Post-COVID ConditionSuperCAPNCT06315894
Supervised Computerized Active Program for People With Post-COVID Syndrome (SuperCAP Study)
A study testing SuperCAP Program in people with Post-COVID Condition, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-COVID Condition
- What is being tested?
- SuperCAP Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 3 Oct 2023to 5 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-COVID Condition
- Being tested
- SuperCAP Program
- Keywords
- Long COVID (LC), Post-Acute COVID-19 Syndrome (PACS), Post-Acute Sequelae of COVID-19 (PASC), Post-Acute Sequelae of SARS-CoV-2 (PASS), Post-COVID Condition (PCC), Post-COVID Syndrome (PCS)
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperCAP ProgramDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | People with post-COVID syndrome following the intervention Receives: Device: SuperCAP Program |
| Control | No intervention | People with post-COVID syndrome not following the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-reported Cognitive Functioning
Understanding and Communicating Scale (D1) from WHODAS 2.0 questionnaire. Scores from 0 to 20. Lower scores indicate better functioning, higher scores worse functioning.
Measured: From Baseline to Week 12
Secondary outcomes (6)
Change in Performance-based Cognitive Functioning
NPZ12, global neuropsychological measure. Scores from -5 to +5. Lower scores indicate worse functioning, higher scores better functioning.
Measured: From Baseline to Week 12
Change in Depression Symptoms
PHQ-9 questionnaire. Scores from 0 to 27. Lower scores indicate fewer symptoms, higher scores more symptoms.
Measured: From Baseline to Week 12
Change in Anxiety Symptoms
GAD-7 questionnaire. Scores from 0 to 21. Lower scores indicate fewer symptoms, higher scores more symptoms.
Measured: From Baseline to Week 12
Change in Daily Activities Functioning
IADL scale. Scores from 0 to 20. Lower scores indicate better functioning, higher scores worse functioning.
Measured: From Baseline to Week 12
Change in Physical Activity
IPAQ questionnaire. Scores from 0 to undetermined (total days, hours, minutes reported). Lower scores indicate worse activity, higher scores better activity.
Measured: From Baseline to Week 12
Change in Quality of Life
EuroQoL-5D scale. Scores from 0 to 100. Lower scores indicate worse quality of life, higher scores better quality of life.
Measured: From Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start3 Oct 2023
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recerca de la SIDA IrsiCaixa, Germans Trias i Pujol Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315894
- Sponsor's protocol ID
- PI-22-191
- Acronym
- SuperCAP
- Status last verified
- Dec 2025
- First submitted
- 15 Mar 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06315894
- Acronym / sponsor ID
- SuperCAP / PI-22-191
- Conditions
- Post-COVID Condition
- Keywords
- Long COVID (LC), Post-Acute COVID-19 Syndrome (PACS), Post-Acute Sequelae of COVID-19 (PASC), Post-Acute Sequelae of SARS-CoV-2 (PASS), Post-COVID Condition (PCC), Post-COVID Syndrome (PCS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Collaborators
- Institut de Recerca de la SIDA IrsiCaixa, Germans Trias i Pujol Hospital
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: SuperCAP ProgramPeople with post-COVID syndrome following the intervention |
| Control | No intervention | –People with post-COVID syndrome not following the intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuperCAP ProgramDistance 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. | Device | Experimental |
Primary outcome
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.
6 secondary outcomes
Change in Performance-based Cognitive Functioning
Time frame: From Baseline to Week 12
Change in Depression Symptoms
Time frame: From Baseline to Week 12
Change in Anxiety Symptoms
Time frame: From Baseline to Week 12
Change in Daily Activities Functioning
Time frame: From Baseline to Week 12
Change in Physical Activity
Time frame: From Baseline to Week 12
Change in Quality of Life
Time frame: From Baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
Related trials for Post-COVID Condition
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Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SuperCAP Program in people with Post-COVID Condition, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-reported Cognitive Functioning (time frame: From Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.