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Completed

NCT Number: NCT02462135

Protocol of Virtual Interactive Memory-Training Program

This study sought to investigate the changes in objective memory performance (including immediate recall and delayed recall), subjective memory complaints and degree of depression in older adults with mild cognitive impairment after Virtual interactive memory training (VIMT).

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Residential care facilities

Taipei, 22176, Taiwan

About this study

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 (Virtual interactive memory training, VIMT), or active control group (Passive information activities, PIA). Training sessions of the VIMT group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). The training of PIA group is the same as VIMT group. We constructed a rigorous VIMT program adhering to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. The investigators expect to determine the improvement in memory function and degree of depression of older adults with mild cognitive impairment after using the VIMT.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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, and cut-off score of 23/24 on the Montreal Cognitive Assessment (MoCA)
  • 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

Treatment and study plan

Virtual interactive memory training

Behavioral

Training sessions of the VIMT group are divided into initial training and booster training. Each training session is 45 minutes/day, 3 sessions/week, for 12 weeks for both initial training and booster training (36 sessions each). The training content of the four memory training include: (1) spatial encoding memory training task, (2) updating-spatial memory training task, (3) updating-visual memory training task, and (4) rehearsal-visuospatial memory training task.

Other names: Memory training

Passive information activities

Behavioral

The active control group (Passive information activities) only accepts the initial training phase, which training content of the two types to include: (1) listening to audio books, and (2) reading online newspaper.

Other names: Active control group

Primary outcomes

  1. Change in objective memory performance as measured by the Chinese version of the Wechsler Memory Scale-III (WMS-III).

    Time frame: Change from baseline in objective memory performance at Immediate post-test, 3 months, 6 months and one year after intervention.

Secondary outcomes

  1. Change in subjective memory complaints as measured by the Multifactorial Memory Questionnaire (MMQ).

    Time frame: Change from baseline in subjective memory complaints at Immediate post-test, 3 months, 6 months and one year after intervention.

Sponsors and collaborators

Lead sponsor

Ministry of Science and Technology, Taiwan

Other Gov

Registry information

Official study title

The Development and Evaluation of the Effectiveness of a Virtual Interactive Memory Training Program for Older Adults With Mild Cognitive Impairment: Protocol of a Randomized Controlled Study

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 3, 2015
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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