Condition category
Signs and Symptoms
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
26/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hazel O'Dowd

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/en/index.htm

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

  1. 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.

Additional files

Editorial Notes