Condition category
Nervous System Diseases
Date applied
08/03/2007
Date assigned
22/05/2007
Last edited
03/05/2011
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

Prof Trudie Chalder

ORCID ID

Contact details

Department of Psychological Medicine
King's College London
Weston Education Centre
Cutcombe Road
London
SE5 9RJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Cognitive Behaviour Therapy (CBT) will result in higher levels of school return than psycho-education at six months follow up.

Ethics approval

King's College London Hospital (UK) on the 14/09/1999 (ref: 99/247)

Study design

A randomised controlled trial in which 13 sessions of family focused CBT was compared to 4 sessions of psycho-education over six months.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic Fatigue Syndrome (CFS) otherwise known as Myalgic Encephalomyelitis (ME)

Intervention

13 sessions of family focused CBT versus four sessions of psycho-education over six months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

School attendance expressed as a percentage of what was expected.

Secondary outcome measures

As a secondary outcome school attendance was dichotomised with a good outcome set at 70% or more, as at this age many healthy adolescents are not attending school or college full time. The following were recorded at six months:
1. Fatigue: Chalder Fatigue Scale - internal consistency in this sample was excellent with a Chronbach’s alpha of 0.89
2. Functional impairment: physical functioning subscale of the 36-item Short Form health survey (SF-36) (range 0 to 100 higher scores denoting better health) - this measure is valid and reliable and has been used in adolescents with CFS
3. Degree to which fatigue interfered with adolescent’s life: Social Adjustment Scale - Chronbach’s alpha was 0.91
4. Emotional and social responses: adolescents and their mothers completed the strengths and difficulties questionnaire - this measure has been shown to be valid and reliable in a number of studies
5. Global improvement and satisfaction: Global Outcome Scales - an assessor, blind to the group in which participants were randomised, carried out a semi-structured interview with the adolescent and rated degree of improvement in fatigue and disability on a nine-point scale from “much better” to “much worse”

Overall trial start date

01/02/2000

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adolescents between 11and 18
2. Fulfill criteria for chronic fatigue syndrome
3. Have been investigated by a Paediatrician
4. If on anti-depressants, then had to be on a stable dose for three months

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

58 participants

Participant exclusion criteria

1. Major depression
2. Somatisation disorder
3. Conversion disorder
4. History of self harm
5. Identifiable disease

Recruitment start date

01/02/2000

Recruitment end date

30/06/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychological Medicine
London
SE5 9RJ
United Kingdom

Sponsor information

Organisation

South London & Maudsley NHS Trust (UK)

Sponsor details

Denmark Hill
London
SE5 8AZ
United Kingdom

Sponsor type

Government

Website

http://www.slam.nhs.uk/

Funders

Funder type

Government

Funder name

NHS Executive London Region Office (UK) (ref: RFG 640)

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19891804

Publication citations

  1. Results

    Chalder T, Deary V, Husain K, Walwyn R, Family-focused cognitive behaviour therapy versus psycho-education for chronic fatigue syndrome in 11- to 18-year-olds: a randomized controlled treatment trial., Psychol Med, 2010, 40, 8, 1269-1279, doi: 10.1017/S003329170999153X.

Additional files

Editorial Notes