Contact information
Type
Scientific
Primary contact
Dr Tom Sensky
ORCID ID
Contact details
Imperial College School of Medicine
West Middlesex University Hospital
Isleworth
TW7 6AF
United Kingdom
+44 (0)20 8565 2121
abc@123.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDC00038
Study information
Scientific title
An investigation of the efficacy of a cognitive behavioural treatment for patients with recent onset rheumatoid arthritis
Acronym
Study hypothesis
The present study will aim to investigate the efficacy of a cognitive behavioural intervention for patients with recent onset Rheumatoid Arthritis (RA). Research has clearly demonstrated that cognitive-behavioural treatments are successful in treating patients with RA, but much of the research to date has been with people with a long history of active disease. This is clinically important since earlier intervention might prevent psychologically and/or physical morbidity.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
Rheumatoid arthritis
Intervention
1. Individual course of cognitive-behavioural therapy
2. Matched waiting list control group
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Coping Strategies Questionnaire
2. Percentage of subjects with clinically important depression or anxiety
3. Proportion of subjects with Eryhtrocyte Sedimentation Rate (ESR) of more than 30 mm/hr
4. Proportion of subjects with C-Reactive Protein (CRP) of more than 10 mg/l
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/05/1995
Overall trial end date
30/09/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 40 patients recruited from the West Middlesex University Hospital Rheumatology Clinic
2. Age group 18-65
3. Definite or classic Rheumatoid Arthritis with onset of symptoms in the past two years
4. Active but stable on current medication
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
30/05/1995
Recruitment end date
30/09/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Imperial College School of Medicine
Isleworth
TW7 6AF
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (UK)
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
Basic results (scientific)
Publication list
1. 2001 initial results in http://www.ncbi.nlm.nih.gov/pubmed/11166484
2. 2003 long-term efficacy results in http://www.ncbi.nlm.nih.gov/pubmed/12626793
3. 2008 5-year follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/18311768
Publication citations
-
Initial results
Sharpe L, Sensky T, Timberlake N, Ryan B, Brewin CR, Allard S, A blind, randomized, controlled trial of cognitive-behavioural intervention for patients with recent onset rheumatoid arthritis: preventing psychological and physical morbidity., Pain, 2001, 89, 2-3, 275-283.
-
Sharpe L, Sensky T, Timberlake N, Ryan B, Allard S, Long-term efficacy of a cognitive behavioural treatment from a randomized controlled trial for patients recently diagnosed with rheumatoid arthritis., Rheumatology (Oxford), 2003, 42, 3, 435-441.
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Sharpe L, Allard S, Sensky T, Five-year followup of a cognitive-behavioral intervention for patients with recently-diagnosed rheumatoid arthritis: effects on health care utilization., Arthritis Rheum., 2008, 59, 3, 311-316, doi: 10.1002/art.23312.