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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN62920529 |
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Date of registration:
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14/10/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Maudsley Model of Anorexia Nervosa Treatment for Adults
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Scientific title:
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A preliminary randomised controlled trial of the efficacy and acceptability of a new cognitive-interpersonal treatment of anorexia nervosa versus non-specific supportive clinical management |
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Date of first enrolment:
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01/03/2007 |
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Target sample size:
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66 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN62920529 |
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Study type:
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Interventional |
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Study design:
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Two-armed single-blind randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Ulrike
Schmidt |
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Address:
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PO Box 59
Institute of Psychiatry
De Crespigny Park
SE5 8AF
London
United Kingdom |
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Telephone:
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+44 (0)20 7848 0181 |
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Email:
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u.schmidt@iop.kcl.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Outpatients aged 18 or over, either sex
2. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) anorexia nervosa or Eating Disorder Not Otherwise Specified
3. Body mass index of 18.5 kg/m^2 or below
Exclusion criteria: 1. Life-threatening AN requiring immediate in-patient treatment as defined in the UK National Institute for Health and Clinical Excellence (NICE) guidelines for eating disorders
2. Insufficient knowledge of English to understand the treatment
3. Learning disability, severe mental or physical illness
4. Needing treatment in its own right (e.g. psychosis or diabetes mellitus)
5. Substance dependency
6. Pregnancy
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anorexia nervosa
Mental and Behavioural Disorders
Eating disorders
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Intervention(s)
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Two different psychological interventions of 20 individual sessions each plus four follow-up meetings, two sessions with close others and two sessions with a dietician:
1. Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA): This is a manualised cognitive-interpersonal treatment which focuses on addressing four key maintaining factors of anorexia nervosa
2. Specialist Supportive Clinical Management (SSCM): This manualised treatment is designed to be delivered by health professionals trained in the treatment of eating disorders and aims "to mimic outpatient treatment that could be offered to individuals with AN in usual clinical practice"
Total duration of treatment is 6 months and total duration of follow-up is also 6 months (after the end of treatment). This is the same for both treatments.
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Primary Outcome(s)
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Measured at pre-treatment (baseline), 6 months and 12 months post-randomisation:
1. Body mass index
2. Eating Disorders Examination Global Score
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Secondary Outcome(s)
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Measured at pre-treatment (baseline), 6 months and 12 months post-randomisation:
1. Eating Disorders Examination Subscales
2. Clinical Impairment Assessment (CIA) questionnaire
3. Hospital Anxiety and Depression Scale (HADS)
4. Embedded Figures Task
5. Brixton Spatial Anticipation Task
6. Wisconsin Card Sorting Task
7. Trail making task
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Secondary ID(s)
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29 Eating Disorders (79)
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Source(s) of Monetary Support
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Psychiatry Research Trust (UK) - http://www.psychiatryresearch.org.uk (ref: 29 Eating Disorders (79))
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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