Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
03/03/2011
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

Dr Trudie Chalder

ORCID ID

Contact details

King's College School of Medicine
103 Denmark Hill
London
SE5 8AZ
United Kingdom
+44 (0)20 7740 5078
trudie.chalder@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDC01636

Study information

Scientific title

Acronym

Study hypothesis

The study members have developed a family oriented cognitive behavioural approach for adolescents with chronic fatigue syndrome (CFS). The approach is based on a model of understanding the condition which makes a distinction between precipitating and perpetuating factors. The model will be tested via a randomised controlled trial.

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

Treatment

Patient information sheet

Condition

Chronic fatigue syndrome

Intervention

i. Family focused cognitive behavioural psychotherapy (CBT)
ii. Treatment as usual (TAU)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The main outcome will be the school attendance rate expressed as a percentage of expected attendance.

Secondary outcome measures

Anxiety and depression

Overall trial start date

01/10/1999

Overall trial end date

01/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged between 11 and 17 years fulfilling the criteria for CFS.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/1999

Recruitment end date

01/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College School of Medicine
London
SE5 8AZ
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London, 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

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