An investigation of the efficacy of a cognitive behavioural treatment for patients with recent onset rheumatoid arthritis

ISRCTN	ISRCTN98753115
DOI	https://doi.org/10.1186/ISRCTN98753115
Protocol serial number	RDC00038
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive London (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Tom Sensky
Scientific

Imperial College School of Medicine
West Middlesex University Hospital
Isleworth
TW7 6AF
United Kingdom

Phone	+44 (0)20 8565 2121
Email	abc@123.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	An investigation of the efficacy of a cognitive behavioural treatment for patients with recent onset rheumatoid arthritis
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Rheumatoid arthritis
Intervention	1. Individual course of cognitive-behavioural therapy 2. Matched waiting list control group
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2000

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	40
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	30/05/1995
Date of final enrolment	30/09/2000

Imperial College School of Medicine

Isleworth
TW7 6AF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	initial results	01/01/2001	Yes	No
Results article	long-term efficacy results	01/03/2003	Yes	No
Results article	5-year follow-up results	15/03/2008	Yes	No

05/07/2018: Internal review