Clinical trial NCT06110858: Efficacy of Tinkering Activities in Individuals With Subjective Cognitive Decline
Official title: The Efficacy of Tinkering Activity Based Cognitive Intervention to Improve Executive Function in Individuals With Subjective Cognitive Decline：A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Training
Subjective Cognitive Decline
Keywords: Subjective Cognitive Decline
Cognitive Intervention
Executive Function
Problem Solving
Cognitive Flexibility
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan Science Education Center(NTSEC)
First posted: 2023-11-01
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Changes of Tower of Hanoi task(TOH)
timeFrame: Week 0, Week 6
measure: Changes of Task Switching Paradigm(TS)
timeFrame: Week 0, Week 6
measure: Changes of Colour Trails Test-2(CTT-2)
timeFrame: Week 0, Week 6
Secondary outcomes:
measure: Changes of Guilford's Alternative Uses Task(GAU)
timeFrame: Week 0, Week 6
measure: Changes of Remote Associates Test(RAT)
timeFrame: Week 0, Week 6
measure: Changes of the Brief University of California San Diego Performance-Based Skills Assessment-Traditional Chinese Version(UPSA-B)
timeFrame: Week 0, Week 6
measure: Changes of Computerized Everyday Cognitive Function Assessment(CECFA)
timeFrame: Week 0, Week 6
measure: Changes of the Taiwanese version of the Montreal Cognitive Assessment(MoCA-T)
timeFrame: Week 0, Week 6
measure: Changes of Subjective Cognitive Decline Scale(SCDS)
timeFrame: Week 0, Week 6
measure: Changes of Word Lists Test(WLT) in Wechsler Memory Scale-3rd Edition(WMS-III)
timeFrame: Week 0, Week 6
measure: Changes of Family Pictures(FP) in Wechsler Memory Scale-3rd Edition(WMS-III)
timeFrame: Week 0, Week 6
measure: Changes of Colour Trails Test-1(CTT-1)
timeFrame: Week 0, Week 6
measure: Changes of Beck Depression Inventory II(BDI-II)
timeFrame: Week 0, Week 6
measure: Changes of Beck Anxiety Inventory(BAI)
timeFrame: Week 0, Week 6
measure: Changes of General Self-Efficacy Scale(GSE)
timeFrame: Week 0, Week 6
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
city: Taipei
country: Taiwan
facility: School of Occupational Therapy, College of Medicine, National Taiwan University
Study officials:
References: