Condition category
Mental and Behavioural Disorders
Date applied
03/07/2009
Date assigned
04/08/2009
Last edited
03/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.help4bulimia.co.uk

Contact information

Type

Scientific

Primary contact

Miss Carrie-Anne McClay

ORCID ID

Contact details

University of Glasgow
Section of Psychological Medicine
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
+44 (0)141 211 0646
c.mcclay@hotmail.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Can be found at http://www.help4bulimia.co.uk

Condition

Bulimia nervosa

Intervention

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

01/08/2009

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

01/08/2009

Recruitment end date

31/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Glasgow
Glasgow
G12 0XH
United Kingdom

Sponsor information

Organisation

University of Glasgow (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.gla.ac.uk/

Funders

Funder type

Charity

Funder name

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

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

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23502689

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