SuperCAP Program to Improve Cognition and Daily Functioning in Post-COVID-19 Condition

April 7, 2026 updated by: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 prmary 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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • 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 Backup

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Fundació Lluita contra les Infeccions - Hospital Universitari Germans Trias i Pujol
        • Contact:
          • Fundacion Fls De Lucha Contra El Sida
          • Phone Number: +34934978414
          • Email: info@fls-rs.com
        • Principal Investigator:
          • Anna Prats, MD, PhD

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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
Intervention / Treatment
Experimental: SuperCAP Arm
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.
Device: SuperCAP intervention program
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
Active Comparator: Standard of Care Arm
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.
Other: Psychoeducational intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline (week 0) to the post-intervention assessment (week 13).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change in EuroQol 5 Dimensions (EQ-5D) score from -0,654 to 1 where higher scores mean better outcome.
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).
Change in Instrumental Activities of Daily Living (IADL) score from 0 to 8 where higher score mean better outcomes.
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).
Change in Montreal Cognitive Assessment (MoCA) total score from 0 to 30 where higher scores mean better outcomes.
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).
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.
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)
Change in Patient Health Questionnaire-9 (PHQ-9) with scores from 0 to 27 where higher scores means worse outcomes.
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).
Change in Generalized Anxiety Disorder-7 (GAD-7) score from 0 to 21 where higher scores mean worse outcomes.
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).
Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) score from 0 to 144 where higher scores mean worse outcomes.
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).
Change in Montreal Cognitive Assessment (MoCA) score from 0 to 30 where higher scores mean better outcomes.
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).
Change in EuroQol 5 Dimensions (EQ-5D) score from -0,654 to 1 where higher scores mean better outcomes.
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)
Program adherence captured through platform telemetry.
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)
Usability measured by System Usability Score (SUS) score from 0 to 100 where higher scores mean better outcomes.
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).
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.
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).
Acceptability assessed using the Acceptability of Intervention Measure (AIM) scale which goes from 1 to 5 and higher scores mean better outcomes.
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).
Appropriateness assessed using Intervention Appropriateness Measure (IAM) scale which goes from 1 to 5 where higher scores mean better outcomes.
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).
Feasibility assessed using the Feasibility of Intervention Measure (FIM) scale which goes from 1 to 5 and higher scores mean better outcomes.
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).
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).
From post-intervention (week 13) to follow-up (week 25).

Collaborators and Investigators

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

Sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Collaborators

Fundació Institut Germans Trias i Pujol

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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SuperCAP Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

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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