|
ISRCTN
|
ISRCTN37461058
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Cognitive behavioural therapy (CBT) in Chronic Fatigue Syndrome (CFS): A randomised controlled trial of an outpatient group programme
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
HTA 97/41/08
|
|
Study hypothesis
|
To test the hypothesis that group CBT will produce an effective and efficient management strategy for patients in primary care with Chronic Fatigue Syndrome.
Please note that, as of 14 January 2008, the anticipated start and end dates of this trial have been updated from 1 July 1999 and 31 December 2002 to 1 August 2000 and 31 January 2004, respectively.
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Symptoms and general pathology: Other symptoms and general pathology
|
|
Participants - inclusion criteria
|
Patients suffering chronic fatigue syndrome
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/08/2000
|
|
Anticipated end date
|
31/01/2004
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
153
|
|
Interventions
|
1. CBT
2. Support/Education (control for non-specific group factors)
3. Standard Medical Care
Assessment: pretreatment, 6 months, 1 year follow-up.
Setting: Consecutive referrals from primary care and secondary outpatient clinic (this combines services from 2 NHS Trusts).
|
|
Primary outcome measure(s)
|
Conventional standardised outcome measures will be used.
Within this the main measures include SF36, Physical Function Measure (STET), HADS, CFS Neurocognitive battery and the Fatigue Scale. The study will compare both the outcomes and costs. Relevant resource use includes not only the direct costs of the interventions, but also the costs of managing the symptoms of CFS.
The cost benefit analysis will adopt specific outcome criteria for functional performance and emotional distress to derive the number needed to treat (NNT) ratio in order to compare the three groups. Assumptions and uncertainties in either resource use or outcome will be tested using sensitivity analysis.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
NIHR Health Technology Assessment Programme - HTA (UK)
|
|
Trial website
|
|
|
Publications
|
HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/17014748
|
|
Contact name
|
Dr
Hazel
O'Dowd
|
|
Address
|
Clinical Psychology (Health Specialty)
North Bristol NHS Trust
Pain Management Centre
Frenchay Hospital
Frenchay Park Road
|
|
City/town
|
Bristol
|
|
Zip/Postcode
|
BS16 1LE
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Department of Health (UK)
|
|
Address
|
Quarry House
Quarry Hill
|
|
City/town
|
Leeds
|
|
Zip/Postcode
|
LS2 7UE
|
|
Country
|
United Kingdom
|
|
Email
|
Sheila.Greener@doh.gsi.gov.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/en/index.htm
|
|
Date applied
|
25/04/2003
|
|
Last edited
|
26/08/2009
|
|
Date ISRCTN assigned
|
25/04/2003
|
