NCT04635085

A Mixed Method Pilot Study for Patients With Mild Cognitive Impairment and Insomnia.

Completed NA Last updated 22 November 2023

What this trial tests

NA trial testing Empowerment-based Cognitive behavioral therapy for insomnia for MCI in Mild Cognitive Impairment in 60 participants. Completed in 30 April 2022.

Timeline

1 February 2021

Primary endpoint
30 April 2022

30 April 2022

Quick facts

Lead sponsor	The University of Hong Kong
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	60
Start date	1 February 2021
Primary completion	30 April 2022
Estimated completion	30 April 2022
Sites	1 location across Hong Kong

Drugs / interventions tested

• Empowerment-based Cognitive behavioral therapy for insomnia for MCI

Conditions studied

• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Insomnia — all drugs for Insomnia →

Sponsor

The University of Hong Kong

Who can join

50 and older, any sex, with Mild Cognitive Impairment or Insomnia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Dementia is irreversible, incurable and devastating. It is thus imperative to preserve cognition at the pre-dementia stage. Mild cognitive impairment (MCI) refers to the reversible intermediate clinical state between normal age-related cognitive decline and dementia. Because no pharmacological treatments have proved to be effective, risk factor modification remains the cornerstone in preventing progression from MCI to dementia. Insomnia is an emerging risk factor now being associated with cognitive decline, and it affects up to 59% of persons with MCI. Compelling evidence shows that sleep is vital for memory consolidation, and it mediates the deposition of amyloid-β and tau proteins in the brain. Despite these findings, minimal research has done to evaluate sleep-promoting interventions on the cognitive function of persons with MCI. Non-pharmacological interventions remain the treatment of choice for managing insomnia, particularly the older population. These interventions require individuals to actively participate in the treatment process. Yet, the cognitive impairment and neuropsychiatric symptoms in persons with MCI create challenges for them. An empowerment approach with interactive teaching strategies and experiential learning may be the best method of engaging people in the learning process and arousing their inherent capacity to maintain behavioral modifications. This study aims to examine the feasibility and preliminary effects of an empowerment-based cognitive behavioral therapy for insomnia (CBT-I) in persons with MCI and sleep problems. The researchers will compare the effects of this intervention by comparing with the standard care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. An empowerment-based cognitive behavioural therapy for persons with mild cognitive impairment and insomnia: Protocol for a mixed-method pilot study.
   Li PWC, Yu DSF, Wong CWY. · · 2021 · cited 1× · PMID 33438783 · DOI 10.1111/jan.14740