Cognitive behavioural therapy (CBT) in Chronic Fatigue Syndrome (CFS): A randomised controlled trial of an outpatient group programme

ISRCTN ISRCTN37461058
DOI https://doi.org/10.1186/ISRCTN37461058
Secondary identifying numbers HTA 97/41/08
Submission date
25/04/2003
Registration date
25/04/2003
Last edited
08/11/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hazel O'Dowd
Scientific

Clinical Psychology (Health Specialty)
North Bristol NHS Trust
Pain Management Centre
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleCognitive behavioural therapy (CBT) in Chronic Fatigue Syndrome (CFS): A randomised controlled trial of an outpatient group programme
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSymptoms and general pathology: Other symptoms and general pathology
Intervention1. 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 typeOther
Primary outcome measureConventional 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 measuresNot provided at time of registration
Overall study start date01/08/2000
Completion date31/01/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants153
Key inclusion criteriaPatients suffering chronic fatigue syndrome
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/08/2000
Date of final enrolment31/01/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Clinical Psychology (Health Specialty)
Bristol
BS16 1LE
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article HTA monograph 01/10/2006 Yes No

Editorial Notes

08/11/2022: Internal review.