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

NCT04635085 | Completed

• 1 other identifier: HKWC-2020-0029
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Mild Cognitive Impairment; Insomnia

Keywords

mild cognitive impairment; Empowerment; insomnia; sleep; cognitive function

Outcome Measures

Primary Outcomes (9)

• Changes from Baseline in Sleep on the 19 item The Pittsburgh Sleep Quality (PSQI) Index at the 12th week and 3 months

  The Chinese PSQI is a validated, self-reported instrument for assessing sleep disturbance over the month. A 3-point Likert scale is used to each item (0=no difficulty; to 3 =severe difficulty). Possible total score ranging from 0-21. MCI persons with global score\>5 will be eligible for inclusion.

  Change from Baseline Chinese PSQI at the 12th week (after the intervention) and 3 months (follow up)]

• Changes from Baseline in Insomnia Severity on the 7-item The Chinese version of the Insomnia Severity Index (ISI-C)at the 12th week and 3 months

  The ISI-C is a validated, self-reported instrument for assessing the perceived insomnia severity, consequences of insomnia and the degree of distress related to insomnia. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), Possible a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

  Change from Baseline ISI-C at the 12th week (after the intervention) and 3 months (follow up)]

• An Actiwatch, which contains an accelerometer (during sleep for a consecutive seven-day period)

  to record the frequency of body movement, will be used to objectively assess sleep patterns automatically.

  Change from Baseline the frequency of body movement at the 12th week (after the intervention) and 3 months (follow up)]

• An Actiwatch, which contains an accelerometer (during sleep for a consecutive seven-day period)

  to record the intensity of body movement, will be used to objectively assess sleep patterns automatically.

  Change from Baseline the intensity of body movement at the 12th week (after the intervention) and 3 months (follow up)]

• An Actiwatch, which contains an accelerometer (during sleep for a consecutive seven-day period)

  To record the sleep parameters include total sleep time (TST), sleep latency (SL), wake after sleep onset (WASO) and the ratio of total sleep time (TST) to sleep efficiency (SE) of sleep, will be used to objectively assess sleep patterns automatically.

  Change from Baseline sleep parameters at the 12th week (after the intervention) and 3 months (follow up)]

• Changes from the Cantonese version of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)

  The ADAS-Cog is a validated instrument for assessing language, memory in order to detect the subtle cognitive changes. The standard ADAS-cog includes the following 11 items, with a possible Total scoring range of 0 - 70. The ADAS score is based on the number of errors made in each item. A score of 70 represents the most severe impairment and 0 represents the least impairment.

  Change from Baseline ADAS-Cog at the 12th week (after the intervention) and 3 months (follow up)]

• Changes from the Hong Kong List Learning Test (HKLLT)

  The HKLLT is a validated instrument for assessing complex attention, executive function and task switching. Participants were required to learn a list of 16 Chinese words through three learning trials. After 10 and 30 min delay, they were asked to recall as many words as possible. The total number of recalled words after a delay was used to reflect verbal memory ability. A low score on Trial 1, with normal performance on Trial 3 and total learning, is considered to reflect problems in auditory attention spam, but intact learning ability. Poor scores on all three learning trials provide evidence for acquisition problems in learning and memory. The T-score range from \<20 to \>/= 65. The score of \>=65 represents superior and \<20 represents the severely impaired.

  Change from Baseline HKLLT at the 12th week (after the intervention) and 3 months (follow up)]

• the Color Trail Test (CCT)

  CCT is a validated instrument for assessing complex attention, executive function and task switching. Time taken to complete each part of the CTT is recorded in seconds and is compared to normative data. Qualitative aspects of the performance that may be indicative of brain dysfunction (e.g. near misses, prompts required, sequencing errors for color and number) are also recorded. The CTT manual reports that it takes 3-8 minutes to complete the CTT. A task is discontinued if the client takes longer than 240 seconds to complete it. Performance time \<60 seconds on the CTT was found to predict passing the on-road evaluation, whereas \>60 seconds was predictive of failing

  Change from Baseline the CCT at the 12th week (after the intervention) and 3 months (follow up)]

• The Chinese Hong Kong version of the Short Form Health Survey (SF-12)

  SF-12 is a validated instrument for assessing the general health of people, both physical and mental well-being. A mental component score and a physical component score are reported as Z-scores (different compared to the population average, 12 are both 50 points). The standard deviation is 10 points, so each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.

  Change from Baseline SF-12 at the 12th week (after the intervention) and 3 months (follow up)]

Study Arms (2)

Empowerment-based Cognitive behavioral therapy for insomnia for MCI (intervention)

EXPERIMENTAL

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.

Behavioral: Empowerment-based Cognitive behavioral therapy for insomnia for MCI

Social Activities provided by the community centers (active control)

NO INTERVENTION

The control group will not receive any structured cognitive training or sleep promoting interventions during the study period. The participants in the control group will continue to participate in the social activities offered by the elderly community centers. They have access to the newspapers, board games and computer facility in the centers. Upon completion of collecting all evaluation data for both groups at the three different time points, the empowerment-based CBT-I will be offered to participants in the control group.

Interventions

Empowerment-based Cognitive behavioral therapy for insomnia for MCI BEHAVIORAL

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.

Empowerment-based Cognitive behavioral therapy for insomnia for MCI (intervention)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged \>=50 years
• living in the community
• Independence in daily living as evaluated through the clinical interview
• Presence of cognitive complaints, defined as \>= 3 complaints on the Memory Inventory for Chinese
• Abnormal objective cognitive performance defined as \<-1.5 standard deviations from age
• Education-matched normal persons on the Montreal Cognitive Assessment Hong Kong Version (HK-MoCA)
• Persons with poor sleep quality that can be assessed by the Pittsburgh Sleep Quality Index, with a global PSQI score of \>5

You may not qualify if:

• Persons with confirmed dementia
• Persons with known psychiatric conditions
• Persons with impaired communication
• Persons with sleep disorders with an organic cause (e.g., sleep apnea, or restless legs syndrome) or due to a medical problem (e.g., pain)
• Persons with the use of hypnotics and other medications known to affect sleep (e.g., steroids, anxiolytics)

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Polly Wai Chi

Hong Kong, Please Select, 00000, Hong Kong

Location

Related Publications (1)

• Li PWC, Yu DSF, Wong CWY. An empowerment-based cognitive behavioural therapy for persons with mild cognitive impairment and insomnia: Protocol for a mixed-method pilot study. J Adv Nurs. 2021 Apr;77(4):2054-2063. doi: 10.1111/jan.14740. Epub 2021 Jan 13.

  PMID: 33438783 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Sleep Initiation and Maintenance Disorders; Empowerment

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Social Behavior; Behavior

Study Officials

• Dr. Polly, Wai Chi LI

  The School of Nursing, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 18, 2020
• Study Start: February 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)