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
| ISRCTN | ISRCTN70120585 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70120585 |
| Secondary identifying numbers | 1206/88 |
- Submission date
- 12/09/2002
- Registration date
- 12/09/2002
- Last edited
- 09/05/2007
- 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
Dr Ulrike Schmidt
Scientific
Scientific
Eating Disorder Research Unit
Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7919 3180/7848 0181 |
|---|---|
| ulrike.schmidt@slam-tr.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| 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. |
| Ethics approval(s) | Institute of Psychiatry Research and South London and Maudsley NHS Trust Research Ethics Committee. Date of approval 17/09/1999, reference number 163/99. |
| Condition | Bulimia nervosa |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | Abstinence rates from binging and vomiting over the previous month, assessed at 6 and 12 months on an observer-rated interview measure. |
| Secondary outcome measures | 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 |
| Overall study start date | 20/09/1999 |
| Overall study end date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 42 per group; 84 in total |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 20/09/1999 |
| Recruitment end date | 31/07/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Eating Disorder Research Unit
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
The Health Foundation (UK)
Charity
Charity
90 Long Acre
London
WC2E 9RA
United Kingdom
| Phone | +44 (0)20 7257 8000 |
|---|---|
| info@health.org.uk | |
| Website | http://www.pppfoundation.org.uk/ |
"ROR" |
https://ror.org/02bzj4420 |
Funders
Funder type
Charity
The Health Foundation
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 | 01/04/2007 | Yes | No |
