Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-26 @ 10:37 AM
NCT ID:
NCT02810028
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosed with one of four specific muscle diseases on the basis of diagnostic criteria:
1. Limb girdle muscular dystrophy; symptomatic limb girdle muscular dystrophy genetically or pathologically proven
2. Dystrophinopathies resulting in a Becker' muscular dystrophy phenotype (excluding Duchenne muscular dystrophy) with pathology or genetic diagnosis
3. Facioscapulohumeral muscular dystrophy diagnosed clinically with specific genetic abnormality in the subject or their family
4. Inclusion body myositis clinic-pathologically defined, clinically defined or probable IBM based on ENMC research diagnostic criteria 2013 (submitted)
2. duration of muscle disease greater than six months
3. over the age of 18 years
4. access to the internet and a computer on which they can receive the intervention materials
5. HADS scores \> 8 for depression or \>8 for anxiety
Exclusion Criteria:
1. Major active co-morbidities unrelated to muscle disease such as arthritis, respiratory disease, cardiovascular disease
2. Unstable complications of muscle disease including:
1. neuromuscular respiratory weakness
2. cardiomyopathy
3. Cognitive impairment that prevents comprehension of the questionnaires; assessed using the Montreal Cognitive Assessment
4. Unable to read English questionnaires
5. Major diagnosed active mental health co-morbidities e.g. psychosis, major depression, obsessive compulsive disorder, active suicide risk
6. Current or recent participation in other treatment intervention studies (\< 4 weeks after completion)
7. Currently receiving psychological support or psychotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02810028
Study Brief:
Protocol Section:
NCT02810028