Cognitive behavioral therapy, exercise training, and cognitive remediation for patients with post-Covid-19 condition
Protocol of an open-label randomized controlled trial
Bibliographic Data
Effective rehabilitation programs targeting transdiagnostic mechanisms of persistent physical symptoms are needed in long COVID. We present a transparency-focused description of the protocol of an open-label randomized controlled trial designed to evaluate the efficacy and tolerance of a multidisciplinary intensive rehabilitation program versus usual care. After a day-hospital multidisciplinary evaluation program including minimal psychoeducation and personalized recommendations, patients presenting with persistent symptoms after COVID-19 are proposed to participate to the study. The intervention consists of a 6-week rehabilitation program with groups of 3 to 5 patients attending three day-hospital sessions per week. The rehabilitation program combines adapted physical activity (three sessions per week with progressive exertion thresholds), cognitive remediation (two computer-based personalized sessions per week) and cognitive behavioral therapy (CBT, two sessions per week: one group session and one individual session). CBT sessions encompass psychoeducation, cognitive restructuring, behavioral activation and gradual exposure, and problem-solving skills. Our primary outcome is health-related quality of life (HRQoL) at 6 months, measured with the Physical Component Score (PCS) of the 12-item Short-Form Health Survey. The secondary outcomes are the Mental Component Score (MCS) at 6 months, PCS and MCS at 3 months, the main persistent symptoms (fatigue, dyspnea, cognitive complaints, pain) and associated psychological burden at 3 and 6 months, and patients’ satisfaction at 3 months. All included patients undergo an inclusion visit including a physical condition evaluation, a neuropsychological assessment, a first consultation with the CBT therapist, and the completion of several questionnaires for the secondary outcomes (Pichot scale, Borg scale, Cognitive Difficulties Scale, pain numeric scale, and Somatic Symptom disorder-B criteria scale). These evaluations are repeated at 3- and 6-month follow-up. All analyses will be performed in intention to treat following CONSORT Statement recommendations. Our goal is to demonstrate that a multidisciplinary intensive rehabilitation program combining adapted physical activity, cognitive remediation, and CBT leads to an improvement in HRQoL in the long term (i.e., six months after a multidisciplinary evaluation program including minimal psychoeducation and personalized recommendations) in patients with long COVID, while being feasible, acceptable, and safe. NCT number NCT05532904, registration date: 2022–09-07
Cognition · Cognitive behavioral therapy · Cognitive rehabilitation therapy · Cognitive remediation therapy · Neuropsychology · Psychoeducation · Quality of life (healthcare · Randomized controlled trial · COVID-19 and Mental Health · Intensive Care Unit Cognitive Disorders · Long-Term Effects of COVID-19 · Rehabilitation
Trail Making Test A and B
Cross-Validation of Item Selection and Scoring for the SF-12 Health Survey in Nine Countries
Wechsler Adult Intelligence Scale--Third Edition
The Montreal Cognitive Assessment, MoCA
A 12-Item Short-Form Health Survey
Development and Validation of the Somatic Symptom Disorder–B Criteria Scale (SSD-12)
Cardiopulmonary Rehabilitation in Long-Covid-19 Patients with Persistent Breathlessness and Fatigue
Personalized Computerized Training for Cognitive Dysfunction after Covid-19
| Citation velocity | historical |
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| Highly cited | No |