The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type… (NCT04831385) | Clinical Trial Compass
RecruitingNot Applicable
The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia
Hong Kong214 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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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;
✕
What they're measuring
1
The primary outcome measure will be changes in glycemic control, as measured by HbA1c, from baseline.