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ISRCTN
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ISRCTN51564819
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ClinicalTrials.gov identifier
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Public title
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A preliminary randomised controlled trial of the efficacy of a CD-ROM based cognitive-behavioural self-help intervention for bulimia nervosa
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Scientific title
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Acronym
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N/A
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Serial number at source
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LREC 217/00
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Received from the Institute of Psychiatry Research Ethics Committtee on the 17th October 2003 (ref: 217/00).
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Bulimia nervosa
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Participants - inclusion criteria
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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).
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2004
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Anticipated end date
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01/04/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Actual number recruited = 97; power calculation suggests 94 needed.
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Interventions
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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.
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Primary outcome measure(s)
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1. Eating Disorders Examination Global Score
2. Frequencies of binges and vomiting over the previous 28 days
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Secondary outcome measure(s)
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1. Eating Disorders Examination Subscale scores
2. Proportion of patients in remission from bingeing, vomiting and laxative abuse
3. Treatment adherence
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Sources of funding
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Psychiatry Research Trust (UK)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19043154
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Contact name
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Dr
Ulrike
Schmidt
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Address
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Section of Eating Disorders
Box 059
Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
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City/town
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London
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Zip/Postcode
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SE5 8AF
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Country
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United Kingdom
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Tel
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+44 (0)20 7848 0181
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Fax
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+44 (0)20 7848 0182
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Email
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U.Schmidt@iop.kcl.ac.uk
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Sponsor
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King's College London (UK)
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Address
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Institute of Psychiatry
De Crespigny Park
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City/town
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London
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Zip/Postcode
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SE5 8AF
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Country
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United Kingdom
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Email
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G.Dale@iop.kcl.ac.uk
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Sponsor website:
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http://www.iop.kcl.ac.uk/
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Date applied
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15/01/2004
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Last edited
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10/12/2008
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Date ISRCTN assigned
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15/01/2004
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