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
Protocol serial number	HTA 97/41/08
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Cognitive behavioural therapy (CBT) in Chronic Fatigue Syndrome (CFS): A randomised controlled trial of an outpatient group programme
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/01/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	153
Key inclusion criteria	Patients suffering chronic fatigue syndrome
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2000
Date of final enrolment	31/01/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Clinical Psychology (Health Specialty)

Bristol
BS16 1LE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not 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.