The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Hong Kong Special Administrative Region
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
RECRUITING
Hong Kong
Contact Information
Primary
Alice Kong, MD
alicekong@cuhk.edu.hk
3505 2648
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 214
Treatments
Experimental: CBT-i
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).
No_intervention: Control (Usual Care)
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.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong