Condition category
Signs and Symptoms
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
30/08/2012
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

Prof Peter Campion

ORCID ID

Contact details

Department of Public Health and Primary Care
University of Hull
College House
East Riding Campus
Willerby
HU10 6NS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSI06-16

Study information

Scientific title

Acronym

Study hypothesis

A pragmatic randomised controlled trial was conducted in general practice to test the hypotheses that general practitioners could (a) diagnose and (b) treat patients with the Chronic Fatigue Syndrome (CFS).

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

GP practices

Trial type

Other

Patient information sheet

Condition

Other symptoms and general pathology

Intervention

The intervention we attempted to introduce was a form of brief behavioural therapy, offered to GPs as a management package. Control practices were invited to manage their patients as usual, which in many cases included referral to secondary care.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The study suffered from both poor recruitment and high drop out. However, we were able to show that this intervention had no effect on the illness of the patients enrolled, and that patients with CFS remained highly disabled over the 12 month study period, whatever their treatment. The study suggests that general practitioners can diagnose CFS, but under the conditions of this study were unable to effectively treat the condition. This accords with the recent Royal Colleges' report, that early recognition in primary care is important, but that the only evidence for effective treatment thus far has come from specialist units. General practitioners do not yet generally have the skills nor the time to provide effective treatment programmes for CFS.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1995

Overall trial end date

01/02/1998

Reason abandoned

Eligibility

Participant inclusion criteria

General Practices willing to take part.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/1995

Recruitment end date

01/02/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Public Health and Primary Care
Willerby
HU10 6NS
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Primary and Secondary Care Interface National Research and Development Programme (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

Publication citations

Additional files

Editorial Notes