Cognitive behavioral therapy, exercise training, and cognitive remediation for patients with post-COVID-19 condition: protocol of an open-label randomized controlled trial
BACKGROUND
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.
METHODS
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.
DISCUSSION
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.
TRIAL REGISTRATION
NCT number NCT05532904, registration date: 2022–09-07.
Web | DOI | PDF | BMC Psychology | Open Access
Gouraud, Clément; Ancellin-Geay, Agathe; Verot, Corentin; Bergeras, Isabelle; Poudevigne, Laura; Cormier, Lucile; Gilbert, Séverine; Limosin, Frédéric; Lacoste, Laurence; Ribayrol, Diane; Vedrines, Charles Ouazana; Pitron, Victor; Mesbahi-Ihadjadene, Karima; Abdoul, Hendy; Rousseau, Jessica; Kachaner, Alexandra; Ranque, Brigitte; Thoreux, Patricia; Lemogne, Cédric
BACKGROUND
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.
METHODS
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.
DISCUSSION
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.
TRIAL REGISTRATION
NCT number NCT05532904, registration date: 2022–09-07.
Web | DOI | PDF | BMC Psychology | Open Access
