Contact information
Type
Scientific
Primary contact
Dr Ulrike Schmidt
ORCID ID
Contact details
Section of Eating Disorders
Box 059
Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0181
U.Schmidt@iop.kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LREC 217/00
Study information
Scientific title
Acronym
Study hypothesis
Hypothesis 1:
Patients receiving the CD-ROM treatment as the first step in treatment will show greater symptomatic improvement compared to patients on the waiting list at 3 months, and at 7 months patients in both groups will have similar outcomes.
Hypothesis 2:
Patients in the CD-ROM group will need fewer therapist sessions than those who do not have the CD-ROM as the first step of treatment.
Ethics approval
Received from the Institute of Psychiatry Research Ethics Committtee on the 17th October 2003 (ref: 217/00).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Bulimia nervosa
Intervention
ARM A:
CD-ROM self-care treatment: This treatment consists of eight modules, combining cognitive-behavioural, motivational and educational strategies which the patients work through in order. Each module requires about 45 minutes at the computer. Patient workbooks and homework accompany each session. Self-assessment tools in the programme provide patients with printed feedback on their progress, detailing levels of bulimic symptoms, depression and anxiety.
Patients in this group will access the treatment programme in the eating disorder unit. They will be introduced to the programme and booked in for further computer appointments by a non-clinical administrator.
Patients will be encouraged to complete the programme over eight to 12 weeks. Thereafter, the need for further treatment will be determined using operational criteria adapted from a recent study on manual-based self-help.
Those who have shown more than 50% improvement on both objective binging and vomiting/laxative abuse (whichever is the more important compensatory behaviour in their case) on the EDE (Eating Disorders Examination) will be offered up to five sessions with a therapist over the next three to four months. Those with less than 50% improvement on both objective binging and vomiting/laxative abuse (whichever is the more important compensatory behaviour in their case) on the EDE will be offered up to 15 sessions with a therapist over the next three to four months.
ARM B:
Waiting list followed by therapist-aided CBT (Cognitive-Behavioural Therapy):
Patients allocated to this group will have a three months wait before they start a full course of standard CBT (16 sessions). Patients in this group will not have access to the computer-based intervention at any stage.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Eating Disorders Examination Global Score
2. Frequencies of binges and vomiting over the previous 28 days
Secondary outcome measures
1. Eating Disorders Examination Subscale scores
2. Proportion of patients in remission from bingeing, vomiting and laxative abuse
3. Treatment adherence
Overall trial start date
01/01/2004
Overall trial end date
01/04/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Referrals to the Maudsley Eating Disorders Unit will be eligible for inclusion in the study if they fulfil DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, IVth Edition) criteria for BN (Bulimia Nervosa), or partial BN (eating disorder not otherwise specified).
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Actual number recruited = 97; power calculation suggests 94 needed.
Participant exclusion criteria
1. Insufficient knowledge of English or literacy levels insufficient to allow understanding of the CD-ROM programme
2. Anorexia nervosa or psychosis
3. Active suicidality
4. Severe substance dependence or diabetes
5. Pregnancy
Recruitment start date
01/01/2004
Recruitment end date
01/04/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Section of Eating Disorders
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
G.Dale@iop.kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Psychiatry Research Trust (UK)
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
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19043154
Publication citations
-
Results
Schmidt U, Andiappan M, Grover M, Robinson S, Perkins S, Dugmore O, Treasure J, Landau S, Eisler I, Williams C, Randomised controlled trial of CD-ROM-based cognitive-behavioural self-care for bulimia nervosa., Br J Psychiatry, 2008, 193, 6, 493-500, doi: 10.1192/bjp.bp.107.046607.