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Table 2 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) trial schedule

From: Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial

  1. *Primary outcome; †key secondary outcomes; Δother secondary outcomes
  2. BRAF-MDQ Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, BRAF-NRS Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale, CBT-i cognitive behavioural therapy for insomnia, CRP C-reactive protein, DAS28 Disease Activity Score-28, HADS-D Hospital Anxiety and Depression Scale-Depression, HRQoL health-related quality of life, ISI Insomnia Severity Index, MDHAQ Multidimensional Health Assessment Questionnaire, PSG polysomnography, PSQI Pittsburgh Sleep Quality Index, RA rheumatoid arthritis, RAID Rheumatoid Arthritis Impact of Disease, SE sleep efficiency, SF-36 Short Form-36 health survey, SOL sleep-onset latency, TST total sleep time, VAS visual analogue scale, WASO wake after sleep onset