The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia

NCT04831385 | Recruiting

• 1 other identifier: CREC 2021.266
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a RCT aiming to use CBT-I as intervention, compared to usual care as control, to elucidate the effect of CBT-I on glycemic control, sleep quality, psychological outcomes, and cognitive function in Hong Kong Chinese older T2D comorbid with insomnia.

Conditions

Diabetes Mellitus, Type 2; Insomnia

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be changes in glycemic control, as measured by HbA1c, from baseline.

  12 months

Secondary Outcomes (5)

• Changes of other parameters of glycemic targets including FPG and glycemic variability and time in range (TIR) as measured by continuous glucose monitoring (CGM)

  12 months

• Change of sleep parameters measured by sleep diaries and actigraphy including SOL, WASO, SE and total sleep time (TST)

  12 months

• Changes of psychological parameters including distress, anxiety, mental well-being, self-care behavior and self-efficacy

  12 months

• Changes in cognitive function as measured by neuropsychological test battery and HK-MoCA

  12 months

• Changes of other parameters of metabolic control including blood pressure, insulin sensitivity and lipid profile

  12 months

Study Arms (2)

CBT-i

EXPERIMENTAL

Study subjects randomized to the intervention arm will receive a total of 6 sessions of CBT-I (2-hour group sessions weekly for 6 weeks, 6-8 participants per group).

Behavioral: Cognitive Behavioural Therapy

Control (Usual Care)

NO INTERVENTION

The study subjects randomized to the control group will receive usual care with continuation of follow-up by their healthcare providers. In order to have the same contact time as the study participants randomized to the active intervention group, the study subjects in the control group will receive a total of 6 sessions of seminars for delivery of general education about healthy diet, regular exercise, sleep hygiene, diabetes self-care, diabetes related complications (2-hour group sessions weekly for 6 weeks, 6-8 participants per group), with materials based on the usual education classes for diabetic patients from DMEC, without any element of CBT-I.

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

CBT is a first line therapy for insomnia

CBT-i

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥60 years;
• T2D with suboptimal glycemic control defined as HbA1c 7.1-10%;
• Chinese ethnicity;
• Comorbid with insomnia having ISI score \>10;
• Able and willing to give informed written consent

You may not qualify if:

• Cognitive impairment (HK-MoCA score of ≤22);
• Depression (GDS-15 score \>8) and other psychiatric disorders e.g. generalized anxiety disorder, restless leg syndrome, schizophrenia to be elucidated by history from research nurse and questionnaires;
• Benign prostatic hypertrophy by history and/or elevated PSA and any other chronic medical condition that is likely to affect sleep e.g. chronic pain;
• Concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep;
• Cerebrovascular accidents, vascular dementia, or any condition that are known to affect cognitive function;
• Shift workers;
• Haemoglobinopathies, renal failure, need of regular blood transfusion or any other conditions which will affect the validity of HbA1c in measurement of glycemia;
• Any condition, as judged by the investigators, as ineligible to participate in this study.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward 3M, Diabetes and Endocrine Research Centre, 3/F Day Treatment Block and Children Wards (Old Block), Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Alice Kong, MD

CONTACT

3505 2648; alicekong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: May 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)