Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 97/41/08
Study information
Scientific title
Acronym
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Symptoms and general pathology: Other symptoms and general pathology
Intervention
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).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
Not provided at time of registration
Overall trial start date
01/08/2000
Overall trial end date
31/01/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients suffering chronic fatigue syndrome
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
153
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2000
Recruitment end date
31/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Psychology (Health Specialty)
Bristol
BS16 1LE
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (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
HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/17014748
Publication citations
-
HTA monograph
O'Dowd H, Gladwell P, Rogers CA, Hollinghurst S, Gregory A, Cognitive behavioural therapy in chronic fatigue syndrome: a randomised controlled trial of an outpatient group programme., Health Technol Assess, 2006, 10, 37, iii-iv, ix-x, 1-121.