Will an online life skills package be helpful for individuals with bulimia nervosa?
| ISRCTN | ISRCTN41034162 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41034162 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/07/2009
- Registration date
- 04/08/2009
- Last edited
- 03/04/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Miss Carrie-Anne McClay
Scientific
Scientific
University of Glasgow
Section of Psychological Medicine
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
| Phone | +44 (0)141 211 0646 |
|---|---|
| c.mcclay@hotmail.co.uk |
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Can be found at http://www.help4bulimia.co.uk |
| 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(s) | University of Glasgow Medical Faculty Ethics Committee approved on the 27th May 2009 (ref: FM03508) |
| 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 |
| 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 study start date | 01/08/2009 |
| Overall study end date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 250 participants |
| 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 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
- Scotland
- United Kingdom
Study participating centre
University of Glasgow
Glasgow
G12 0XH
United Kingdom
G12 0XH
United Kingdom
Sponsor information
University of Glasgow (UK)
University/education
University/education
Finance and Purchasing Office
Gilbert Scott Building
Glasgow
G12 8QQ
Scotland
United Kingdom
| Website | http://www.gla.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/00vtgdb53 |
Funders
Funder type
Charity
Helen Hay Pollock Bequest (UK) (ref: 48261)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/03/2013 | Yes | No |
