The goal of this study is to determine whether the SuperCAP intervention program issuperior to control in reducing disability from baseline to the post-interventionassessment in people with Post-COVID-19 Condition.The main question it aims to answer is whether participants assigned to SuperCAPexperience a greater reduction in disability, defined as an improvement of at least 5points on the WHODAS 2.0 from baseline to the post-intervention visit, compared withparticipants in the control group.Participants assigned to the SuperCAP intervention will undergo a series of sessions thatinclude psychoeducation, adaptive cognitive training exercises, fatigue self-managementstrategies, and multidisciplinary content.
-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.
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
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.
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.
Fundació Lluita contra les Infeccions - Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Investigator: Fundacion Fls De Lucha Contra El Sida
Contact: +34934978414
info@fls-rs.com
Investigator: Anna Prats, MD, PhD
Anna Prats, MD, PhD
+34934657897
aprats@lluita.org
David Rovira
+34934978849
drovira@scienhub.org
Not Provided