Condition category
Mental and Behavioural Disorders
Date applied
12/09/2002
Date assigned
12/09/2002
Last edited
09/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

20/09/1999

Overall trial end date

31/07/2004

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17403972

Publication citations

  1. Results

    Schmidt U, Lee S, Beecham J, Perkins S, Treasure J, Yi I, Winn S, Robinson P, Murphy R, Keville S, Johnson-Sabine E, Jenkins M, Frost S, Dodge L, Berelowitz M, Eisler I, A randomized controlled trial of family therapy and cognitive behavior therapy guided self-care for adolescents with bulimia nervosa and related disorders., Am J Psychiatry, 2007, 164, 4, 591-598, doi: 10.1176/appi.ajp.164.4.591.

Additional files

Editorial Notes