Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Sarah Hewlett


Contact details

Academic Rheumatology
Bristol Royal Infirmary
United Kingdom
+44 (0)117 928 2903

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Rheumatoid arthritis


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 group’s 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



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


Overall trial end date


Reason abandoned


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


Age group

Not Specified


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Academic Rheumatology
United Kingdom

Sponsor information


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
BS16 1DD
United Kingdom

Sponsor type




Funder type


Funder name

Arthritis Research Campaign (UK) (grant)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

  1. 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.

Additional files

Editorial Notes