Social and Cognitive Online Training: the SCOT Project (SCOT)

August 20, 2021 updated by: Università degli Studi di Trento

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Trento
      • Rovereto, Trento, Italy, 38068
        • Recruiting
        • Centro Interdipartimentale Mente/Cervello - CIMeC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Social and Cognitive Online Training Group (SCOT)
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

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.).
Active Comparator: Control Group (CON)
A group of participants randomly assigned to receive an active control intervention to compare performances with the experimental group.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Tower of London test (Boccia et al. 2017)
Time Frame: Day 0 - Month 3
Accuracy (% of correct answers)
Day 0 - Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experimental task of emotion recognition
Time Frame: Day 0 - Month 3
Accuracy (% of correct answers)
Day 0 - Month 3
Italian Social and Emotional Loneliness Scale
Time Frame: Day 0 - Month 3
Minimum value: 18; Maximum value: 72; Higher scores mean a worse outcome in terms of perceived loneliness.
Day 0 - Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Trento

Investigators

  • Study Director: Costanza Papagno, Centro Interdipartimentale Mente/Cervello - CIMeC
  • Principal Investigator: Alessandra Dodich, Centro Interdipartimentale Mente/Cervello - CIMeC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

August 20, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol 2020-036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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