Contact information
Type
Scientific
Contact name
Dr Ulrike Schmidt
ORCID ID
Contact details
Eating Disorder Research Unit
Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7919 3180/7848 0181
ulrike.schmidt@slam-tr.nhs.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
1206/88
Study information
Scientific title
Acronym
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.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
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
Reason abandoned (if study stopped)
Eligibility
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 type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
42 per group; 84 in total
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
Sponsor information
Organisation
The Health Foundation (UK)
Sponsor details
90 Long Acre
London
WC2E 9RA
United Kingdom
+44 (0)20 7257 8000
info@health.org.uk
Sponsor type
Charity
Website
http://www.pppfoundation.org.uk/
ROR
Funders
Funder type
Charity
Funder name
The Health Foundation
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/04/2007 | Yes | No |