Protocol for a randomised controlled trial for Reducing Arthritis Fatigue by clinical teams using cognitive behavioural approaches (RAFT).

Hewlett, S; Ambler, N; Almeida, C; Blair, PS; Choy, E; Dures, E; Hammond, A; Hollingworth, W; Kirwan, J; Plummer, Z; Rooke, C; Thorn, J; Tomkinson, K; Pollock, J

Abstract

Introduction: 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 and analysis: 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 costeffective.
Effects of teaching CB skills to clinicians will
be evaluated qualitatively.

• Journal Article Type: Article
• Acceptance Date: Jul 3, 2015
• Online Publication Date: Aug 6, 2015
• Publication Date: Aug 6, 2015
• Deposit Date: Oct 13, 2015
• Publicly Available Date: Apr 5, 2016
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 5
• Pages: e009061
• DOI: https://doi.org/10.1136/bmjopen-2015-009061
• Keywords: Rheumatoid arthritis, Fatigue, Self-management, Cognitive-behavioural therapy
• Publisher URL: http://dx.doi.org/10.1136/bmjopen-2015-009061
• Related Public URLs: http://bmjopen.bmj.com/content/5/8/e009061.full?sid=46e4612c-81b1-4cd6-a8c6-40a7332339bf