Protocol of Multi-domain Attention Training

NCT ID: NCT03379519

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2019-12-31

Brief Summary

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This study sought to investigate the changes in attention in older adults with mild cognitive impairment after Multi-domain Attention Training .

Detailed Description

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This double-blind randomized controlled study has a 2-arm parallel group design. All subjects will be randomized by the block randomization, into intervention group (Multi-domain Attention Training, MAT), or active control group (Passive information activities, PIA). Training sessions of the MAT group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). The training of PIA group is the same as MAT group. The investigators constructed a rigorous MAT program adhering to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. The investigators expect to determine the improvement in attention function of older adults with mild cognitive impairment after using the MAT program.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Multi-domain Attention Training (MAT)

Training sessions of the MAT group is 45 minutes/day, 3 sessions/week, for 12 weeks (36 sessions).

Group Type EXPERIMENTAL

Multi-domain Attention Training (MAT)

Intervention Type BEHAVIORAL

The training content emphasis three concept of attention include: intensity of attention, executive attention, and spatial orienting attention.

Passive information activities (PIA)

The training sessions of PIA is the same as MAT group (45 min/day, 3 days/week, for 12 weeks, for a total of 36 sessions).

Group Type ACTIVE_COMPARATOR

Passive information activities (PIA)

Intervention Type BEHAVIORAL

The active control group (Passive information activities) training content included reading online e-books and playing online games.

Interventions

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Multi-domain Attention Training (MAT)

The training content emphasis three concept of attention include: intensity of attention, executive attention, and spatial orienting attention.

Intervention Type BEHAVIORAL

Passive information activities (PIA)

The active control group (Passive information activities) training content included reading online e-books and playing online games.

Intervention Type BEHAVIORAL

Other Intervention Names

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Attention training Active control group

Eligibility Criteria

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Inclusion Criteria

* Participants must endorse at least two items from a list of frequent subjective memory complaints by patient and/or an informant
* Objective memory impairment on neuropsychological tests of memory 1.5 SD or more below age/education norms
* Clinical neurologic examination by the Mini-Mental State Examination (MMSE) score of 24 or higher
* No impairment in personal activities of daily living (P-ADL) as determined by clinical interview with participant and family

Exclusion Criteria

* The clinical diagnosis of dementia was based on the DSM-IV-TR
* Active in another cognitive or memory-related training in the past year
* Comorbid medical conditions that would predispose them to imminent functional decline or cognitive impairment
* A diagnosis of major neurological or psychiatric illness history and/or behavioral problems that would sufficiently impair performance to make participation impossible
* Severe losses in vision, hearing, or communicative ability
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yang, Hui-Ling

Ph.D. candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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N201602069

Identifier Type: -

Identifier Source: org_study_id

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