Protocol of Virtual Interactive Memory-Training Program

Ministry of Science and Technology, Taiwan

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Passive information activities; Behavioral: Virtual interactive memory training

Study type: Interventional

Funder types: Other

Identifiers

NCT02462135

201301045

Details and patient eligibility

About

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).

Full 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 (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.

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Participants must endorse at least two items from a list of frequent subjective memory complaints by patient and/or an informant
2. Objective memory impairment on neuropsychological tests of memory 1.5 SD or more below age/education norms
3. 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)
4. No impairment in personal activities of daily living (P-ADL) as determined by clinical interview with participant and family

Exclusion criteria

1. The clinical diagnosis of dementia was based on the DSM-IV-TR
2. Active in another cognitive or memory-related training in the past year
3. Comorbid medical conditions that would predispose them to imminent functional decline or cognitive impairment
4. A diagnosis of major neurological or psychiatric illness history and/or behavioral problems that would sufficiently impair performance to make participation impossible
5. Severe losses in vision, hearing, or communicative ability

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Virtual interactive memory training

Experimental group

Description:

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).

Treatment:

Behavioral: Virtual interactive memory training

Passive information activities

Active Comparator group

Description:

The training of active control group is the same as VIMT group (45 min/day, 3 days/week, for 12 weeks, for a total of 36 sessions). The active control group receives only the initial training.

Treatment:

Behavioral: Passive information activities