Safety and Dosage of a Computerized Cognitive Training Program for Cognitive Dysfunction After COVID-19
CCTLongCOVID
Detailed Study on the Safety, Dosage and Feasibility of an Intervention Based on a Computerized Cognitive Training (CCT) for Individuals With Post-acute Sequelae of COVID-19 (PASC): A Phase I/II Trial
1 other identifier
interventional
20
1 country
1
Brief Summary
The goal of this Phase I/II clinical trial is to assess the safety and maximum tolerated training time of a self-administered computerized cognitive training (CCT) in individuals with cognitive dysfunction as a consequence of COVID-19 infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2022
CompletedFirst Posted
Study publicly available on registry
October 17, 2022
CompletedStudy Start
First participant enrolled
October 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedOctober 18, 2022
October 1, 2022
1 month
October 13, 2022
October 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Fatigue Level Questionnaire
Fatigue questionnaire adapted from the Brief Fatigue Inventory (Mendoza et al., 1999)
In Phase I, after each iteration of a 15-minute training.
Fatigue Level Questionnaire
Fatigue questionnaire adapted from the Brief Fatigue Inventory (Mendoza et al., 1999)
In Phase II, on even days (rest days of the intervention protocol).
Safety Level Questionnaire
Safety questionnaire aimed at exploring the existence of side effects and/or adverse events.
In Phase I, after each iteration of a 15-minute training.
Safety Level Questionnaire
Safety questionnaire aimed at exploring the existence of side effects and/or adverse events.
In Phase II, on even days (rest days of the intervention protocol).
Classification of side effect or adverse events
Interview adapted from the Patient-Reported Adverse Drug Event Questionnaire (de Vries et al., 2013).
In Phase I, after each iteration of a 15-minute training, only in case side effects or adverse events have been reported in the Safety Questionnaire.
Classification of side effect or adverse events
Interview adapted from the Patient-Reported Adverse Drug Event Questionnaire (de Vries et al., 2013).
In Phase II, on even days (rest days of the intervention protocol), only in case side effects or adverse events have been reported in the Safety Questionnaire.
Secondary Outcomes (3)
Computerized Cognitive Assessment
In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
Quality of Life Assessment
In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
Paper-and-pencil Cognitive Assessment
In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
Study Arms (1)
Computerized Cognitive Training
EXPERIMENTALIndividuals enrolled in Phase I and II will complete a Computerized Cognitive Training (CCT) based on an intervention with 15 different cognitive tasks in the form of games aimed at enhancing memory, attention, reasoning, perception and coordination skills. The CCT will be implemented in an app designed by CogniFit (CogniFit Inc., San Francisco, USA) to be used in tablets or mobile phones.
Interventions
A 15-day training protocol in which every 48 hours participants' complete a series of different cognitive tasks in the form of games selected among a pool of 12 games from CogniFit (CogniFit Inc., San Francisco, USA) whose difficulty level is tailored to each individual by the a patented Individualized Training System™ (ITS) software that automatically chooses the activities and difficulty levels for each person in every session.
Eligibility Criteria
You may qualify if:
- Adults between 25 and 55 years old.
- History of infection with COVID-19 at least 3 months prior to expression of interest with a valid diagnostic or antibody test.
- Presence of self-perceived cognitive dysfunction associated with post-acute sequelae of COVID-19 (concentration problems or brain fog).
You may not qualify if:
- Suicidal traits.
- Poor digital skills.
- Not having access to a mobile phone or tablet with Internet connection during the time of the intervention (only for Phase II).
- Not having 60 spare minutes per day to complete the intervention (only for Phase II).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Nebrija
Madrid, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Andoni Duñabeitia, PhD
Universidad Nebrija
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Research Center
Study Record Dates
First Submitted
October 13, 2022
First Posted
October 17, 2022
Study Start
October 18, 2022
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
October 18, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share