Condition category
Mental and Behavioural Disorders
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
18/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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: King’s 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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/20406523

Publication citations

  1. 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.

Additional files

Editorial Notes