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 and Pollock, J 2015, 'Protocol for a randomised controlled trial for Reducing Arthritis Fatigue by clinical teams using cognitive behavioural approaches (RAFT).' , BMJ Open, 5 , e009061.
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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.
|Uncontrolled Keywords:||Rheumatoid arthritis, Fatigue, Self-management, Cognitive-behavioural therapy|
|Themes:||Health and Wellbeing|
|Schools:||Schools > School of Health Sciences > Centre for Health Sciences Research|
|Journal or Publication Title:||BMJ Open|
|Funders:||NIHR HTA programme|
|Depositing User:||Professor Alison Hammond|
|Date Deposited:||13 Oct 2015 11:08|
|Last Modified:||30 Nov 2015 09:08|
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