Efficacy of a Multicomponent Cognitive Intervention in Adults With Subjective Cognitive Decline and Mild Cognitive Impairments

NCT04023032 | Completed

• 1 other identifier: 201805012RINA
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with mild cognitive impairment (MCI) and subjective cognitive decline (SCD) have greater risk of developing dementia. Cognitive intervention is a topic of great interest in individuals with MCI and SCD for the purpose of preventing or delaying the occurrence of dementia. There are many different types of cognitive interventions, which aim to positively impact the cognitive functioning of an individual and have been classified as cognitive stimulation, cognitive training, and cognitive rehabilitation. However, most studies used neuropsychological cognitive measures for outcome evaluation. The impact of cognitive interventions on daily functional performance among individuals with MCI and SCD were rarely explored. In addition, cognitive training focusing on specific cognitive outcomes is suspected to have limited far transfer to everyday measures. Therefore, a multicomponent intervention which integrates several types of intervention is recommended to reach the maximum impact on daily function. The purposes of this study are to examine the effects of a multicomponent cognitive intervention on cognitive and daily functional outcomes in individuals with MCI and SCD, and to compare the effects between the two groups. In addition, the investigators will also investigate whether the demographic (e.g., age and educational level, etc.) and clinical variables (e.g., duration of cognitive complains, level of depression and baseline cognitive function, etc.) may affect the outcomes of cognitive intervention.

Conditions

Mild Cognitive Impairment; Subjective Cognitive Decline

Outcome Measures

Primary Outcomes (6)

• Change from Baseline the Brief University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA-Brief ) (Traditional Chinese Version) at 16 weeks, 32 weeks, and 48 weeks

  The UPSA-Brief, which consists of 2 subscales (communication and financial), is a useful performance-based functional outcome scale. It has adequate psychometric properties, predicts residential independence, is sensitive to change, and requires only 10-15 minutes to administer.

  baseline, 16th, 32nd and 48th week

• Change from Baseline the Activities of Daily Living Questionnaire at 16 weeks, 32 weeks, and 48 weeks

  The Activities of Daily Living Questionnaire (ADLQ) is an informant-based assessment of functional abilities in patients with probable Alzheimer disease and other forms of dementia. The ADLQ measures functioning in six areas: self-care, household care, employment and recreation, shopping and money, travel, and communication.

  baseline, 16th, 32nd and 48th week

• Change from Baseline the Contextual Memory Test (CMT) at 16 weeks, 32 weeks, and 48 weeks

  The CMT is used to objectively measure awareness of memory capacity, strategy use and recall in adults with memory dysfunction. It assess 3 areas of memory including: awareness of memory capacity, recall of line-drawn items, and strategy use.

  baseline, 16th, 32nd and 48th week

• Change from Baseline the Miami Prospective Memory Test (MPMT) at 16 weeks, 32 weeks, and 48 weeks

  The Miami Prospective Memory Test evaluates time-related and event-related prospective memory ability of older adults.

  baseline, 16th, 32nd and 48th week

• Change from Baseline the Everyday Memory Questionnaire (EMQ) at 16 weeks, 32 weeks, and 48 weeks

  The Everyday Memory Questionnaire (EMQ) was developed as a subjective measure of memory failure in everyday life.

  baseline, 16th, 32nd and 48th week

• Change from Baseline the Cognitive Failure Questionnaire (CFQ) at 16 weeks, 32 weeks, and 48 weeks

  The CFQ assesses the frequency with which people experienced cognitive failures in daily life.

  baseline, 16th, 32nd and 48th week

Secondary Outcomes (6)

• Change from Baseline the Word Sequence Learning Test at 16 weeks, 32 weeks, and 48 weeks

  baseline, 16th, 32nd and 48th week

• Change from Baseline the Wechsler Memory Scale-3rd ed. (WMS-III) Logical Memory (LM) subtest at 16 weeks, 32 weeks, and 48 weeks

  baseline, 16th, 32nd and 48th week

• Change from Baseline the Wechsler Memory Scale-3rd ed. (WMS-III) Family Pictures (FP) subtest at 16 weeks, 32 weeks, and 48 weeks

  baseline, 16th, 32nd and 48th week

• Change from Baseline the Color Trails Test at 16 weeks, 32 weeks, and 48 weeks

  baseline, 16th, 32nd and 48th week

• Change from Baseline the Geriatric Depression Scale-Short Form (GDS-S) at 16 weeks, 32 weeks, and 48 weeks

  baseline, 16th, 32nd and 48th week

Study Arms (1)

multicomponent cognitive intervention

EXPERIMENTAL

Behavioral: multicomponent cognitive intervention

Interventions

multicomponent cognitive intervention BEHAVIORAL

The intervention takes place in groups of 6-10 participants and is leaded by one occupational therapist. It includes 16 sessions, 90 minutes each. The first part of each session starts with a 15-minute review of previous homework or relaxation. The second part, which lasts 35 minutes, involves structured training with activity-sheets, board games, role-playing and computerized games. The third part, which lasts 30 minutes, is the lifestyle interventions. The instructor explains the generalization of the previous activities toward daily life, and introduces healthy lifestyles. Through group discussions, the therapist guides participants to develop solutions and strategies for their memory or cognition-related problems and application to daily life. The last 10 minutes are used to suggest homework.

multicomponent cognitive intervention

Eligibility Criteria

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

You may qualify if:

• over 50 years old
• years of education \> 6
• mild cognitive impairment or subjective cognitive decline diagnosed by physician
• the Barthel Index scored 100
• the Montreal Cognitive Assessment (MoCA) \> 18
• the UPSA-Brief \> 50

You may not qualify if:

• without concurrent major or significant psychiatric disorders
• severe physical diseases which might affect cognitive functions
• difficult to follow instructions due to visual or hearing impairments

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hui-Fen Mao

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: January 2, 2019
• Primary Completion: August 29, 2021
• Study Completion: August 29, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)