Condition category
Musculoskeletal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
15/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDC00038

Study information

Scientific title

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

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 five-year follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/18311768

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes