Contact information
Type
Scientific
Primary contact
Dr Sarah Hewlett
ORCID ID
Contact details
Academic Rheumatology
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 2903
Sarah.Hewlett@uwe.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Rheumatoid arthritis, an autoimmune disease causing synovitis in multiple small joints. It has varying levels of inflammatory activity that progressively lead to joint destruction, disability, fatigue, pain and potential psychological sequalae. Self-management is key, but fatigue is rarely addressed and patients rate it as important and overwhelming, but do not know how to manage it.
Aim 1: To test the null hypothesis that there will be no difference in change in the impact of fatigue, between Rheumatoid Arthritis (RA) patients participating in a multi-disciplinary, Cognitive Behavioural Therapy (CBT)-based fatigue self-management programme, compared to those receiving standard information alone
Aim 2: To explore the contribution of the different components of the complex multi-disciplinary CBT package
Ethics approval
Approval received from the North Somerset and South Bristol REC on the 11th January 2007 (ref: 06/Q2006/149).
Study design
Aim 1: Non-blinded, randomised controlled intervention study, with analysis blind to group allocation
Aim 2: Nested qualitative study within the complex intervention arm
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Rheumatoid arthritis
Intervention
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 by a nurse, physiotherapist, Occupational Therapist and psychology research associate.
Three to four facilitators will attend all sessions to ensure quality CBT and team working, to allow one-to-one goal setting and to ensure patients can receive adequate individual support if issues are discussed that have particular personal implications for them (e.g., effect of fatigue on relationships). Sessions will be supported with handouts, and some work at home in between the weekly sessions is a necessary part of the course, e.g., diary keeping and achieving goals.
The first session will establish:
1. The groups ground rules (e.g., commitment and confidentiality)
2. The purpose and expectations of the course (e.g., management not cure)
3. Defining fatigue and its consequences
4. Differentiating between disease activity flares, pain, stiffness and fatigue
Goal-setting will be introduced in the second session and will form a feature of every session.
Sessions two to six will cover:
1. Energy management (planning, pacing and prioritising activities)
2. Activity cycling
3. Assertiveness
4. Recuperation or restoration of energy
5. Sleep
6. Negative self-talk
7. Graded activity
8. Passivity
9. Reconditioning and increasing physical activity
10. Links between fatigue, pain, stress, and depression
11. Relaxation
12. Management of stress
13. Avoiding and resolving setbacks
Using the theoretical concepts of CBT, enhancing self-efficacy and achieving behaviour change, the course will use delivery methods such as role modelling, group work, addressing barriers, and positive reinforcements (e.g., using a pedometer as a visual aid to increase activity). Patients will be asked to keep a diary of events in order to help them manage their fatigue more effectively. Individually tailored goal-setting and contracting will be used to set individual, realistic goals, which are the means of transferring gains in managing the RA symptoms, into improved quality of life. The aim is that participants will achieve improved functioning in their domestic role and social life, which should in turn raise confidence and reduce emotional distress, including depression.
The information-only arm will involve a single, one-hour group session of seven to ten participants, led by a rheumatology nurse (DP). It will use a largely information-giving approach, based on the two arc leaflets, allowing participants to share and discuss their current experiences and coping mechanisms. The clinical psychologist (NA) will provide support for the researcher before she delivers the control arm sessions (DP), to ensure a CBT approach is not utilised. The approach taken in the control arm will be to provide information and support the current coping strategies the participants already use, as it is not known whether or not a CBT approach is beneficial.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 outcome measures
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.
Overall trial start date
01/01/2007
Overall trial end date
01/09/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
n=88, ie 44 completed data sets per arm
Participant 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).
Recruitment start date
01/01/2007
Recruitment end date
01/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Rheumatology
Bristol
BS2 8HW
United Kingdom
Sponsor information
Organisation
University of the West of England (UK)
Sponsor details
c/o Professor Robin Means
Associate Dean
Faculty of Health and Social Care
Glenside Campus
Blackberry Hill
Bristol
BS16 1DD
United Kingdom
Robin.Means@uwe.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign (UK) (grant)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21540202
Publication citations
-
Results
Hewlett S, Ambler N, Almeida C, Cliss A, Hammond A, Kitchen K, Knops B, Pope D, Spears M, Swinkels A, Pollock J, Self-management of fatigue in rheumatoid arthritis: a randomised controlled trial of group cognitive-behavioural therapy., Ann. Rheum. Dis., 2011, 70, 6, 1060-1067, doi: 10.1136/ard.2010.144691.