Efficacy of Tinkering Activities in Individuals With Subjective Cognitive Decline

November 6, 2023 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University
        • Contact:
      • Taipei, Taiwan
        • Recruiting
        • School of Occupational Therapy, College of Medicine, National Taiwan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

    1. Experience subjective cognitive difficulties: answered "yes" to any questions in part I of the Subjective Cognitive Decline Scale(SCDS).
    2. 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tinkering Activities
Behavioral: Tinkering Activities
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Colour Trails Test-2(CTT-2)
Time Frame: Week 0, Week 6
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.
Week 0, Week 6
Changes of Tower of Hanoi task(TOH)
Time Frame: Week 0, Week 6
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.
Week 0, Week 6
Changes of Task Switching Paradigm(TS)
Time Frame: Week 0, Week 6
Scoring takes into account reaction time and accuracy. Faster reaction times and higher accuracy indicate better cognitive flexibility.
Week 0, Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Guilford's Alternative Uses Task(GAU)
Time Frame: Week 0, Week 6
Scoring includes criteria such as originality, fluency, flexibility and elaboration. A higher score indicates better creativity and divergent thinking.
Week 0, Week 6
Changes of Remote Associates Test(RAT)
Time Frame: Week 0, Week 6
Scoring ranges from 0 to 30. A higher score indicates better remote associate ability.
Week 0, Week 6
Changes of the Brief University of California San Diego Performance-Based Skills Assessment-Traditional Chinese Version(UPSA-B)
Time Frame: Week 0, Week 6
Scoring ranges from 0 to100. A higher score indicates better performance in instrumental activities of daily living.
Week 0, Week 6
Changes of Computerized Everyday Cognitive Function Assessment(CECFA)
Time Frame: Week 0, Week 6
Scoring takes into account both correct rate and time. A higher score indicates better performance in instrumental activities of daily living.
Week 0, Week 6
Changes of the Taiwanese version of the Montreal Cognitive Assessment(MoCA-T)
Time Frame: Week 0, Week 6
Scoring ranges from 0 to 30. A higher score indicates better objective cognitive function.
Week 0, Week 6
Changes of Subjective Cognitive Decline Scale(SCDS)
Time Frame: Week 0, Week 6
Scoring ranges from 14 to 70. A higher score indicates individuals perceive more subjective cognitive difficulties.
Week 0, Week 6
Changes of Word Lists Test(WLT) in Wechsler Memory Scale-3rd Edition(WMS-III)
Time Frame: Week 0, Week 6
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.
Week 0, Week 6
Changes of Family Pictures(FP) in Wechsler Memory Scale-3rd Edition(WMS-III)
Time Frame: Week 0, Week 6
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.
Week 0, Week 6
Changes of Colour Trails Test-1(CTT-1)
Time Frame: Week 0, Week 6
Scoring takes into account times, errors, near-misses and prompts. Fewer times, errors, near-misses and prompts indicate better attention.
Week 0, Week 6
Changes of Beck Depression Inventory II(BDI-II)
Time Frame: Week 0, Week 6
Scoring ranges from 0 to 63. A higher score indicates individuals perceive more severe depressive symptoms.
Week 0, Week 6
Changes of Beck Anxiety Inventory(BAI)
Time Frame: Week 0, Week 6
Scoring ranges from 0 to 63. A higher score indicates individuals perceive more severe anxiety symptoms.
Week 0, Week 6
Changes of General Self-Efficacy Scale(GSE)
Time Frame: Week 0, Week 6
Scoring ranges from 10 to 40. A higher score indicates better self-efficacy.
Week 0, Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Taiwan Science Education Center(NTSEC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 13, 2023

Primary Completion (Estimated)

January 22, 2024

Study Completion (Estimated)

February 22, 2024

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202310004RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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