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

Primary Purpose

Aging, Cognitive Decline

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
SCOT
CON
Sponsored by
Università degli Studi di Trento
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aging

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Centro Interdipartimentale Mente/Cervello - CIMeCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Social and Cognitive Online Training Group (SCOT)

Control Group (CON)

Arm Description

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

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

Outcomes

Primary Outcome Measures

The Tower of London test (Boccia et al. 2017)
Accuracy (% of correct answers)

Secondary Outcome Measures

Experimental task of emotion recognition
Accuracy (% of correct answers)
Italian Social and Emotional Loneliness Scale
Minimum value: 18; Maximum value: 72; Higher scores mean a worse outcome in terms of perceived loneliness.

Full Information

First Posted
June 14, 2021
Last Updated
August 20, 2021
Sponsor
Università degli Studi di Trento
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1. Study Identification

Unique Protocol Identification Number
NCT05023187
Brief Title
Social and Cognitive Online Training: the SCOT Project
Acronym
SCOT
Official Title
SCOT: An Online Intervention to Reduce Social Isolation and Promote Cognitive Well-being in the Elderly Population
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Università degli Studi di Trento

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Cognitive Decline

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social and Cognitive Online Training Group (SCOT)
Arm Type
Experimental
Arm Description
A group of participants randomly assigned to a social-cognitive online training through individual cognitive training sessions and group sessions to improve social functioning.
Arm Title
Control Group (CON)
Arm Type
Active Comparator
Arm Description
A group of participants randomly assigned to receive an active control intervention to compare performances with the experimental group.
Intervention Type
Behavioral
Intervention Name(s)
SCOT
Intervention Description
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.).
Intervention Type
Behavioral
Intervention Name(s)
CON
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Tower of London test (Boccia et al. 2017)
Description
Accuracy (% of correct answers)
Time Frame
Day 0 - Month 3
Secondary Outcome Measure Information:
Title
Experimental task of emotion recognition
Description
Accuracy (% of correct answers)
Time Frame
Day 0 - Month 3
Title
Italian Social and Emotional Loneliness Scale
Description
Minimum value: 18; Maximum value: 72; Higher scores mean a worse outcome in terms of perceived loneliness.
Time Frame
Day 0 - Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandra Dodich
Phone
0464 808162
Email
alessandra.dodich@unitn.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Costanza Papagno
Organizational Affiliation
Centro Interdipartimentale Mente/Cervello - CIMeC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alessandra Dodich
Organizational Affiliation
Centro Interdipartimentale Mente/Cervello - CIMeC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Interdipartimentale Mente/Cervello - CIMeC
City
Rovereto
State/Province
Trento
ZIP/Postal Code
38068
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Dodich
Phone
0464 808162
Email
alessandra.dodich@unitn.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Social and Cognitive Online Training: the SCOT Project

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