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Cognitive TrainingNCT06110858

Efficacy of Tinkering Activities in Individuals With Subjective Cognitive Decline

A study testing Tinkering Activities in people with Cognitive Training and Subjective Cognitive Decline, run by National Taiwan University Hospital at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Given that preventing and delaying the onset of dementia is a crucial public health policy issues worldwide, it is essential to develop effective interventions and implement early interventions before the onset of dementia. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Tinkering Activities
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesTaiwan
Study dates
13 Nov 2023to 29 Aug 2024
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥50 years
  • Can communicate in Mandarin and is literate in Chinese
  • No impairment in basic activities of daily living(BADL) or Barthel Index score of 100
  • Score >23 on the Taiwanese version of the Montreal Cognitive Assessment(MoCA-T)
  • Willing and able to participate fully in the intervention
  • Individuals with Subjective Cognitive Decline, screened from the communities:
  • Experience subjective cognitive difficulties: answered "yes" to any questions in part I of the Subjective Cognitive Decline Scale(SCDS).
  • Display normal performance in the Color Trails Test and Word Lists Test of the Wechsler Memory Scale-3rd Edition(after adjustment of age, gender and education, scoring on average above -1.5 standard deviations)

Who cannot join

  • Diagnosed with Mild Cognitive Impairment(MCI) or Dementia
  • Cognitive changes due to psychiatric or neurological disorders, substance abuse, and those with unstable conditions and symptomatic disturbances, or a score of ≥ 29 on the Beck Depression Inventory II (BDI-II)
  • Unable to participate due to physical illnesses
  • Severe impairment in visual and auditory abilities
  • Participated in other cognitive training while engaged in this study

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • National Taiwan University

    Taipei

  • School of Occupational Therapy, College of Medicine, National Taiwan University

    Taipei

Other trials in Taiwan

About this study

Official title: The Efficacy of Tinkering Activity Based Cognitive Intervention to Improve Executive Function in Individuals With Subjective Cognitive Decline：A Pilot Study

Given that preventing and delaying the onset of dementia is a crucial public health policy issues worldwide, it is essential to develop effective interventions and implement early interventions before the onset of dementia. Subjective Cognitive Decline (SCD) is considered the earliest manifestation of dementia and individuals with SCD may have a higher risk for future cognitive decline and dementia. Despite performing normally on objective cognitive tests, individuals with SCD have been found to exhibit worse performance on some cognitive domains, including executive functions, compared to those without SCD. Executive Functions (EFs) refer to a set of cognitive processes that include working memory, inhibition, cognitive flexibility, planning, problem solving and reasoning, enabling individuals to achieve goals by controlling and regulating thoughts and behaviors. EFs are important for our daily functioning and their decline can negatively impact an individual's quality of life. However, to our knowledge, there is limited research on maintaining or improving EFs in individuals with SCD. Tinkering Activity (TA) is a hands-on cognitive activity that emphasizes process of problem-solving, active engagement and open-ended exploration, which challenges EFs. In addition, previous research has shown the benefits of TA for community-dwelling older adults.

Therefore, the goal of this clinical tri is to examine the efficacy of TA based cognitive intervention in enhancing EFs in individuals with SCD. This study will be a one-group pretest-posttest design. Twelve to fifteen individuals with SCD will be recruited from the communities. All participants will receive 12 intervention sessions, each lasting 2 hours, with two sessions per week for 6 weeks. All participants will be assessed before and after the intervention.

Being tested
Tinkering Activities
Keywords
Subjective Cognitive Decline, Cognitive Intervention, Executive Function, Problem Solving, Cognitive Flexibility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tinkering ActivitiesBehavioural

    Tinkering activities encompass elements of science, art and technology. They emphasize that learning is not simply about teachers imparting knowledge to students, but rather about students actively constructing knowledge themselves. Tinkering activities are characterized by three key elements: active engagement, open-ended exploration and problem-solving. In such activities, participants are provided with products without telling the steps. They are then encouraged to attempt creating it on their own. During this hands-on learning process, participants need to flexibly change their mindset, think outside the box and tackle emerging problems, which challenge their executive functions.

Study groups in NCT06110858
Study groupRoleWhat they receive
Tinkering ActivitiesExperimentalNot described
Receives: Behavioral: Tinkering Activities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of Tower of Hanoi task(TOH)

    Scoring takes into account the number of movements, completion times, and the number of violations. Fewer movements, shorter completion times, and fewer violations indicate better planning and problem-solving.

    Measured: Week 0, Week 6

  2. Changes of Task Switching Paradigm(TS)

    Scoring takes into account reaction time and accuracy. Faster reaction times and higher accuracy indicate better cognitive flexibility.

    Measured: Week 0, Week 6

  3. Changes of Colour Trails Test-2(CTT-2)

    Scoring takes into account times, colour errors, number errors, near-misses and prompts. Fewer times, colours errors, number errors, near-misses and prompts indicate better cognitive flexibility.

    Measured: Week 0, Week 6

Secondary outcomes (12)

  1. Changes of Guilford's Alternative Uses Task(GAU)

    Scoring includes criteria such as originality, fluency, flexibility and elaboration. A higher score indicates better creativity and divergent thinking.

    Measured: Week 0, Week 6

  2. Changes of Remote Associates Test(RAT)

    Scoring ranges from 0 to 30. A higher score indicates better remote associate ability.

    Measured: Week 0, Week 6

  3. Changes of the Brief University of California San Diego Performance-Based Skills Assessment-Traditional Chinese Version(UPSA-B)

    Scoring ranges from 0 to100. A higher score indicates better performance in instrumental activities of daily living.

    Measured: Week 0, Week 6

  4. Changes of Computerized Everyday Cognitive Function Assessment(CECFA)

    Scoring takes into account both correct rate and time. A higher score indicates better performance in instrumental activities of daily living.

    Measured: Week 0, Week 6

  5. Changes of the Taiwanese version of the Montreal Cognitive Assessment(MoCA-T)

    Scoring ranges from 0 to 30. A higher score indicates better objective cognitive function.

    Measured: Week 0, Week 6

  6. Changes of Subjective Cognitive Decline Scale(SCDS)

    Scoring ranges from 14 to 70. A higher score indicates individuals perceive more subjective cognitive difficulties.

    Measured: Week 0, Week 6

  7. Changes of Word Lists Test(WLT) in Wechsler Memory Scale-3rd Edition(WMS-III)

    Scoring includes part I(WLT-I) and part II(WLT-II). WLT-II is administered 25-35 minutes after WLT-I. A higher score indicates better verbal short term and long-term memory.

    Measured: Week 0, Week 6

  8. Changes of Family Pictures(FP) in Wechsler Memory Scale-3rd Edition(WMS-III)

    Scoring includes part I(FP-I) and part II(FP-II). FP-II is administered 25-35 minutes after WLT-I. A higher score indicates better visual short term and long-term memory.

    Measured: Week 0, Week 6

  9. Changes of Colour Trails Test-1(CTT-1)

    Scoring takes into account times, errors, near-misses and prompts. Fewer times, errors, near-misses and prompts indicate better attention.

    Measured: Week 0, Week 6

  10. Changes of Beck Depression Inventory II(BDI-II)

    Scoring ranges from 0 to 63. A higher score indicates individuals perceive more severe depressive symptoms.

    Measured: Week 0, Week 6

  11. Changes of Beck Anxiety Inventory(BAI)

    Scoring ranges from 0 to 63. A higher score indicates individuals perceive more severe anxiety symptoms.

    Measured: Week 0, Week 6

  12. Changes of General Self-Efficacy Scale(GSE)

    Scoring ranges from 10 to 40. A higher score indicates better self-efficacy.

    Measured: Week 0, Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2023
  2. Study start13 Nov 2023
  3. Primary completion29 Aug 2024
  4. Study completion29 Aug 2024

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06110858
Sponsor's protocol ID
202310004RIND
Status last verified
Oct 2023
First submitted
26 Oct 2023
Last updated
20 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tinkering Activities in people with Cognitive Training and Subjective Cognitive Decline, run by National Taiwan University Hospital at 2 sites 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Changes of Tower of Hanoi task(TOH) (time frame: Week 0, Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06110858.

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 20 Sep 2024.

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