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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Impairment; Cognitive Dysfunction; Post Acute COVID-19 Syndrome; Post-Acute COVID-19
• Intervention / Treatment: Behavioral: CCT Long COVID

Detailed Description

A Phase I/II protocol is designed to determine the safety of a Computerized Cognitive Training (CCT) aimed at ameliorating the cognitive dysfunction often observed in persons with post-acute sequelae of COVID-19 (PASC). The Phase I/II trial also aims at establishing the maximum tolerated training time per session of the CCT and to explore the feasibility of such intervention. In Phase I, through a 3+3 design, a dose-escalation trial will be set. Participants will be tested across subsequent training blocks of 15 minutes each, reporting on the experienced fatigue or adverse effects after every block. The safe training dose will be set to a block before extreme fatigue or a notable adverse effect has been reported by two or more participants. Once a safety training time has been established, a group of participants will engage in a 15-day training effectiveness assessment. After an initial thorough pre-test assessment, the intervention protocol will start. An evaluation day and a training day will be interspersed so that participants will complete a total of 8 training sessions (days 1, 3, 5, 7, 9, 11, 13 and 15). After the final day of intervention, a post-test assessment session will be carried out.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jon Andoni Duñabeitia, PhD; Phone Number: 0034 900321322; Email: jdunabeitia@nebrija.es
• Study Contact Backup: Name: David Asensio; Email: dasensiob@alumnos.nebrija.es

Study Locations

• Spain
  • Madrid, Spain
    • Universidad Nebrija

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Computerized Cognitive Training; Individuals 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.

Behavioral: CCT Long COVID; 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.; Other Names: CogniFit CCT Long COVID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Computerized Cognitive Assessment	Complete cognitive evaluation based on Cognitive Assessment Battery (CogniFit Inc., San Francisco, USA).	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	Short version of the self-perceived global physical and mental health scale from the Patient-Reported Outcomes Measurement Information System (PROMIS v.1.2).	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	The Montreal Cognitive Assessment (MoCA).	In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).

Collaborators and Investigators

• Sponsor: Universidad Antonio de Nebrija
• Investigators: Principal Investigator: Jon Andoni Duñabeitia, PhD, Universidad Nebrija

Study record dates

Study Major Dates

• Study Start (Anticipated): October 18, 2022
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 16, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: cognitive dysfunction; PASC; post-acute sequelae of COVID-19; computerized cognitive training; brain training
• Additional Relevant MeSH Terms: Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurocognitive Disorders; Cognition Disorders; COVID-19; Cognitive Dysfunction
• Other Study ID Numbers: UNNE-2021-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No