Social and Cognitive Online Training: the SCOT Project

Aging Clinical Trial

— SCOT  

Official title:

SCOT: An Online Intervention to Reduce Social Isolation and Promote Cognitive Well-being in the Elderly Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023187
• Other study ID #: Protocol 2020-036
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2021
• Source: Università degli Studi di Trento
• Contact: Alessandra Dodich
• Phone: 0464 808162
• Email: alessandra.dodich[@]unitn.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Social isolation and reduced involvement in cognitive activities are associated with repercussions on cognitive well-being and health status in elderly adults. In particular, loneliness and social isolation represent risk factors in favouring cognitive decline and dementia. The Social Cognition Online Training (SCOT) project aims to evaluate the beneficial effects of an online intervention on social-cognitive functioning in healthy elderly subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

• Cognitively healthy subjects aged above 65 years old

• Montreal Cognitive Assessment (MoCA) equivalent score > 1 (Italian normative values)

Exclusion Criteria:

• Diagnosis of dementia, based on Diagnostic and Statistical Manual of Mental Disorders, FifthEdition (DSM-V)

• History of current or previous neuropsychiatric disorders;

• History of current or previous substance abuse;

Related Conditions & MeSH terms

• Aging
• Cognitive Decline
• Cognitive Dysfunction

Intervention

Behavioral:
• SCOT
A 8-week social and cognitive online training to improve both cognitive and social functioning, which includes 2 sessions (~45 minutes each) of individual cognitive training through the BrainHQ© program 2020 (BrainHQ© Posit Science) and a psycho-educational group session for each week (24 sessions in total). In the experimental intervention, all activities are focused on enhancing executive functions (working memory, processing speed, inhibitory control etc.) and social cognition abilities (identifying/recognizing facial expressions, styles attribution, drawing conclusions etc.).
• CON
A 8-week active control intervention consisting of 2 sessions (~45 minutes each) of cognitive stimulation exercises and a group session for each week (24 sessions in total) during which the various cognitive domains are deepened and the exercises carried out during the week are reviewed all together. The online control intervention has been specifically designed to increase the cognitive involvement of the subjects and to replicate the condition of exposure to social dynamics.

Locations

Country	Name	City	State
Italy	Centro Interdipartimentale Mente/Cervello - CIMeC	Rovereto	Trento

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Trento

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Tower of London test (Boccia et al. 2017)	Accuracy (% of correct answers)	Day 0 - Month 3
Secondary	Experimental task of emotion recognition	Accuracy (% of correct answers)	Day 0 - Month 3
Secondary	Italian Social and Emotional Loneliness Scale	Minimum value: 18; Maximum value: 72; Higher scores mean a worse outcome in terms of perceived loneliness.	Day 0 - Month 3