Efficacy of Tinkering Activities in Individuals With Subjective Cognitive Decline

Subjective Cognitive Decline Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06110858
• Other study ID #: 202310004RIND
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: February 22, 2024

Study information

• Verified date: October 2023
• Source: National Taiwan University Hospital
• Contact: Hui-Fen Mao, M.S.
• Phone: 02-33668178
• Email: huifen02[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 22, 2024
• Est. primary completion date: January 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Training
• Subjective Cognitive Decline

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University	Taipei
Taiwan	School of Occupational Therapy, College of Medicine, National Taiwan University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Taiwan Science Education Center(NTSEC)

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Week 0, Week 6
Secondary	Changes of Remote Associates Test(RAT)	Scoring ranges from 0 to 30. A higher score indicates better remote associate ability.	Week 0, Week 6
Secondary	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.	Week 0, Week 6
Secondary	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.	Week 0, Week 6
Secondary	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.	Week 0, Week 6
Secondary	Changes of Subjective Cognitive Decline Scale(SCDS)	Scoring ranges from 14 to 70. A higher score indicates individuals perceive more subjective cognitive difficulties.	Week 0, Week 6
Secondary	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.	Week 0, Week 6
Secondary	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.	Week 0, Week 6
Secondary	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.	Week 0, Week 6
Secondary	Changes of Beck Depression Inventory II(BDI-II)	Scoring ranges from 0 to 63. A higher score indicates individuals perceive more severe depressive symptoms.	Week 0, Week 6
Secondary	Changes of Beck Anxiety Inventory(BAI)	Scoring ranges from 0 to 63. A higher score indicates individuals perceive more severe anxiety symptoms.	Week 0, Week 6
Secondary	Changes of General Self-Efficacy Scale(GSE)	Scoring ranges from 10 to 40. A higher score indicates better self-efficacy.	Week 0, Week 6