Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Miss Carrie-Anne McClay


Contact details

University of Glasgow
Section of Psychological Medicine
Gartnavel Royal Hospital
1055 Great Western Road
G12 0XH
United Kingdom
+44 (0)141 211 0646

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised controlled trial of an online life skills package for bulimia nervosa, recruiting from community settings


Study hypothesis

1. The immediate treatment group at 10 weeks:
1.1. Will have reduced bulimic symptoms compared to their baseline scores and controls
1.2. Will have reduced anxiety and depression scores along with increased social functioning compared to their baseline scores and controls
2. Both the immediate treatment group and delayed treatment group will show a reduction in bulimic symptoms, anxiety and depression scores and will have increased social functioning following completion of the package (however the delayed treatment group may exhibit lower levels of improvement)
3. Participants who complete more sessions of the package will show the highest levels of improvement in outcome measures. Therefore, we expect to see a dose-effect relationship.
4. Improvements in bulimic symptoms and other aspects of mental health and well being will be maintained at the 6 month follow-up due to the reusable nature of the package
5. The greatest improvements in condition will be seen in participants who have mild to moderate bulimic symptoms at baseline
6. Participants whose onset of bulimia is the most recent are expected to have the greatest improvements in outcome measures
7. We aim to ascertain who benefits most from using the package, i.e., mild to moderate sufferers or severe bulimics. Also whether onset of illness has an effect on the effectiveness of the package.

Ethics approval

University of Glasgow Medical Faculty Ethics Committee approved on the 27th May 2009 (ref: FM03508)

Study design

Single-centre randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Can be found at


Bulimia nervosa


Package name: 'Overcoming Bulimia Online'
Intervention: immediate access (IA) to the above package
Control: delayed access (DAC) to the above package after 10 weeks

Following entry into the randomised controlled trial (RCT) section of the study, participants will be randomly allocated to either the IA group or the DAC group. The IA group will be offered access to 'Overcoming Bulimia Online' following completion of baseline measures. The DAC group will be offered access to the package after a 10 week delay. Participants are advised to complete one session of the package per week so the package should take 8 - 19 weeks to complete. Participants will complete outcome measures at baseline, 10 weeks, 6 months, 12 months, with consent being taken to allow for future follow up assessment at 24 months and up to 10 years post-intervention (if future funding allowed a further follow-up contact).

Intervention type



Not Applicable

Drug names

Primary outcome measure

Eating Disorders Examination Questionnaire at baseline, 10 weeks, 6 months and 12 months. Main factors are:
1. Global score
2. Frequency or bingeing
3. Frequency of vomiting

Secondary outcome measures

1. Hospital anxiety and depression scale (HADS)
2. Work and Social Adjustment Scale
3. Recovery Locus of Control Scale
1. Hospital anxiety and depression scale (HADS), measured at baseline, 10 weeks, 6 months and 12 months
2. Work and Social Adjustment Scale, measured at baseline, 10 week and 12 months
3. Recovery Locus of Control Scale, measured at baseline, 10 week and 12 months
4. Significant Others Scale, measured at baseline
5. Mental Health Literacy Questionnaire, measured at baseline, 10 weeks, 6 months and 12 months
6. Economic analysis, measured at baseline, 10 weeks, 6 months and 12 months

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Stage One:
1. Aged 16 or above, either sex
2. Based in the UK
3. Show significant symptoms of bulimia nervosa or eating disorders not otherwise specified (EDNOS), as indicated by the Eating Disorder Examination Questionnaire
4. Body mass index (BMI) of 18.5 kg/m^2 or above

Stage Two:
1. Meet the criteria for a research diagnosis of bulimia EDNOS, as indicated by the Eating Disorders Examination Interview

Participant type


Age group




Target number of participants

250 participants

Participant exclusion criteria

Stage One:
1. Under the age of 16
2. Do not fulfil the inclusion criteria of Stage One

Both Stages:
1. Currently receiving specialist mental health therapy
2. Currently involved in any treatment based eating disorder research
3. Alcohol or drug dependent
4. Have active suicidal thoughts
5. Participate in severe self-harm
6. Have a diagnosis of psychosis
7. Diabetic
8. Pregnant

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Glasgow
G12 0XH
United Kingdom

Sponsor information


University of Glasgow (UK)

Sponsor details

Finance and Purchasing Office
Gilbert Scott Building
G12 8QQ
United Kingdom

Sponsor type




Funder type


Funder name

Helen Hay Pollock Bequest (UK) (ref: 48261)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

1. 2013 results in

Publication citations

  1. Results

    McClay CA, Waters L, McHale C, Schmidt U, Williams C, Online cognitive behavioral therapy for bulimic type disorders, delivered in the community by a nonclinician: qualitative study., J. Med. Internet Res., 2013, 15, 3, e46, doi: 10.2196/jmir.2083.

Additional files

Editorial Notes