Effects of Cognitive Strategy Training on Daily Function in People With Subjective Cognitive Decline

NCT ID: NCT04330404

Last Updated: 2020-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-12-31

Brief Summary

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Subjective cognitive decline (SCD) is the transitional state between normal aging and mild cognitive impairment. SCD is defined as having self-perceived declines in any cognitive domain over time; having normal performance on cognitive testing; no dementia or depression. Cognitive difficulties can lead to a decline on daily function and quality of life. Early intervention can prevent SCD from developing into dementia.

Cognitive strategy training (CST) aims to generate individualized strategies to solve cognitive problems, which can be effective to improve daily functions and performances. However, there is limited clinical research aimed at improving daily functions for SCD. Most non-pharmacological studies have conducted objective cognitive training, which may not enhance daily performance. Previous studies also seldom examine the effectiveness of the intervention to improve daily function, quality of life, self-efficacy and motivation.

This study adopts a quasi-experimental design. The investigators will recruit 80 community-dwelling people with SCD who are aged 55 and older. There will be 40 participants in each group. The experimental group will receive the CST. The active control group will receive group interactive game. Both groups will have 8 sessions for one hour per week for a total of 8 weeks. Outcome measures include daily function, self-efficacy, motivation for change, and quality of life. Assessments will be performed at baseline, post-intervention, and 3-month follow-up. The demographic data of the two groups will be compared using the independent sample t-test and chi-square test. Changes on outcomes between the two groups will be analyzed by two-way ANOVA. This study was approved by the Human Research Ethics Committee at National Cheng Kung University. All participants provided written informed consent before testing.

This study aims to (1) examine the feasibility of the CST in community-dwelling people with SCD; (2) explore the efficacy of the CST on daily function, self-efficacy, motivation for change, and quality of life.

Detailed Description

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Conditions

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Subjective Cognitive Decline

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The experimental group will receive the Cognitive strategy training. The active control group will receive group interactive game.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
For the interventionist, it is important to build relationships with participants through baseline interviews. The pre-test will be conducted by the interventionist. Assessors at post-intervention, and 3-month follow-up will be blind to the group allocation.

Study Groups

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Cognitive strategy training

The experimental group will receive the Cognitive strategy training (CST), which includes awareness enhancement, cognitive-related education, discussion of everyday cognitive difficulties, generation of cognitive strategies, cognitive strategy practice, and homework assignments.

Group Type EXPERIMENTAL

Cognitive strategy training

Intervention Type BEHAVIORAL

The Cognitive strategy training, including awareness enhancement, cognitive-related education, discussion of everyday cognitive difficulties, generation of cognitive strategies, cognitive strategy practice, and homework assignments

group interactive game

The active control group will receive group interactive game, including table games and games using songs, balloons, newspapers and so on.

Group Type ACTIVE_COMPARATOR

group interactive game

Intervention Type BEHAVIORAL

The active control group will receive group interactive game, including table games and games using songs, balloons, newspapers and so on.

Interventions

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Cognitive strategy training

The Cognitive strategy training, including awareness enhancement, cognitive-related education, discussion of everyday cognitive difficulties, generation of cognitive strategies, cognitive strategy practice, and homework assignments

Intervention Type BEHAVIORAL

group interactive game

The active control group will receive group interactive game, including table games and games using songs, balloons, newspapers and so on.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* aged 55 and above
* live in community
* self-perceived decline in cognition compared to five years ago
* subjective cognitive decline, Cognitive Failure Questionnaire (CFQ) score above zero.

Exclusion Criteria

* objective cognitive impairment, Taiwanese version of the Montreal Cognitive Assessment (MoCA-T) scores below 24
* any medical, neurological or psychiatric disorders, Brief Symptom Rating Scale (BSRS-5) scores 10 or more
* severe visual, auditory, verbal or physical impairments interfere with communication, command compliance, and strategy execution
* participate in other research related to cognitive strategy at the same time.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng Kung University

OTHER

Sponsor Role lead

Responsible Party

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Shu-Chen Liu

Graduate student, Department of Occupational Therapy, College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuchen Liu

Role: PRINCIPAL_INVESTIGATOR

Department of Occupational Therapy, College of Medicine, National Cheng Kung University, Taiwan

Locations

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Department of Occupational Therapy, College of Medicine, National Cheng Kung University

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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NCKU HREC-E-108-388-2

Identifier Type: -

Identifier Source: org_study_id

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