Supervised Computerized Active Program for People With Post-COVID Syndrome (SuperCAP Study) (SuperCAP)

December 23, 2025 updated by: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Design and Implementation of a Supervised Computerized Active Program (SuperCAP) for Improvement of Cognitive, Emotional, and Functional Status in People With Post-COVID Syndrome. SuperCAP Study

SuperCAP study is a project aimed at designing and implementing an online program for improvement of cognitive, emotional, and functional status in post-COVID condition.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

SuperCAP study will include 2 stages.

Stage 1 will involve the composition of a focus group previous to the effectiveness study development.

The work with this focus group will have several aims, among them, mainly, to participate in the design of the intervention program, and to provide feedback on the study follow-up.

Stage 2 will include the effectiveness study. This stage will comprise the initiation of the intervention program, study follow-up, and dissemination of the results in the end of the project.

Two study groups will participate: the Intervention Group and the Control Group.

The Intervention Group will be comprised by people with post-COVID condition who will follow the intervention program proposed.

The Control Group will be comprised by people with post-COVID condition who will not follow the program.

Both groups will fulfill the same study participation criteria.

The intervention will consist of the follow-up of a distance program via mobile/tablet. This program will integrate different games and exercises always with the objective of stimulating the cognitive functioning and the emotional status.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Germans Trias i Pujol Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Presenting Post-COVID Syndrome, defined as presenting 3 or more symptoms associated with post-COVID condition for at least 3 months.
  • Age of 18-65 years old.
  • Presence of self-reported cognitive complaints associated with post-COVID infection.
  • Positive and favorable attitude on the use of electronic devices.
  • Will to participate in a stimulation program for improvement of cognitive symptoms.
  • Availability of cell phone and computer or tablet with the minimum technical features considered.

Exclusion Criteria:

  • Inability to undergo the neuropsychological tests or complementary study assessments.
  • Current participation in a trial or program for improvement of post-COVID symptoms.
  • Any condition that in the opinion of the investigator would make study participation unsafe, complicate interpretation of study outcome data, interfere with achieving the study objectives, or otherwise could impair the subject's ability to complete the study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
People with post-COVID syndrome following the intervention
Device: SuperCAP Program

Distance program including tasks and exercises to improve cognitive, emotional, and functional status.

The intervention will be applied via cell phone and will have a duration of 3 months (12 weeks).

Tasks and exercises will be performed 5 days per week. Contents of the program will include daily exercises, daily games, daily videos, and weekly videos.

They will address cognitive functions, daily habits, and lifestyle factors in general.

Compliance will be monitored to control the adherence to the intervention. The program has been designed specifically for people with post-COVID syndrome.
No Intervention: Control
People with post-COVID syndrome not following the intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Self-reported Cognitive Functioning
Time Frame: From Baseline to Week 12
Understanding and Communicating Scale (D1) from WHODAS 2.0 questionnaire. Scores from 0 to 20. Lower scores indicate better functioning, higher scores worse functioning.
From Baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Performance-based Cognitive Functioning
Time Frame: From Baseline to Week 12
NPZ12, global neuropsychological measure. Scores from -5 to +5. Lower scores indicate worse functioning, higher scores better functioning.
From Baseline to Week 12
Change in Depression Symptoms
Time Frame: From Baseline to Week 12
PHQ-9 questionnaire. Scores from 0 to 27. Lower scores indicate fewer symptoms, higher scores more symptoms.
From Baseline to Week 12
Change in Anxiety Symptoms
Time Frame: From Baseline to Week 12
GAD-7 questionnaire. Scores from 0 to 21. Lower scores indicate fewer symptoms, higher scores more symptoms.
From Baseline to Week 12
Change in Daily Activities Functioning
Time Frame: From Baseline to Week 12
IADL scale. Scores from 0 to 20. Lower scores indicate better functioning, higher scores worse functioning.
From Baseline to Week 12
Change in Physical Activity
Time Frame: From Baseline to Week 12
IPAQ questionnaire. Scores from 0 to undetermined (total days, hours, minutes reported). Lower scores indicate worse activity, higher scores better activity.
From Baseline to Week 12
Change in Quality of Life
Time Frame: From Baseline to Week 12
EuroQoL-5D scale. Scores from 0 to 100. Lower scores indicate worse quality of life, higher scores better quality of life.
From Baseline to Week 12

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Germans Trias i Pujol Hospital
Institut de Recerca de la SIDA IrsiCaixa

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI-22-191

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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