Plain English Summary
Background and study aims
Bulimia nervosa (BN) is an eating disorder that causes significant impairment and distress among sufferers. Cognitive-behavioural therapy (CBT) is the treatment of choice and early access to therapy seems to improve outcomes. However, most young people with eating disorders do not access effective treatment and in many areas, the availability of CBT is limited. The main aim of this study was to evaluate how well internet-based cognitive-behavioural therapy (iCBT), supplemented with e-mail support, works among students with BN or similar disorders. The secondary aim of the study was to evaluate how immediate delivery of iCBT compares to delaying this. This was done to introduce similar conditions to those that patients in the National Health Service (NHS) experience.
Who can participate?
For this study we recruited students of any age and gender that were studying at five London-based universities that were invited to take part in the study.
What does the study involve?
Participants were assessed and then allocated at random to two groups. One group received immediate iCBT and the other group was put on a waiting list to receive the same treatment. We compared the outcomes of people in the groups at two points. The first comparison was made after the first group received treatment and the second group had been on the waiting list for the same time (three months). The second comparison was done after the second group (the waiting list group) had completed the treatment; this time we compared the outcomes of the two groups once both had completed the treatment. All participants received the same treatment except that some received it immediately and others waited for three months to receive this.
What are the possible benefits and risks of participating?
Participants who enrolled in the study received access to an innovative form of treatment (iCBT). Many participants had not received any form of treatment previous to their involvement in the study. There were no side effects expected from this treatment. However, it was expected that people in the waiting list were not going to experience a rapid improvement because they were not receiving treatment.
Where is the study run from?
We recruited students from five universities based in London: Kings College London, The University of the Arts, Goldsmiths University, St Georges University and Laban.
When is the study starting and how long is it expected to run for?
The study lasted for three years and it was run between September 2005 and September 2008.
Who is funding the study?
South London and Maudsley NHS Foundation Trust, CONACyT (Consejo Nacional de Ciencia y Tecnología) and the National Institute for Health Research Biomedical Research Centre.
Who is the main contact?
Professor Ulrike Schmidt
ulrike.schmidt@kcl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ulrike Schmidt
ORCID ID
Contact details
Eating Disorders Unit
Maudsley Hospital
South London & Maudsley Trust
Denmark Hill
London
SE5 8AZ
United Kingdom
+44 (0)20 7848 0181
u.schmidt@iop.kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0042166634
Study information
Scientific title
Acronym
Study hypothesis
Current hypothesis as of 18/12/2013:
The main hypothesis was that people who received internet Cognitive Behavioural Therapy (iCBT) would have better outcomes than those on the waiting list. The secondary hypothesis was that people who received delayed iCBT would have poorer uptake of treatment and poorer outcomes compared to those who received immediate access to the treatment.
Previous hypothesis:
Does internet-based Cognitive Behavioural Therapy improve symptoms for students with Bulimia Nervosa more than a self-help manual?
Updated 18/12/2013: the anticipated start date was changed from 01/08/2005 to 01/09/2005 and the anticipated end date was changed from 31/07/2007 to 01/09/2008.
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
Mental and Behavioural Disorders: Bulimia nervosa
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
Not provided at time of registration
Overall trial start date
01/09/2005
Overall trial end date
01/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
100
Participant 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
Recruitment start date
01/09/2005
Recruitment end date
01/09/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Eating Disorders Unit
London
SE5 8AZ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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
South London and Maudsley NHS Trust (UK), NHS R&D Support Funding
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
Basic results (scientific)
Publication list
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/20406523
Publication citations
-
Results
Sánchez-Ortiz VC, Munro C, Stahl D, House J, Startup H, Treasure J, Williams C, Schmidt U, A randomized controlled trial of internet-based cognitive-behavioural therapy for bulimia nervosa or related disorders in a student population., Psychol Med, 2011, 41, 2, 407-417, doi: 10.1017/S0033291710000711.