Integrative Group-based Cognitive Rehabilitation Efficacy in Multiple Sclerosis: a Randomized Clinical Trial
cognitive remediation program: REHACOP
Maladies Auto-immunes+4
+ Maladies démyélinisantes
+ Maladies du Système Immunitaire
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 2013
Date à laquelle le premier participant a commencé l'étude.Assessment protocol: Patients underwent an extensive neuropsychological battery including test of attention, working memory, processing speed, verbal memory (learning and recall), verbal fluency and executive functioning. Sustained attention was measured using the Brief Test of Attention. For working memory, the Backward Digits subtest of the Weschler Adult Intelligence Scale III was used. Processing speed was assessed through the Symbol Digit Modalities Test, the three and six letter version of the Salthouse Perceptual Comparison Test and the Trail Making Test A. Verbal memory was determined based on the Hopkins Verbal Learning Test , learning and long-term recall performance. For verbal fluency, the Category (animals and supermarket) and Letter (P) Word Fluency Test from the Calibrated Ideational Fluency Assessment were utilized . Executive functioning was calculated by the word-color and interference scores of the Stroop Word-Color Test. Additionally, several test and scales were administered. The Expanded Disability Status Scale was used for rating the degree of neurologic impairment. Premorbid IQ was tested by The Accentuation Reading Test. Cognitive reserve was estimated with the Cognitive Reserve Questionnaire. The 15-item Geriatric Depression Scale was included to assess patients´ depressive symptoms. The Fatigue Severity Scale and the mental fatigue Visual Analogue Scale were included to evaluate physical and mental fatigue, respectively. Description of the intervention: REHACOP is a structured program using paper-pencil tasks and it is based on the principles of restoration, compensation and optimization with a gradually increasing level of cognitive effort and demand. REHACOP trains different cognitive domains, such as attention, memory, processing speed, language, executive functioning and social cognition. Additionally, the program includes one unit related to functional outcome: activities of daily living. REHACOP includes up to 300 different tasks hierarchically organized into at least three levels of difficulty and subtypes of abilities. Several tasks are timed, so processing speed is trained throughout various modules. Once a basic cognitive strategy has been trained and well acquired, the therapist transitions the program to the next level. The program format allows for either individual or group sessions (between 5 and 8 patients per group), although for the purpose of this study, group sessions were chosen. In this study, two psychologists conducted the REHACOP group attending 60-minute-long sessions 3 days per week at Multiple Sclerosis Association of Biscay (ADEMBI) (four groups). Specifically, REHACOP group remediation with MS patients consisted of: Attention unit (4 weeks) training sustained, selective, alternant and divided attention; Memory unit (3 weeks) focusing on visual and verbal learning, recall and recognizing memory, as well as in working memory; Language unit (3 weeks) including verbal fluency, grammar, syntax, vocabulary, verbal comprehension, abstract language; Executive functions unit (2 weeks) training development, planning and attainment of objectives; and Social cognition unit (1 week) exercising theory of mind, social reasoning and moral dilemmas.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.32 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 20 à 60 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site