Clinical trial: Acceptance and Commitment Therapy for Muscle Disease (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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD.

Patient description (patient's own words): I brought my  8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy.

Does the patient match the trial criteria? Contradiction