|
ISRCTN
|
ISRCTN07388346
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Internet-based CBT self-help treatment for students with bulimia nervosa
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0042166634
|
|
Study hypothesis
|
Does internet-based Cognitive Behavioural Therapy improve symptoms for students with Bulimia Nervosa more than a self-help manual?
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Mental and Behavioural Disorders: Bulimia nervosa
|
|
Participants - inclusion criteria
|
The sample will be recruited by e-mails to the entire student population of King's College London and consist of students with a diagnosis of BN or EDNOS, who fulfill our inclusion criteria:
1. DSM IV criteria for bulimia or eating disorders not otherwise specified (EDNOS) with bingeing
2. Student (any age or sex)
3. Body Mass Index of 18.5 or greater anorexia
|
|
Participants - exclusion criteria
|
1. Insufficient knowledge of English to follow computerised programme
2. Anorexia nervosa, psychotic symptoms, servere depression, suicidal thinking or major self harm risk
3. Substance dependency
4. Pregnancy
5. Serious physical illness
6. Regular vomiting greater than 4 times in 24 hourse on a regular basis if a subsequent blood test reveals hypokalaemia
7. Current or recent CBT
8. Plans to change medication in the coming 3 months
|
|
Anticipated start date
|
01/08/2005
|
|
Anticipated end date
|
31/07/2007
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
100
|
|
Interventions
|
This is a preliminary RCT.
The intervention group will receive a package of CBT by the internet over 8-12 weeks, with the support of an internet bulletin board and weekly e-mail exchange with a clinician.
The control group will receive a self-help manual for BN without any additional support.
|
|
Primary outcome measure(s)
|
1. Eating Disorders Examination (EDE)
2. WHO Quality of Life measure - brief version (WHOQOL-bref)
3. Qualitative questionnaire along with semi-structured qualitative interviews
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
South London and Maudsley NHS Trust (UK), NHS R&D Support Funding
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Ulrike
Schmidt
|
|
Address
|
Eating Disorders Unit
Maudsley Hospital
South London & Maudsley Trust
Denmark Hill
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE5 8AZ
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7848 0181
|
|
Fax
|
+44 (0)20 7848 0182
|
|
Email
|
u.schmidt@iop.kcl.ac.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
29/09/2006
|
|
Last edited
|
29/10/2010
|
|
Date ISRCTN assigned
|
29/09/2006
|
