Efficacy of Tinkering Activities in Individuals With Subjective Cognitive Decline

NCT ID: NCT06110858

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-13
• Study Completion Date: 2024-08-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Tinkering Activities

Group Type: EXPERIMENTAL

Tinkering Activities

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan Science Education Center(NTSEC)

UNKNOWN

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University

Taipei, , Taiwan

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

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202310004RIND

Identifier Type: -

Identifier Source: org_study_id