Protocol of Multi-domain Attention Training

The Development and Evaluation of Multi-domain Attention Training for Older Adults With Mild Cognitive Impairment

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

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Multi-domain Attention Training (MAT); Behavioral: Passive information activities (PIA)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-domain Attention Training (MAT); Training sessions of the MAT group is 45 minutes/day, 3 sessions/week, for 12 weeks (36 sessions).	Behavioral: Multi-domain Attention Training (MAT); The training content emphasis three concept of attention include: intensity of attention, executive attention, and spatial orienting attention.; Other Names: Attention training
Active Comparator: 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).	Behavioral: Passive information activities (PIA); The active control group (Passive information activities) training content included reading online e-books and playing online games.; Other Names: Active control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in attention as measured by the Digit Span Task (DS).	The primary outcome indicators is executive attention assessed by the Digit Span Task (DS).	Change from baseline in executive attention at Immediate post-test, 3 months, 6 months after intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in attention as measured by the Trail Making Test (TMT).	The secondary outcome indicator is spatial orienting attention evaluated by the Trail Making Test.	Change from baseline in spatial orienting attention at Immediate post-test, 3 months, 6 months after intervention.

Collaborators and Investigators

• Sponsor: Ministry of Science and Technology, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: December 10, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: N201602069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No