A preliminary randomised controlled trial of the efficacy of a CD-ROM based cognitive-behavioural self-help intervention for bulimia nervosa

ISRCTN ISRCTN51564819
DOI https://doi.org/10.1186/ISRCTN51564819
Secondary identifying numbers LREC 217/00
Submission date
15/01/2004
Registration date
15/01/2004
Last edited
10/12/2008
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 of protocol

Not provided at time of registration

Contact information

Dr Ulrike Schmidt
Scientific

Section of Eating Disorders
Box 059
Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Phone +44 (0)20 7848 0181
Email U.Schmidt@iop.kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesHypothesis 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(s)Received from the Institute of Psychiatry Research Ethics Committtee on the 17th October 2003 (ref: 217/00).
Health condition(s) or problem(s) studiedBulimia nervosa
InterventionARM 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 typeOther
Primary outcome measure1. Eating Disorders Examination Global Score
2. Frequencies of binges and vomiting over the previous 28 days
Secondary outcome measures1. Eating Disorders Examination Subscale scores
2. Proportion of patients in remission from bingeing, vomiting and laxative abuse
3. Treatment adherence
Overall study start date01/01/2004
Completion date01/04/2006

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participantsActual number recruited = 97; power calculation suggests 94 needed.
Key inclusion criteriaReferrals 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).
Key exclusion criteria1. 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
Date of first enrolment01/01/2004
Date of final enrolment01/04/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Section of Eating Disorders
London
SE5 8AF
United Kingdom

Sponsor information

King's College London (UK)
University/education

Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom

Email G.Dale@iop.kcl.ac.uk
Website http://www.iop.kcl.ac.uk/
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Research organisation

Psychiatry Research Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2008 Yes No