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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list