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Table 1 Inclusion and exclusion criteria of the non-inferiority trial

From: Testing non-inferiority of blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis and the effectiveness of blended booster sessions aimed at improving long-term outcome following both therapies: study protocol for two observer-blinded randomized clinical trials

Inclusion criteria

Exclusion criteria

a. Definitive diagnosis of MS confirmed by a neurologist

a. Depression (BDI >4 and meeting criteria of depression as assessed by MINI)

b. Severely fatigued (CIS20r fatigue ≥35)

b. Primary sleep disorders (anamnesis)

c. Age between 18 and 70

c. Severe co-morbidity (CIRS item ≥3)

d. Ambulatory patients (EDSS ≤6)

d. Current pregnancy or having given birth in the past 3 months

e. No evident signs of an exacerbation, or corticosteroid treatment in the past three months

e. Pharmacological treatment for fatigue that was started in the past 3 months

f. No current infections (anamnesis)

f. Non-pharmacological therapies for fatigue that took place in the last 3 months

g. No anaemia (anamnesis)

g. Receiving CBT in the TREFAMS-CBT trial

h. A normal thyroid function (anamnesis)

 
  1. Abbreviations: BDI Beck Depression Inventory, CBT cognitive behavioural therapy, CIRS Cumulative Illness Rating Scale, CIS20r Checklist Individual Strength, EDSS Expanded Disability Status Scale, MINI mini international neuropsychiatric interview, MS multiple sclerosis, TREFAMS TREating FAtigue in MS