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MY-EDUC
Efficacité d'un Programme d'ETP Dans la myasthénie : étude de Preuve de Principe (MY-EDUC).
Sponsor study identifier
observational
62
0 countries
N/A
Study Start
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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. The 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. In 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). PRIMARY 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. METHODOLOGY (brief). Adaptation of the CBSM programme to the specific characteristics of myasthenia gravis:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 30, 2026
Actual (reported)April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 6, 2026
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Perceived stress
The Perceived Stress Scale (PSS), developed by Cohen et al. (1983), is a widely established psychological instrument designed to measure the degree to which situations in an individual's life are appraised as stressful. Rather than focusing on objective life events, it assesses the extent to which respondents find their lives unpredictable, uncontrollable, and overloaded. This study utilises the PSS-10, a 10-item version refined for its robust psychometric properties. Participants rate items on a five-point Likert scale (0 = Never to 4 = Very Often) based on their feelings and thoughts during the last month. Total scores range from 0 to 40, with higher values indicating greater perceived stress. The PSS is favoured in clinical trials for its brevity, high internal consistency, and sensitivity to change, providing a reliable measure of psychological distress and the effectiveness of behavioural stress management interventions.
T0: Initial assessment at least 7 days before intervention. T2: After intervention assessment (maximum 7 days after intervention). 73: Maintenance effect (4 weeks after the end of the intervention).
Anxiety
The Hospital Anxiety and Depression Scale (HADS), developed by Zigmond and Snaith (1983), is a validated 14-item self-report tool used to screen for anxiety and depression in clinical populations. It consists of two 7-item subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D). A significant advantage of the HADS is its exclusion of somatic symptoms, such as fatigue or sleep disturbance, which may be symptoms of physical conditions like Myasthenia Gravis rather than psychological distress. This prevents the overestimation of emotional disorders in medically ill patients. Items are rated on a 4-point Likert scale (0-3), with subscale scores ranging from 0 to 21. Typically, scores of 0-7 are considered normal, 8-10 indicate borderline cases, and 11-21 suggest a probable clinical disorder. Its high internal consistency and sensitivity to therapeutic change make it a robust metric for evaluating the psychological impact of the MY-EDUC intervention.
T0: Initial assessment at least 7 days before intervention. T2: After intervention assessment (maximum 7 days after intervention). 73: Maintenance effect (4 weeks after the end of the intervention).
Depression
The Hospital Anxiety and Depression Scale (HADS), developed by Zigmond and Snaith (1983), is a validated 14-item self-report tool used to screen for anxiety and depression in clinical populations. It consists of two 7-item subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D). A significant advantage of the HADS is its exclusion of somatic symptoms, such as fatigue or sleep disturbance, which may be symptoms of physical conditions like Myasthenia Gravis rather than psychological distress. This prevents the overestimation of emotional disorders in medically ill patients. Items are rated on a 4-point Likert scale (0-3), with subscale scores ranging from 0 to 21. Typically, scores of 0-7 are considered normal, 8-10 indicate borderline cases, and 11-21 suggest a probable clinical disorder. Its high internal consistency and sensitivity to therapeutic change make it a robust metric for evaluating the psychological impact of the MY-EDUC intervention.
T0: Initial assessment at least 7 days before intervention. T2: After intervention assessment (maximum 7 days after intervention). 73: Maintenance effect (4 weeks after the end of the intervention).
Health-related Quality of Life
T0: Initial assessment at least 7 days before intervention. T2: After intervention assessment (maximum 7 days after intervention). 73: Maintenance effect (4 weeks after the end of the intervention).
Adults living with myasthenia gravis
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. The intervention integrates several core evidence-based techniques: Cognitive Restructuring: Identifying and challenging dysfunctional thoughts related to MG to foster adaptive appraisals. Physiological Regulation: Training in relaxation techniques (e.g. progressive muscle relaxation) to reduce autonomic arousal. Coping Skills: Enhancing problem-solving, assertiveness, and time management to mitigate the impact of fatigue. Delivered 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Adults living with myasthenia gravis followed at University Hospital Grenoble Alpes.
Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
Roy-Byrne PP, Davidson KW, Kessler RC, Asmundson GJ, Goodwin RD, Kubzansky L, Lydiard RB, Massie MJ, Katon W, Laden SK, Stein MB. Anxiety disorders and comorbid medical illness. Gen Hosp Psychiatry. 2008 May-Jun;30(3):208-25. doi: 10.1016/j.genhosppsych.2007.12.006.
First Submitted
March 30, 2026
First Posted
April 6, 2026
Study Start
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2026
EstimatedContact the study team to confirm eligibility.
Philippot, P., Bouvard, M., Baeyens, C., & Dethier, V. (2015). Vers un protocole de traitement processuel et modulaire des troubles anxio- dépressifs. Journal de Thérapie Comportementale et Cognitive, 25(3), 106-116. https://doi.org/10.1016/j.jtcc.2015.07.001
Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Thompson-Hollands J, Carl JR, Gallagher MW, Barlow DH. Unified protocol for transdiagnostic treatment of emotional disorders: a randomized controlled trial. Behav Ther. 2012 Sep;43(3):666-78. doi: 10.1016/j.beth.2012.01.001. Epub 2012 Jan 18.
Chorpita BF, Weisz JR, Daleiden EL, Schoenwald SK, Palinkas LA, Miranda J, Higa-McMillan CK, Nakamura BJ, Austin AA, Borntrager CF, Ward A, Wells KC, Gibbons RD; Research Network on Youth Mental Health. Long-term outcomes for the Child STEPs randomized effectiveness trial: a comparison of modular and standard treatment designs with usual care. J Consult Clin Psychol. 2013 Dec;81(6):999-1009. doi: 10.1037/a0034200. Epub 2013 Aug 26.
Chen S, Forster S, Yang J, Yu F, Jiao L, Gates J, Wang Z, Liu H, Chen Q, Geldsetzer P, Wu P, Wang C, McMahon S, Barnighausen T, Adam M. Animated, video entertainment-education to improve vaccine confidence globally during the COVID-19 pandemic: an online randomized controlled experiment with 24,000 participants. Trials. 2022 Feb 19;23(1):161. doi: 10.1186/s13063-022-06067-5.
Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
Antoni MH, Wimberly SR, Lechner SC, Kazi A, Sifre T, Urcuyo KR, Phillips K, Smith RG, Petronis VM, Guellati S, Wells KA, Blomberg B, Carver CS. Reduction of cancer-specific thought intrusions and anxiety symptoms with a stress management intervention among women undergoing treatment for breast cancer. Am J Psychiatry. 2006 Oct;163(10):1791-7. doi: 10.1176/ajp.2006.163.10.1791.
Antoni MH, Cruess DG, Klimas N, Maher K, Cruess S, Kumar M, Lutgendorf S, Ironson G, Schneiderman N, Fletcher MA. Stress management and immune system reconstitution in symptomatic HIV-infected gay men over time: effects on transitional naive T cells (CD4(+)CD45RA(+)CD29(+)). Am J Psychiatry. 2002 Jan;159(1):143-5. doi: 10.1176/appi.ajp.159.1.143.
Antoni, M. H. (2003). Stress management intervention for women with breast cancer (p. xvi, 215). American Psychological Association. https://doi.org/10.1037/10488-000
Law C, Flaherty CV, Bandyopadhyay S. A Review of Psychiatric Comorbidity in Myasthenia Gravis. Cureus. 2020 Jul 14;12(7):e9184. doi: 10.7759/cureus.9184.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 6, 2026
Record last verified: 2026-03
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