876945Chutins@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2023

First Posted

January 11, 2024

Study Start

March 8, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)