Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis
Conditions
Interventions
The CBT intervention programme will be delivered weekly over six weeks, to groups of seven to ten patients, in sessions lasting two hours. The course will be led by a clinical psychologist, supported
Sponsors
University of the West of England (UK)
Eligibility
Inclusion criteria
Inclusion criteria: Aim 1: Patients will have a diagnosis of RA, and a score of more than seven for fatigue during the past week (Visual Analogue Scale [VAS] zero to ten) Aim 2: Patients attending the intervention arm, purposive sampling for wide range of variables
Exclusion criteria
Exclusion criteria: Patients will be excluded if they have had a change in drugs likely to alter fatigue just prior to recruitment (within four months for Disease Modifying Anti-Rheumatic Drugs, within six weeks for intramuscular [i/m] glucocorticoids).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is change in fatigue impact and will be measured using the Multi-Dimensional Aspects of Fatigue scale (an RA-specific scale). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes are: 1. Perceived ability to cope with fatigue, which will be measured with a Visual Analogue Score (VAS) 2. Perceived fatigue severity (VAS) and physical status, which includes pain (VAS), disability (Health Assessment Questionnaire), and sleep (selected question from the Pittsburgh Sleep Quality Index) 3. Mood will be measured using the Hospital Anxiety and Depression Scale, and the Arthritis Helplessness Index 4. Quality of life will be measured using the RA Quality of Life Scale, a simple VAS for the personal impacts of fatigue (impact VAS) and disability (Personal Impact HAQ) The variables will be measured at all time-points (one, six, ten and 18 weeks). Process measures include number of sessions attended and self-efficacy (RA Self-Efficacy Scale), measured at all time-points. | — |
Countries
United Kingdom
Outcome results
None listed