The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia
Recruiting · NCT04831385 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
Cognitive Behavioural Therapy
What this trial is about
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.
Who can take part
Age range
60 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where it is running
1 location listed.
- 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