Subjective Cognitive DeclineNCT04330404
Effects of Cognitive Strategy Training on Daily Function in People With Subjective Cognitive Decline
A study testing Cognitive strategy training and group interactive game in people with Subjective Cognitive Decline, run by National Cheng Kung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Subjective Cognitive Decline
- What is being tested?
- Cognitive strategy training and group interactive game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Occupational Therapy, College of Medicine, National Cheng Kung University
Tainan, 701
About this study
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.
Read more
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.
- Conditions
- Subjective Cognitive Decline
- Being tested
- Cognitive strategy training, group interactive game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive strategy trainingBehavioural
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 gameBehavioural
The active control group will receive group interactive game, including table games and games using songs, balloons, newspapers and so on.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive strategy training | Experimental | 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. Receives: Behavioral: Cognitive strategy training |
| group interactive game | Active comparator | The active control group will receive group interactive game, including table games and games using songs, balloons, newspapers and so on. Receives: Behavioral: group interactive game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Canadian Occupational Performance Measure-Chinese version (COPM-C) at post-intervention, and 3-month follow-up.
Canadian Occupational Performance Measure-Chinese version (COPM-C) is a semi-structured interview questionnaire used to assess self-perceived problems in occupational performance areas.
Participants need to identify cognitive-related occupational performance problems, then score the importance from 1 to 10. The higher the score, the more important it is.
Participants also need to score their performance and satisfaction from 1 to 10 on the first five important issues. Higher scores mean a better outcome.
Measured: Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention. .
Secondary outcomes (3)
Change from Baseline General Self-Efficacy Scale (GSE) at post-intervention, and 3-month follow-up.
General Self-Efficacy Scale (GSE) is a self-reported questionnaire used to assess individual beliefs of how effective they are in facing stress and challenges. The scale scores range from 10 to 40, with higher scores indicating better self-efficacy.
Measured: Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.
Change from Baseline Contemplation ladder at post-intervention, and 3-month follow-up.
Contemplation ladder is an 11-point scale used to assess readiness and motivation for change before action. The scale score is between 0 and 10, with higher scores indicating greater motivation for change.
Measured: Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.
Change from Baseline COOP/WONCA (World Organization of Family Doctors) charts at post-intervention, and 3-month follow-up.
COOP/WONCA (World Organization of Family Doctors) is a self-reported chart used to assess health-related quality of life. The scale scores range from 6 to 30, with lower scores indicating better quality of life.
Measured: Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Nov 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group will receive the Cognitive strategy training. The active control group will receive group interactive game.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Chen Liu, National Cheng Kung University
- Investigators
- Shuchen Liu, Principal investigator, Department of Occupational Therapy, College of Medicine, National Cheng Kung University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330404
- Sponsor's protocol ID
- NCKU HREC-E-108-388-2
- Status last verified
- Mar 2020
- First submitted
- 22 Dec 2019
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Strategy Training on Daily Function in People With Subjective Cognitive Decline
- ClinicalTrials.gov ID
- NCT04330404
- Acronym / sponsor ID
- NCKU HREC-E-108-388-2
- Conditions
- Subjective Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The experimental group will receive the Cognitive strategy training. The active control group will receive group interactive game.
| Arm | Type | Receives |
|---|---|---|
| Cognitive strategy training | Experimental | Behavioral: Cognitive strategy trainingThe 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 interactive game | Active comparator | Behavioral: group interactive gameThe active control group will receive group interactive game, including table games and games using songs, balloons, newspapers and so on. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive strategy trainingThe Cognitive strategy training, including awareness enhancement, cognitive-related education, discussion of everyday cognitive difficulties, generation of cognitive strategies, cognitive strategy practice, and homework assignments | Behavioural | Cognitive strategy training |
| group interactive gameThe active control group will receive group interactive game, including table games and games using songs, balloons, newspapers and so on. | Behavioural | group interactive game |
Primary outcome
Change from Baseline Canadian Occupational Performance Measure-Chinese version (COPM-C) at post-intervention, and 3-month follow-up.
Time frame: Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention. .
Canadian Occupational Performance Measure-Chinese version (COPM-C) is a semi-structured interview questionnaire used to assess self-perceived problems in occupational performance areas. Participants need to identify cognitive-related occupational performance problems, then score the importance from 1 to 10. The higher the score, the more important it is. Participants also need to score their performance and satisfaction from 1 to 10 on the first five important issues. Higher scores mean a better outcome.
3 secondary outcomes
Change from Baseline General Self-Efficacy Scale (GSE) at post-intervention, and 3-month follow-up.
Time frame: Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.
Change from Baseline Contemplation ladder at post-intervention, and 3-month follow-up.
Time frame: Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.
Change from Baseline COOP/WONCA (World Organization of Family Doctors) charts at post-intervention, and 3-month follow-up.
Time frame: Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuchen Liu principal investigator
Department of Occupational Therapy, College of Medicine, National Cheng Kung University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive strategy training and group interactive game in people with Subjective Cognitive Decline, run by National Cheng Kung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Canadian Occupational Performance Measure-Chinese version (COPM-C) at post-intervention, and 3-month follow-up. (time frame: Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention. .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.