Condition category
Mental and Behavioural Disorders
Date applied
15/01/2004
Date assigned
15/01/2004
Last edited
10/12/2008
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

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 measures

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

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

http://www.iop.kcl.ac.uk/

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19043154

Publication citations

  1. 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.

Additional files

Editorial Notes