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

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.

-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.

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.