Post COVID ConditionNCT07530757
SuperCAP Program to Improve Cognition and Daily Functioning in Post-COVID-19 Condition
A study testing SuperCAP intervention program and Psychoeducational intervention 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
The goal of this study is to determine whether the SuperCAP intervention program is superior to control in reducing disability from baseline to the post-intervention assessment in people with Post-COVID-19 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 intervention program and Psychoeducational intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of PCC, defined as the presence of three or more symptoms associated with COVID-19 infection for at least three months, not explained by other diseases.
- Age 18 to 65 years.
- Willingness to participate in an app-based intervention program aimed at improving daily Functioning in People Living with PCC.
- Evidence of patient-reported cognitive difficulties emerging after COVID-19, operationalized as a WHODAS 2.0 Cognition Domain (D1) score > 6 at baseline via RedCAP.
- Digital proficiency defined as scoring ≥4 on MDPQ-16 item 2a (sending emails) and ≥3 on item 6a (using the device's app store) via RedCAP.
- Self-reported ability to use a mobile application for approximately 15 minutes per day, 5 days per week, considering their current symptoms.
- Possession of a personal smartphone compatible with the study mobile application (eSalut), with sufficient storage space and operating system version required for installation.
Who cannot join
- Inability to undergo neuropsychological tests or additional assessments.
- Prior use of the SuperCAP program.
- Current participation in a trial or program aimed at improving PCC symptoms.
- Any condition that, in the investigator's opinion, could make participation unsafe, complicate interpretation of study results, interfere with achievement of study objectives, or otherwise affect the participant's ability to complete the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Fundació Lluita contra les Infeccions - Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Fundacion Fls De Lucha Contra El Sida, +34934978414, info@fls-rs.com
Anna Prats, MD, PhD
About this study
Official title: Randomized Controlled Trial to Assess the Efficacy of a Supervised Computerized Active Program (SuperCAP) to Improve Cognition and Daily Functioning in People With Post-COVID-19 Condition
The goal of this study is to determine whether the SuperCAP intervention program is superior to control in reducing disability from baseline to the post-intervention assessment in people with Post-COVID-19 Condition.
The main question it aims to answer is whether participants assigned to SuperCAP experience a greater reduction in disability, defined as an improvement of at least 5 points on the WHODAS 2.0 from baseline to the post-intervention visit, compared with participants in the control group.
Participants assigned to the SuperCAP intervention will undergo a series of sessions that include psychoeducation, adaptive cognitive training exercises, fatigue self-management strategies, and multidisciplinary content.
Read the detailed description
-COVID-19 Condition (PCC) is a major public health challenge, with cognitive impairment and fatigue among its most prevalent and disabling symptoms, leading to substantial limitations in quality of life and daily functioning. Digital health solutions provide an opportunity to expand access to structured, evidence-informed care. SuperCAP was developed as a multidisciplinary digital therapeutic program to support cognitive and functional recovery in individuals with PCC. A randomized pilot study demonstrated its feasibility and acceptability, supporting the conduct of a larger randomized controlled trial to evaluate its efficacy on disability and cognitive outcomes.
Participants will be randomized (1:1) to receive the digital intervention (SuperCAP) or Standard of Care (SoC) during 13 weeks, followed by a 12-week observation period.
The primary objective is to determine whether the SuperCAP intervention program is superior to control in reducing disability from baseline to the post-intervention assessment.
The secondary objectives include evaluating the effects of SuperCAP on quality of life, daily functioning, cognitive and emotional outcomes, the durability of these effects at follow-up, and the feasibility and acceptability of program implementation.
- Conditions
- Post COVID Condition
- Being tested
- SuperCAP intervention program, Psychoeducational intervention
- Keywords
- Post COVID Condition, Long COVID, SuperCAP
- 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 intervention programDevice
The SuperCAP (Supervised Computerized Active Program) is an online, multidimensional therapeutic program integrated into eSalut, the Catalan Institute of Health's digital platform, designed to improve daily functioning and quality of life in individuals with PCC who experience cognitive symptoms
Psychoeducational interventionOther
The psychoeducational intervention is a non-pharmacological interventions that teach practical strategies to help individuals with the cognitive disorders and fatigue associated with long COVID and provide general guidelines on how to manage these symptoms so that they have the least possible impact on daily life.
| Study group | Role | What they receive |
|---|---|---|
| SuperCAP Arm | Experimental | The intervention comprises 60 sessions delivered over 12 weeks (5 sessions/week), with flexibility up to 15 weeks to accommodate symptom fluctuation. Each session follows a standardized structure to reinforce self-management and cognitive engagement. The sessions includes psychoeducation, adaptive cognitive training exercises, fatigue self-management strategies, and multidisciplinary content. Receives: Device: SuperCAP intervention program |
| Standard of Care Arm | Active comparator | The Standard of Care consists in a psychoeducational intervention on the cognitive disorders and fatigue associated with long COVID, and general guidelines on how to manage these symptoms so that they have the least possible impact on daily life. Receives: Other: Psychoeducational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether the SuperCAP intervention program is superior to control in reducing disability.
Change in total WHODAS 2.0 score from baseline to post-intervention.
Measured: From baseline (week 0) to the post-intervention assessment (week 13).
Secondary outcomes (16)
To assess whether the SuperCAP intervention leads to greater improvements in quality of life compared with control.
Change in EuroQol 5 Dimensions (EQ-5D) score from -0,654 to 1 where higher scores mean better outcome.
Measured: From baseline (week 0) to post-intervention (week 13)
To assess whether the SuperCAP intervention leads to greater improvements in instrumental daily functioning compared with control.
Change in Instrumental Activities of Daily Living (IADL) score from 0 to 8 where higher score mean better outcomes.
Measured: From baseline (week 0) to post-intervention (week 13).
To evaluate whether the intervention improves performance-based cognitive measures.
Change in Montreal Cognitive Assessment (MoCA) total score from 0 to 30 where higher scores mean better outcomes.
Measured: From baseline (week 0) to post-intervention (week 13).
To evaluate whether the intervention improves patient-reported cognitive functioning.
Change in subjective cognitive functioning in daily life by Memory Failures of Everyday Questionnaire (MFE-30) with scores from 0 to 120 where higher scores mean worse outcomes.
Measured: From baseline (week 0) to post-intervention (week 13).
To assess reductions in depressive symptoms following the intervention.
Change in Patient Health Questionnaire-9 (PHQ-9) with scores from 0 to 27 where higher scores means worse outcomes.
Measured: From baseline (week 0) to post-intervention (week 13)
To assess reductions in anxiety symptoms following the intervention.
Change in Generalized Anxiety Disorder-7 (GAD-7) score from 0 to 21 where higher scores mean worse outcomes.
Measured: From baseline (week 0) to post-intervention (week 13).
To determine whether improvements in functional outcomes are sustained at follow-up.
Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) score from 0 to 144 where higher scores mean worse outcomes.
Measured: From post-intervention (week 13) to follow-up (week 25).
To determine whether improvements in cognitive outcomes are sustained at follow-up.
Change in Montreal Cognitive Assessment (MoCA) score from 0 to 30 where higher scores mean better outcomes.
Measured: From post-intervention (week 13) to follow-up (week 25).
To determine whether improvements in emotional outcomes are sustained at follow-up.
Change in EuroQol 5 Dimensions (EQ-5D) score from -0,654 to 1 where higher scores mean better outcomes.
Measured: From post-intervention (week 13) to follow-up (week 25).
To evaluate feasibility of implementation, including adherence to the program.
Program adherence captured through platform telemetry.
Measured: From post-intervention (week 13) to follow-up (week 25)
To evaluate feasibility of implementation, including usability.
Usability measured by System Usability Score (SUS) score from 0 to 100 where higher scores mean better outcomes.
Measured: From post-intervention (week 13) to follow-up (week 25)
To evaluate feasibility of implementation, including satisfaction and retention.
Participant satisfaction and perceived benefit will be assessed through a brief set of items evaluating overall satisfaction with the program, perceived usefulness and perceived improvement in daily functioning.
Measured: From post-intervention (week 13) to follow-up (week 25).
To explore indicators of acceptability.
Acceptability assessed using the Acceptability of Intervention Measure (AIM) scale which goes from 1 to 5 and higher scores mean better outcomes.
Measured: From post-intervention (week 13) to follow-up (week 25).
To explore indicators of appropriateness.
Appropriateness assessed using Intervention Appropriateness Measure (IAM) scale which goes from 1 to 5 where higher scores mean better outcomes.
Measured: From post-intervention (week 13) to follow-up (week 25).
To explore indicators of implementation.
Feasibility assessed using the Feasibility of Intervention Measure (FIM) scale which goes from 1 to 5 and higher scores mean better outcomes.
Measured: From post-intervention (week 13) to follow-up (week 25).
To explore preliminary economic feasibility indicators.
Economic feasibility will be explored through resource-use variables professional time required for support or monitoring, number and type of user support contacts or technical incidents requiring intervention).
Measured: From post-intervention (week 13) to follow-up (week 25).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start15 Jul 2026
- Primary completionNov 2026 (estimated)
- Study completionApr 2027 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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
- Fundació Institut Germans Trias i Pujol
- Responsible party
- Sponsor
- Investigators
- Anna Prats, PhD, Principal investigator, Fundació Lluita contra les Infeccions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530757
- Sponsor's protocol ID
- SuperCAP Trial
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared publicly due to the nature of the study, the limited sample size, and the sensitive nature of the data related to cognitive status of the participants.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Assess the Efficacy of a Supervised Computerized Active Program (SuperCAP) to Improve Cognition and Daily Functioning in People With Post-COVID-19 Condition
- ClinicalTrials.gov ID
- NCT07530757
- Acronym / sponsor ID
- SuperCAP Trial
- Conditions
- Post COVID Condition
- Keywords
- Post COVID Condition, Long COVID, SuperCAP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- 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
- Fundació Institut Germans Trias i Pujol
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 15 Apr 2026 (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.
The goal of this study is to determine whether the SuperCAP intervention program is superior to control in reducing disability from baseline to the post-intervention assessment in people with Post-COVID-19 Condition.
The main question it aims to answer is whether participants assigned to SuperCAP experience a greater reduction in disability, defined as an improvement of at least 5 points on the WHODAS 2.0 from baseline to the post-intervention visit, compared with participants in the control group.
Participants assigned to the SuperCAP intervention will undergo a series of sessions that include psychoeducation, adaptive cognitive training exercises, fatigue self-management strategies, and multidisciplinary content.
Detailed description
-COVID-19 Condition (PCC) is a major public health challenge, with cognitive impairment and fatigue among its most prevalent and disabling symptoms, leading to substantial limitations in quality of life and daily functioning. Digital health solutions provide an opportunity to expand access to structured, evidence-informed care. SuperCAP was developed as a multidisciplinary digital therapeutic program to support cognitive and functional recovery in individuals with PCC. A randomized pilot study demonstrated its feasibility and acceptability, supporting the conduct of a larger randomized controlled trial to evaluate its efficacy on disability and cognitive outcomes.
Participants will be randomized (1:1) to receive the digital intervention (SuperCAP) or Standard of Care (SoC) during 13 weeks, followed by a 12-week observation period.
The primary objective is to determine whether the SuperCAP intervention program is superior to control in reducing disability from baseline to the post-intervention assessment.
The secondary objectives include evaluating the effects of SuperCAP on quality of life, daily functioning, cognitive and emotional outcomes, the durability of these effects at follow-up, and the feasibility and acceptability of program implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SuperCAP Arm | Experimental | Device: SuperCAP intervention programThe intervention comprises 60 sessions delivered over 12 weeks (5 sessions/week), with flexibility up to 15 weeks to accommodate symptom fluctuation. Each session follows a standardized structure to reinforce self-management and cognitive engagement. The sessions includes psychoeducation, adaptive cognitive training exercises, fatigue self-management strategies, and multidisciplinary content. |
| Standard of Care Arm | Active comparator | Other: Psychoeducational interventionThe Standard of Care consists in a psychoeducational intervention on the cognitive disorders and fatigue associated with long COVID, and general guidelines on how to manage these symptoms so that they have the least possible impact on daily life. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of PCC, defined as the presence of three or more symptoms associated with COVID-19 infection for at least three months, not explained by other diseases.
- Age 18 to 65 years.
- Willingness to participate in an app-based intervention program aimed at improving daily Functioning in People Living with PCC.
- Evidence of patient-reported cognitive difficulties emerging after COVID-19, operationalized as a WHODAS 2.0 Cognition Domain (D1) score > 6 at baseline via RedCAP.
- Digital proficiency defined as scoring ≥4 on MDPQ-16 item 2a (sending emails) and ≥3 on item 6a (using the device's app store) via RedCAP.
Key exclusion criteria (4 listed)
- Inability to undergo neuropsychological tests or additional assessments.
- Prior use of the SuperCAP program.
- Current participation in a trial or program aimed at improving PCC symptoms.
- Any condition that, in the investigator's opinion, could make participation unsafe, complicate interpretation of study results, interfere with achievement of study objectives, or otherwise affect the participant'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 intervention programThe SuperCAP (Supervised Computerized Active Program) is an online, multidimensional therapeutic program integrated into eSalut, the Catalan Institute of Health's digital platform, designed to improve daily functioning and quality of life in individuals with PCC who experience cognitive symptoms | Device | SuperCAP Arm |
| Psychoeducational interventionThe psychoeducational intervention is a non-pharmacological interventions that teach practical strategies to help individuals with the cognitive disorders and fatigue associated with long COVID and provide general guidelines on how to manage these symptoms so that they have the least possible impact on daily life. | Other | Standard of Care Arm |
Primary outcome
To determine whether the SuperCAP intervention program is superior to control in reducing disability.
Time frame: From baseline (week 0) to the post-intervention assessment (week 13).
Change in total WHODAS 2.0 score from baseline to post-intervention.
16 secondary outcomes
To assess whether the SuperCAP intervention leads to greater improvements in quality of life compared with control.
Time frame: From baseline (week 0) to post-intervention (week 13)
To assess whether the SuperCAP intervention leads to greater improvements in instrumental daily functioning compared with control.
Time frame: From baseline (week 0) to post-intervention (week 13).
To evaluate whether the intervention improves performance-based cognitive measures.
Time frame: From baseline (week 0) to post-intervention (week 13).
To evaluate whether the intervention improves patient-reported cognitive functioning.
Time frame: From baseline (week 0) to post-intervention (week 13).
To assess reductions in depressive symptoms following the intervention.
Time frame: From baseline (week 0) to post-intervention (week 13)
To assess reductions in anxiety symptoms following the intervention.
Time frame: From baseline (week 0) to post-intervention (week 13).
To determine whether improvements in functional outcomes are sustained at follow-up.
Time frame: From post-intervention (week 13) to follow-up (week 25).
To determine whether improvements in cognitive outcomes are sustained at follow-up.
Time frame: From post-intervention (week 13) to follow-up (week 25).
To determine whether improvements in emotional outcomes are sustained at follow-up.
Time frame: From post-intervention (week 13) to follow-up (week 25).
To evaluate feasibility of implementation, including adherence to the program.
Time frame: From post-intervention (week 13) to follow-up (week 25)
To evaluate feasibility of implementation, including usability.
Time frame: From post-intervention (week 13) to follow-up (week 25)
To evaluate feasibility of implementation, including satisfaction and retention.
Time frame: From post-intervention (week 13) to follow-up (week 25).
To explore indicators of acceptability.
Time frame: From post-intervention (week 13) to follow-up (week 25).
To explore indicators of appropriateness.
Time frame: From post-intervention (week 13) to follow-up (week 25).
To explore indicators of implementation.
Time frame: From post-intervention (week 13) to follow-up (week 25).
To explore preliminary economic feasibility indicators.
Time frame: From post-intervention (week 13) to follow-up (week 25).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared publicly due to the nature of the study, the limited sample size, and the sensitive nature of the data related to cognitive status of the participants.
Related trials for Post COVID Condition
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Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
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Long COVID
RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
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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.
Anna Prats, PhD principal investigator
Fundació Lluita contra les Infeccions
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 intervention program and Psychoeducational intervention 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Prats, PhD (+34934657897, aprats@lluita.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether the SuperCAP intervention program is superior to control in reducing disability. (time frame: From baseline (week 0) to the post-intervention assessment (week 13).). 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 11 Sep 2026.