Clinical trial NCT04330404: Effects of Cognitive Strategy Training on Daily Function in People With Subjective Cognitive Decline
Official title: Effects of Cognitive Strategy Training on Daily Function in People With Subjective Cognitive Decline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subjective Cognitive Decline
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group will receive the Cognitive strategy training. The active control group will receive group interactive game.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Canadian Occupational Performance Measure-Chinese version (COPM-C) at post-intervention, and 3-month follow-up.
timeFrame: Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention. .
Secondary outcomes:
measure: Change from Baseline General Self-Efficacy Scale (GSE) at post-intervention, and 3-month follow-up.
timeFrame: Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.
measure: Change from Baseline Contemplation ladder at post-intervention, and 3-month follow-up.
timeFrame: Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.
measure: Change from Baseline COOP/WONCA (World Organization of Family Doctors) charts at post-intervention, and 3-month follow-up.
timeFrame: Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Department of Occupational Therapy, College of Medicine, National Cheng Kung University
Study officials:
affiliation: Department of Occupational Therapy, College of Medicine, National Cheng Kung University, Taiwan
name: Shuchen Liu
role: PRINCIPAL_INVESTIGATOR
References: