[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632337":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":10,"responsibleParty":27,"collaborators":29,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":9,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":10,"maxAge":10,"enrollmentInfo":41,"targetDuration":10,"studyType":44,"phases":10,"briefSummary":45,"conditions":46,"keywords":10,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":10},{"fullName":5,"class":6},"University Hospital, Grenoble","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MY-EDUC",null,"Adults living with myasthenia gravis",[13],"Behavioral: CBSM",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"BEHAVIORAL","CBSM","Cognitive Behavioural Stress Management (CBSM) is a structured, multimodal psychological intervention based on the transactional model of stress. It addresses the distress arising from the perceived imbalance between disease-related threats and available coping resources. CBSM aims to disrupt the cycle of physical symptoms and psychological strain.\n\nThe intervention integrates several core evidence-based techniques:\n\nCognitive Restructuring: Identifying and challenging dysfunctional thoughts related to MG to foster adaptive appraisals.\n\nPhysiological Regulation: Training in relaxation techniques (e.g. progressive muscle relaxation) to reduce autonomic arousal.\n\nCoping Skills: Enhancing problem-solving, assertiveness, and time management to mitigate the impact of fatigue.\n\nDelivered over eight weekly sessions, this transdiagnostic approach increases self-efficacy and improves quality of life by providing patients with practical tools to manage their condition effectively.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Damien OUDIN DOGLIONI, PhD","CONTACT","0615871407","0033","damien.oudin-doglioni@univ-grenoble-alpes.fr",{"type":28,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[30],{"name":31,"class":32},"Laboratoire interuniversitaire de psychologie : personnalité, cognition et changement social - LIP-PC2S","UNKNOWN","100632337","the-effectiveness-of-an-etp-programme-in-myasthenia-gravis-a-proof-of-concept-study-100632337",false,"NCT07512375","The Effectiveness of an ETP Programme in Myasthenia Gravis: a Proof-of-concept Study.","Efficacité d'un Programme d'ETP Dans la myasthénie : étude de Preuve de Principe (MY-EDUC).","Inclusion Criteria:\n\n* Participant is aged 18 years or over (legal age of majority under French law).\n* Participant has freely provided their non-opposition to participate in the study.\n* Participant has a confirmed diagnosis of Myasthenia Gravis.\n* Participant has sufficient proficiency in both spoken and written French to complete assessments and questionnaires, attend the programme sessions, and carry out home-based exercises.\n\nExclusion Criteria:\n\n* Participant presenting with one or more severe and established psychiatric disorders (e.g. severe depression, psychosis) that could interfere with the study's conduct, particularly the assessment of the primary and secondary endpoints.\n* Participant presenting with another chronic condition that induces fatigue. Protected persons (as defined by Articles L1121-5 to L1121-8 of the French Public Health Code \\[CSP\\]).","ALL",{"count":42,"type":43},62,"ESTIMATED","OBSERVATIONAL","CONTEXTE. Myasthenia gravis is a rare neuromuscular junction disorder affecting one in five thousand people (ORPHA 589). It is a chronic condition that progresses in episodes. Its severity varies, ranging from the invisible disability of fatigue to respiratory distress requiring intensive care. Currently, 270 patients with myasthenia gravis are being treated at Grenoble University Hospital in the Reference Centre for Rare Neuromuscular Diseases.\n\nThe impact of this disease on quality of life is significant, and medication alone is not sufficient. However, to date, there are virtually no psychosocial interventions for patients with myasthenia gravis and no studies evaluating their effectiveness.\n\nIn this context, the Cognitive Behavioural Stress Management (CBSM) programme is one of the stress management programmes applied to chronic health conditions whose effectiveness has already been demonstrated, particularly in terms of treatment adherence, quality of life, patients' coping strategies in the face of a chronic illness, and the outcomes of medical treatments (Antoni, 2003; Antoni et al., 2002, 2006).\n\nPRIMARY OBJECTIVE. Evaluation of the adaptation of an existing patient education programme, 'Living Better with Myasthenia', following the inclusion of an eight-session CBSM-based stress management module for adult patients living with myasthenia.\n\nMETHODOLOGY (brief). Adaptation of the CBSM programme to the specific characteristics of myasthenia gravis:\n\n1. Focus groups: exploration of beliefs associated with stress in myasthenia gravis.\n2. DELPHI group: validation of the adaptation of the ETP programme 'Living better with myasthenia gravis' implemented at CHUGA following the inclusion of a stress management module (CBSM).\n\nAssessment of the feasibility of the MY-EDUC programme among groups of patients with myasthenia gravis.\n\nPRIMARY OUTCOME MEASURE. Comparison of levels of anxiety, depression (HADS), perceived stress (PSS) and quality of life (SF-36) as self-reported by patients enrolled in the programme before and after the MY-EDUC intervention.\n\nRESEARCH PROCEDURE. 1.1. FOCUS GROUPS. Expert patients and partner patients. They will be contacted via the list maintained by the rare disease healthcare network.\n\n'General public' patients. A call for participants will be displayed in the CHUGA waiting room and circulated by partner organisations to their members.\n\nThe study will be presented to expert and partner patients, as well as to \"walk-in\" patients in the focus groups, using the contact details on the \"rare disease healthcare network\" lists and via posters. An information leaflet outlining the study and its objectives will be provided to them.\n\n1.2. FEASIBILITY AND ACCEPTABILITY STUDY OF THE MY-EDUC PROGRAMME. 1.2.1. Participant inclusion. Patient eligibility. The assessment of patient eligibility will be carried out by a specialist doctor from the CHUGA Rare Disease Centre of Excellence during a routine consultation with the patient (routine care).\n\nParticipant inclusion. Once patient eligibility has been verified, the investigator from the CHUGA Rare Disease Centre, or a person to whom they have delegated this task, will contact the patient to invite them to participate in the MY-EDUC study. They will provide a verbal explanation of the study and hand over an information sheet during a follow-up consultation with the patient as part of routine care. If the patient volunteers to participate, they will give their consent to participate.\n\nThe patient's consent will be recorded in the medical record. 1.2.2. Baseline assessment (T0). In the week leading up to the first session of the MY-EDUC programme, participants will complete the baseline assessment online (using the LimeSurvey platform - secure servers at the University of Grenoble Alpes) with questionnaires presented in a randomised order.\n\n1.2.3. Assessment during the intervention (T1). Based on repeated ecological measurements (Shiffman et al., 2008) via the study participants' mobile phones (two measurement points, before and after each session, randomly scheduled at least 36 hours apart, i.e. 16 measurements) using the free PielsSurvey software.\n\n1.2.4. Final assessments (T2 and T3). Within one week of the final session of the MY-EDUC programme (T2: week 10 after T0), participants will complete a set of questionnaires electronically (using the LimeSurvey platform - secure servers at the University of Grenoble Alpes), with the validated questionnaires presented in a randomised order.",[47],"Myasthenia Gravis (MG)","NOT_YET_RECRUITING","2026-03-30",{"date":51,"type":52},"2026-04-06","ACTUAL",{"date":54,"type":43},"2026-04",{"date":56,"type":43},"2027-06",{"name":5,"class":6}]