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
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
-
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.