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)

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

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NCT04831385


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