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Protocol of Multi-domain Attention Training

NCT03379519 — Not applicable, Completed, 60 participants, Ministry of Science and Technology, Taiwan

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

RegistryNCT03379519
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, prevention
Enrollment60 (Estimated)
SponsorMinistry of Science and Technology, Taiwan (Other gov)
ConditionsMild Cognitive Impairment
InterventionsMulti-domain Attention Training (MAT), Passive information activities (PIA) (Behavioral)
Datesstart 2016-08-01, primary completion 2019-05-31, completion 2019-12-31, first posted 2017-12-20, last updated 2020-02-20

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-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Multi-domain Attention Training (MAT)ExperimentalBehavioral: Multi-domain Attention Training (MAT)Training sessions of the MAT group is 45 minutes/day, 3 sessions/week, for 12 weeks (36 sessions).
Passive information activities (PIA)Active comparatorBehavioral: 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).
  • Multi-domain Attention Training (MAT) (Behavioral), also known as Attention training: The training content emphasis three concept of attention include: intensity of attention, executive attention, and spatial orienting attention.
  • Passive information activities (PIA) (Behavioral), also known as Active control group: The active control group (Passive information activities) training content included reading online e-books and playing online games.

+Outcome measures

Primary outcomes

  • Change in attention as measured by the Digit Span Task (DS). [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.]: The secondary outcome indicator is spatial orienting attention evaluated by the Trail Making Test.

+Eligibility

Sex: All

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

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