RecruitingNot ApplicableNCT04831385
The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia
Sponsor
Chinese University of Hong Kong
Enrollment
214 participants
Start Date
May 1, 2022
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 60 Years
Inclusion Criteria5
- 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 Criteria8
- 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.
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Interventions
BEHAVIORALCognitive Behavioural Therapy
CBT is a first line therapy for insomnia
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04831385
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