title: Protocol for a randomised controlled trial for Reducing Arthritis Fatigue by clinical Teams (RAFT) using cognitive-behavioural approaches.
abstract: BACKGROUND
  Rheumatoid arthritis (RA) fatigue is distressing, leading to unmanageable physical and cognitive exhaustion impacting on health, leisure and work. Group cognitive-behavioural (CB) therapy delivered by a clinical psychologist demonstrated large improvements in fatigue impact. However, few rheumatology teams include a clinical psychologist, therefore, this study aims to examine whether conventional rheumatology teams can reproduce similar results, potentially widening intervention availability.
  
  
  METHODS
  This is a multicentre, randomised, controlled trial of a group CB intervention for RA fatigue self-management, delivered by local rheumatology clinical teams. 7 centres will each recruit 4 consecutive cohorts of 10-16 patients with RA (fatigue severity ≥ 6/10). After consenting, patients will have baseline assessments, then usual care (fatigue self-management booklet, discussed for 5-6 min), then be randomised into control (no action) or intervention arms. The intervention, Reducing Arthritis Fatigue by clinical Teams (RAFT) will be cofacilitated by two local rheumatology clinicians (eg, nurse/occupational therapist), who will have had brief training in CB approaches, a RAFT manual and materials, and delivered an observed practice course. Groups of 5-8 patients will attend 6 × 2 h sessions (weeks 1-6) and a 1 hr consolidation session (week 14) addressing different self-management topics and behaviours. The primary outcome is fatigue impact (26 weeks); secondary outcomes are fatigue severity, coping and multidimensional impact, quality of life, clinical and mood status (to week 104). Statistical and health economic analyses will follow a predetermined plan to establish whether the intervention is clinically and cost-effective. Effects of teaching CB skills to clinicians will be evaluated qualitatively.
  
  
  BACKGROUND
  Approval was given by an NHS Research Ethics Committee, and participants will provide written informed consent. The copyrighted RAFT package will be freely available. Findings will be submitted to the National Institute for Health and Care Excellence, Clinical Commissioning Groups and all UK rheumatology departments.
  
  
  BACKGROUND
  
  52709998; Protocol v3 09.02.2015.
authors.affiliation: Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.
authors.forename: S
authors.identifier: http://orcid.org/0000-0001-7851-2039
authors.initials: S
authors.lastname: Hewlett
authors.affiliation: Pain Management Centre, Southmead Hospital, Bristol, UK.
authors.forename: N
authors.initials: N
authors.lastname: Ambler
authors.affiliation: Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.
authors.forename: C
authors.initials: C
authors.lastname: Almeida
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: P S
authors.initials: PS
authors.lastname: Blair
authors.affiliation: Section of Rheumatology, Institute of Infection and Immunity, Cardiff University, Cardiff, UK.
authors.forename: E
authors.initials: E
authors.lastname: Choy
authors.affiliation: Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.
authors.forename: E
authors.initials: E
authors.lastname: Dures
authors.affiliation: Centre for Health Sciences Research, School of Health Sciences, University of Salford, Salford, UK.
authors.forename: A
authors.initials: A
authors.lastname: Hammond
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: W
authors.initials: W
authors.lastname: Hollingworth
authors.affiliation: Academic Rheumatology, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors.forename: J
authors.initials: J
authors.lastname: Kirwan
authors.affiliation: Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.
authors.forename: Z
authors.initials: Z
authors.lastname: Plummer
authors.affiliation: Patient research partner, Academic Rheumatology, Bristol Royal Infirmary, Bristol, UK.
authors.forename: C
authors.initials: C
authors.lastname: Rooke
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: J
authors.initials: J
authors.lastname: Thorn
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: K
authors.initials: K
authors.lastname: Tomkinson
authors.affiliation: Department of Health and Social Sciences, University of the West of England Bristol, Bristol, UK.
authors.forename: J
authors.initials: J
authors.lastname: Pollock
mesh_terms: D000223:Adaptation, Psychological; D000339:Affect; D001172:Arthritis, Rheumatoid / Q000150:complications* / Q000523:psychology; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods; D003362:Cost-Benefit Analysis; D005221:Fatigue / Q000209:etiology / Q000628:therapy*; D006801:Humans; D010348:Patient Care Team; D011788:Quality of Life; D012648:Self Care
keywords: RHEUMATOLOGY