Efficacy of Tinkering Activities in Individuals With Subjective Cognitive Decline

NCT06110858 | Completed

• 1 other identifier: 202310004RIND
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Cognitive Training; Subjective Cognitive Decline

Keywords

Subjective Cognitive Decline; Cognitive Intervention; Executive Function; Problem Solving; Cognitive Flexibility

Outcome Measures

Primary Outcomes (3)

• 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.

  Week 0, Week 6

• Changes of Task Switching Paradigm(TS)

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

  Week 0, Week 6

• 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.

  Week 0, Week 6

Secondary Outcomes (12)

• Changes of Guilford's Alternative Uses Task(GAU)

  Week 0, Week 6

• Changes of Remote Associates Test(RAT)

  Week 0, Week 6

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

  Week 0, Week 6

• Changes of Computerized Everyday Cognitive Function Assessment(CECFA)

  Week 0, Week 6

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

  Week 0, Week 6

Study Arms (1)

Tinkering Activities

EXPERIMENTAL

Behavioral: Tinkering Activities

Interventions

Tinkering Activities BEHAVIORAL

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.

Tinkering Activities

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan Science Education Center(NTSEC): collaborator

Study Sites (2)

National Taiwan University

Taipei, Taiwan

Location

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

Taipei, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: November 13, 2023
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2024
• Last Updated: September 20, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)