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
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 design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 01/08/2000 |
| Completion date | 31/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Clinical Psychology (Health Specialty)
Bristol
BS16 1LE
United Kingdom
BS16 1LE
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
