Myasthenia Gravis (MG)MY-EDUCNCT07512375
The Effectiveness of an ETP Programme in Myasthenia Gravis: a Proof-of-concept Study.
An observational study of Myasthenia Gravis (MG), run by University Hospital, Grenoble.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myasthenia Gravis (MG)
- What is being tested?
- CBSM
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults living with myasthenia gravis followed at University Hospital Grenoble Alpes.
Who may be able to join
- Participant is aged 18 years or over (legal age of majority under French law).
- Participant has freely provided their non-opposition to participate in the study.
- Participant has a confirmed diagnosis of Myasthenia Gravis.
- 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.
Who cannot join
- 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.
- 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]).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacité d'un Programme d'ETP Dans la myasthénie : étude de Preuve de Principe (MY-EDUC).
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.
Read more
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:
- Focus groups: exploration of beliefs associated with stress in myasthenia gravis.
- 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).
Assessment of the feasibility of the MY-EDUC programme among groups of patients with myasthenia gravis.
PRIMARY 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.
RESEARCH PROCEDURE. 1.1. FOCUS GROUPS. Expert patients and partner patients. They will be contacted via the list maintained by the rare disease healthcare network.
'General public' patients. A call for participants will be displayed in the CHUGA waiting room and circulated by partner organisations to their members.
The 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.
1.2. 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).
Participant 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.
The 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.
1.2.3. 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.
1.2.4. 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.
Read the detailed description
- Background and Rationale Myasthenia Gravis (MG) is a rare autoimmune disorder of the neuromuscular junction (ORPHA 589), characterised by its chronic nature and the occurrence of fluctuating symptoms or flare-ups. Beyond the physical manifestations, the condition has a major impact on patients' quality of life. Recent data suggest that approximately 46.3% of patients suffer from anxiety disorders. While a Therapeutic Patient Education (TPE) programme entitled "Living better with myasthenia" is already established at Grenoble University Hospital, patients have expressed a clear requirement for specific modules addressing stress and anxiety management. The MY-EDUC programme aims to adapt the current TPE framework by integrating a stress management module based on Cognitive Behavioural Stress Management (CBSM). CBSM has proven effectiveness in various chronic pathologies for improving treatment adherence, quality of life, and coping strategies.
- Objectives Primary Objective: To evaluate the adaptation of the existing TPE programme after incorporating a CBSM-based stress management module (8 sessions) for adult patients with myasthenia gravis. Secondary Objectives: To assess the feasibility and acceptability of the MY-EDUC programme.
- Study Design and Methodology This is an observational, prospective, descriptive, and monocentric study (classified as RIPH3 under French regulations). The research is conducted in three phases: Phase 1 (Focus Groups): Exploration of stress-related beliefs with both expert patients and regular patients to adapt the session content. Phase 2 (Feasibility Study): Implementation of the programme with 40 patients (organised into 5 groups of 8 participants maximum).
- Description of the Intervention (MY-EDUC) The programme consists of 8 weekly sessions. It combines transversal stress management modules with modules specifically tailored to myasthenia. The approach is modular and transdiagnostic, designed to facilitate future national rollout within the FILNEMUS network.
- Outcome Measures and Assessments Assessments are performed electronically (via LimeSurvey) at several intervals: T0 (baseline), T1 (during the intervention via repeated ecological momentary assessments on smartphones), T2 (post-intervention), and T3 (1-month follow-up). Psychological Measures: Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS), and Brief COPE. Quality of Life: 36-Item Short Form Survey (SF-36). Ecological Assessments: Evaluation of stress and anxiety levels before and after each session (16 measurement points via PielsSurvey).
- Statistical Analysis Plan Data analysis will include: Descriptive statistics of the population's demographic and medical characteristics. Analysis of Covariance (ANCOVA) to compare means between groups at different time points. Repeated measures Analysis of Variance (ANOVA) to evaluate the sustainability of the effects. Multivariate linear regressions and network analyses to explore interactions between variables and identify subgroups of responders to the intervention.
- Expected Results The study intends to demonstrate that a TPE programme enhanced by a cognitive-behavioural approach reduces anxiety and depression while improving pain management and overall quality of life. Ultimately, this modular model could be transposed to other rare diseases, such as Amyotrophic Lateral Sclerosis (ALS).
- Conditions
- Myasthenia Gravis (MG)
- Being tested
- CBSM
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBSMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MY-EDUC | Adults living with myasthenia gravis Receives: Behavioral: CBSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Secondary outcomes (1)
Health-related Quality of Life
The 36-Item Short Form Health Survey (SF-36) is a globally recognised, self-reported instrument designed to assess health-related quality of life (HRQoL). It comprises 36 items covering eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These scales are further aggregated into two primary summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each domain is scored from 0 to 100, with higher scores indicating superior health status or functional ability. The SF-36 is highly valued in clinical research for its strong psychometric properties, including high internal consistency and sensitivity to therapeutic changes. In this study, it serves as a key outcome measure to evaluate the holistic impact of the intervention on patients' daily functioning and well-being.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Myasthenia Gravis (MG)Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire interuniversitaire de psychologie : personnalité, cognition et changement social - LIP-PC2S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512375
- Sponsor's protocol ID
- 38RC25.0025
- Acronym
- MY-EDUC
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 18509902Roy-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.
PubMed 18433653Philippot, 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.
PubMed 22697453Chorpita 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.
PubMed 23978169Chen 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.
PubMed 35183238Carver 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.
PubMed 16250744Antoni 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.
PubMed 17012691Antoni 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.
PubMed 11772706Antoni, 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.
PubMed 32802619
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacité d'un Programme d'ETP Dans la myasthénie : étude de Preuve de Principe (MY-EDUC).
- ClinicalTrials.gov ID
- NCT07512375
- Acronym / sponsor ID
- MY-EDUC / 38RC25.0025
- Conditions
- Myasthenia Gravis (MG)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Laboratoire interuniversitaire de psychologie : personnalité, cognition et changement social - LIP-PC2S
- Study start
- Apr 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Focus groups: exploration of beliefs associated with stress in myasthenia gravis.
- 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).
Assessment of the feasibility of the MY-EDUC programme among groups of patients with myasthenia gravis.
PRIMARY 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.
RESEARCH PROCEDURE. 1.1. FOCUS GROUPS. Expert patients and partner patients. They will be contacted via the list maintained by the rare disease healthcare network.
'General public' patients. A call for participants will be displayed in the CHUGA waiting room and circulated by partner organisations to their members.
The 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.
1.2. 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).
Participant 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.
The 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.
1.2.3. 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.
1.2.4. 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.
Detailed description
- Background and Rationale Myasthenia Gravis (MG) is a rare autoimmune disorder of the neuromuscular junction (ORPHA 589), characterised by its chronic nature and the occurrence of fluctuating symptoms or flare-ups. Beyond the physical manifestations, the condition has a major impact on patients' quality of life. Recent data suggest that approximately 46.3% of patients suffer from anxiety disorders. While a Therapeutic Patient Education (TPE) programme entitled "Living better with myasthenia" is already established at Grenoble University Hospital, patients have expressed a clear requirement for specific modules addressing stress and anxiety management. The MY-EDUC programme aims to adapt the current TPE framework by integrating a stress management module based on Cognitive Behavioural Stress Management (CBSM). CBSM has proven effectiveness in various chronic pathologies for improving treatment adherence, quality of life, and coping strategies.
- Objectives Primary Objective: To evaluate the adaptation of the existing TPE programme after incorporating a CBSM-based stress management module (8 sessions) for adult patients with myasthenia gravis. Secondary Objectives: To assess the feasibility and acceptability of the MY-EDUC programme.
- Study Design and Methodology This is an observational, prospective, descriptive, and monocentric study (classified as RIPH3 under French regulations). The research is conducted in three phases: Phase 1 (Focus Groups): Exploration of stress-related beliefs with both expert patients and regular patients to adapt the session content. Phase 2 (Feasibility Study): Implementation of the programme with 40 patients (organised into 5 groups of 8 participants maximum).
- Description of the Intervention (MY-EDUC) The programme consists of 8 weekly sessions. It combines transversal stress management modules with modules specifically tailored to myasthenia. The approach is modular and transdiagnostic, designed to facilitate future national rollout within the FILNEMUS network.
- Outcome Measures and Assessments Assessments are performed electronically (via LimeSurvey) at several intervals: T0 (baseline), T1 (during the intervention via repeated ecological momentary assessments on smartphones), T2 (post-intervention), and T3 (1-month follow-up). Psychological Measures: Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS), and Brief COPE. Quality of Life: 36-Item Short Form Survey (SF-36). Ecological Assessments: Evaluation of stress and anxiety levels before and after each session (16 measurement points via PielsSurvey).
- Statistical Analysis Plan Data analysis will include: Descriptive statistics of the population's demographic and medical characteristics. Analysis of Covariance (ANCOVA) to compare means between groups at different time points. Repeated measures Analysis of Variance (ANOVA) to evaluate the sustainability of the effects. Multivariate linear regressions and network analyses to explore interactions between variables and identify subgroups of responders to the intervention.
- Expected Results The study intends to demonstrate that a TPE programme enhanced by a cognitive-behavioural approach reduces anxiety and depression while improving pain management and overall quality of life. Ultimately, this modular model could be transposed to other rare diseases, such as Amyotrophic Lateral Sclerosis (ALS).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MY-EDUC | – | Behavioral: CBSMAdults living with myasthenia gravis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults living with myasthenia gravis followed at University Hospital Grenoble Alpes.
Key inclusion criteria (4 listed)
- Participant is aged 18 years or over (legal age of majority under French law).
- Participant has freely provided their non-opposition to participate in the study.
- Participant has a confirmed diagnosis of Myasthenia Gravis.
- 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.
Key exclusion criteria (2 listed)
- 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.
- 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]).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBSMCognitive 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. | Behavioural | MY-EDUC |
Primary outcome
Perceived stress
Time frame: 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).
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.
Anxiety
Time frame: 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).
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.
Depression
Time frame: 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).
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.
1 secondary outcome
Health-related Quality of Life
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 18509902Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
- Background: PubMed 18433653Roy-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.
- BackgroundPhilippot, 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
- Background: PubMed 22697453Farchione 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.
- Background: PubMed 23978169Chorpita 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.
- Background: PubMed 35183238Chen 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.
- Background: PubMed 16250744Carver 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.
- Background: PubMed 17012691Antoni 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.
- Background: PubMed 11772706Antoni 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.
- BackgroundAntoni, M. H. (2003). Stress management intervention for women with breast cancer (p. xvi, 215). American Psychological Association. https://doi.org/10.1037/10488-000
- Background: PubMed 32802619Law 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.
- Individual participant dataSharing planned: Yes
Related trials for Myasthenia Gravis (MG)
RecruitingPhase 2
ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis (MG)
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)
Myasthenia Gravis
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
RecruitingObservational study
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
Myasthenia Gravis, MG
RecruitingPhase 1
Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases
Muscular Diseases, Neuromuscular Manifestations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis (MG), run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damien OUDIN DOGLIONI, PhD (0615871407 ext. 0033, damien.oudin-doglioni@univ-grenoble-alpes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress (time frame: 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07512375, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.