NCT07530757

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

March 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 15, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

March 31, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

Post COVID ConditionLong COVIDSuperCAP

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    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.

    From baseline (week 0) to post-intervention (week 13).

  • To evaluate whether the intervention improves performance-based cognitive measures.

    From baseline (week 0) to post-intervention (week 13).

  • To evaluate whether the intervention improves patient-reported cognitive functioning.

    From baseline (week 0) to post-intervention (week 13).

  • To assess reductions in depressive symptoms following the intervention.

    From baseline (week 0) to post-intervention (week 13)

  • +11 more secondary outcomes

Study Arms (2)

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.

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.

Other: Psychoeducational intervention

Interventions

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.

Standard of Care Arm

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

SuperCAP Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundació Lluita contra les Infeccions - Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Anna Prats, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 15, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

April 15, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations