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Clinical Trials/NCT03379519
NCT03379519CompletedNot Applicable

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

Ministry of Science and Technology, Taiwan0 sites60 target enrollmentStarted: August 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Primary Endpoint
Change in attention as measured by the Digit Span Task (DS).

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Multi-domain Attention Training (MAT)

Experimental

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

Intervention: Multi-domain Attention Training (MAT) (Behavioral)

Passive information activities (PIA)

Active Comparator

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).

Intervention: Passive information activities (PIA) (Behavioral)

Outcomes

Primary Outcomes

Change in attention as measured by the Digit Span Task (DS).

Time Frame: Change from baseline in executive attention at Immediate post-test, 3 months, 6 months after intervention.

The primary outcome indicators is executive attention assessed by the Digit Span Task (DS).

Secondary Outcomes

  • Change in attention as measured by the Trail Making Test (TMT).(Change from baseline in spatial orienting attention at Immediate post-test, 3 months, 6 months after intervention.)

Investigators

Sponsor
Ministry of Science and Technology, Taiwan
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Yang, Hui-Ling

Ph.D. candidate

Ministry of Science and Technology, Taiwan

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