| Source of record | UK Trials |
| ISRCTN | ISRCTN70120585 |
| Date ISRCTN assigned | 12/09/2002 |
| Local reference number(s) | 1206/88 |
| Public title | A randomized controlled evaluation of the cost effectiveness of cognitive-behavioural guided self-care versus family therapy for adolescent bulimia nervosa in a catchment area-based population |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Bulimia nervosa |
| Study hypothesis | 1. In adolescents with bulimia nervosa or eating disorder not otherwise specified (EDNOS), family therapy (FT) will produce higher rates of abstinence from bingeing and vomiting, both post-treatment (6 months) and at follow-up (12 months) than individual cognitive behavioural guided self-care (CBT-GSC).
2. CBT-GSC will be less costly to implement than FT. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Institute of Psychiatry Research and South London and Maudsley NHS Trust Research Ethics Committee. Date of approval 17/09/1999, reference number 163/99. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Aged 20 years or under, referred to one of the following study centres: Maudsley Eating Disorders Services, Surrey-Hampshire Borders Child and Adolescent Eating Disorders Services, Royal Free Eating Disorders Services, Phoenix Eating Disorders Service at St Ann's Hospital
2. Fulfil criteria for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) bulimia nervosa or eating disorders not otherwise specified |
| Participants - exclusion criteria | 1. A body mass index below the 10th centile for age and sex
2. Insufficient knowledge of English to understand the treatment manual
3. Learning disability, severe mental illness or alcohol/substance dependence |
| Patient information material |
|
| Anticipated start date | 20/09/1999 |
| Anticipated end date | 31/07/2004 |
| Status of trial | Completed |
| Target number of participants | 42 per group; 84 in total |
| Interventions | Patients randomly assigned to one of two groups: family therapy or guided-self care.
1. Family Therapy: 15 conjoint family therapy sessions over 6 months
2. Guided-self Care: 10 individual weekly sessions, up to two additional sessions with a close other, then three follow-up sessions over the next 3 months |
| Primary outcome measure(s) | Abstinence rates from binging and vomiting over the previous month, assessed at 6 and 12 months on an observer-rated interview measure. |
| Secondary outcome measure(s) | 1. Abstinence rates from bingeing and vomiting over the previous month, assessed at 6 and 12 months on a questionnaire measure
2. Longitudinal assessment of bingeing and vomiting by interview
3. Other eating disorder symptoms
4. Cost of care |
| Publications | Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17403972 |
| Sources of funding | The Health Foundation |
| Sponsor name | The Health Foundation (UK) |
| Sponsor details | 90 Long Acre
London
United Kingdom
WC2E 9RA |
| Sponsor telephone | +44 (0)20 7257 8000 |
| Sponsor fax | +44 (0)20 7257 8001 |
| Sponsor email | info@health.org.uk |
| Sponsor website | http://www.pppfoundation.org.uk/ |
| Contact name | Dr Ulrike Schmidt |
| Contact details | Eating Disorder Research Unit
Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
London
United Kingdom
SE5 8AF |
| Contact telephone | +44 (0)20 7919 3180/7848 0181 |
| Contact fax | +44 (0)20 7919 2358/7848 0182 |
| Contact email | ulrike.schmidt@slam-tr.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN70120585 |
| Date last extracted from ISRCTN register | 17/04/2008 |
