NCT05023187

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

August 26, 2021

Status Verified

April 1, 2021

Enrollment Period

12 months

First QC Date

June 14, 2021

Last Update Submit

August 20, 2021

Conditions

AgingCognitive Decline

Outcome Measures

Primary Outcomes (1)

  • The Tower of London test (Boccia et al. 2017)

    Accuracy (% of correct answers)

    Day 0 - Month 3

Secondary Outcomes (2)

  • Experimental task of emotion recognition

    Day 0 - Month 3

  • Italian Social and Emotional Loneliness Scale

    Day 0 - Month 3

Study Arms (2)

Social and Cognitive Online Training Group (SCOT)

EXPERIMENTAL

A group of participants randomly assigned to a social-cognitive online training through individual cognitive training sessions and group sessions to improve social functioning.

Behavioral: SCOT

Control Group (CON)

ACTIVE COMPARATOR

A group of participants randomly assigned to receive an active control intervention to compare performances with the experimental group.

Behavioral: CON

Interventions

SCOTBEHAVIORAL

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.).

Social and Cognitive Online Training Group (SCOT)
CONBEHAVIORAL

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.

Control Group (CON)

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Cognitively healthy subjects aged above 65 years old
  • Montreal Cognitive Assessment (MoCA) equivalent score \> 1 (Italian normative values)

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Interdipartimentale Mente/Cervello - CIMeC

Rovereto, Trento, 38068, Italy

RECRUITING

Related Publications (1)

  • Funghi G, Meli C, Cavagna A, Bisoffi L, Zappini F, Papagno C, Dodich A. The Social and Cognitive Online Training (SCOT) project: A digital randomized controlled trial to promote socio-cognitive well-being in older adults. Arch Gerontol Geriatr. 2024 Jul;122:105405. doi: 10.1016/j.archger.2024.105405. Epub 2024 Mar 5.

    PMID: 38531149DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Costanza Papagno

    Centro Interdipartimentale Mente/Cervello - CIMeC

    STUDY DIRECTOR

  • Alessandra Dodich

    Centro Interdipartimentale Mente/Cervello - CIMeC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Dodich

CONTACT

0464 808162alessandra.dodich@unitn.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

August 26, 2021

Study Start

January 19, 2021

Primary Completion

December 31, 2021

Study Completion

February 28, 2022

Last Updated

August 26, 2021

Record last verified: 2021-04

Locations

IT(1)