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

NCT04635085 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Empowerment-based Cognitive behavioral therapy for insomnia for MCI

Participants in the intervention group will participate in a 12-week empowerment-based CBT-I comprising face-to-face sessions supplemented with telephone follow-ups. In total, six face-to-face sessions (90 minutes/session) will be conducted in a small group format with 6-8 participants in a group.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Dr. Polly, Wai Chi LI · The School of Nursing, The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04635085 on ClinicalTrials.gov