Social and Cognitive Online Training: the SCOT Project

NCT ID: NCT05023187

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-19

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Aging Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

SCOT

Intervention Type BEHAVIORAL

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.).

Control Group (CON)

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

Group Type ACTIVE_COMPARATOR

CON

Intervention Type BEHAVIORAL

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.

Interventions

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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.).

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Università degli Studi di Trento

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Costanza Papagno

Role: STUDY_DIRECTOR

Centro Interdipartimentale Mente/Cervello - CIMeC

Alessandra Dodich

Role: PRINCIPAL_INVESTIGATOR

Centro Interdipartimentale Mente/Cervello - CIMeC

Locations

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Centro Interdipartimentale Mente/Cervello - CIMeC

Rovereto, Trento, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandra Dodich

Role: CONTACT

0464 808162

Facility Contacts

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Alessandra Dodich

Role: primary

0464 808162

References

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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.

Reference Type DERIVED
PMID: 38531149 (View on PubMed)

Other Identifiers

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Protocol 2020-036

Identifier Type: -

Identifier Source: org_study_id

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