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CompletedNCT03379519Updated Feb 20, 2020

Protocol of Multi-domain Attention Training

An interventional study of Multi-domain Attention Training (MAT) and Passive information activities (PIA) in Mild Cognitive Impairment, sponsored by Ministry of Science and Technology, Taiwan. Completed. Per ClinicalTrials.gov, last updated 2020-02-20.

Sponsored by Ministry of Science and Technology, Taiwan · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Mild Cognitive Impairment
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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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)

  • 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)

Interventions

  • BehavioralMulti-domain Attention Training (MAT)

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

    Also known as: Attention training

  • BehavioralPassive information activities (PIA)

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

    Also known as: Active control group

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What researchers measure

Primary outcomes

  1. 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).

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

Secondary outcomes

  1. 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.

    Time frame: Change from baseline in spatial orienting attention at Immediate post-test, 3 months, 6 months after intervention.

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Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03379519
Lead sponsor
Ministry of Science and Technology, Taiwan
Responsible party
Yang, Hui-Ling (Ph.D. candidate, Ministry of Science and Technology, Taiwan) — Principal investigator
First posted
Dec 20, 2017
Start date
Aug 1, 2016
Primary completion
May 31, 2019
Completion
Dec 31, 2019
Last update
Feb 20, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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