Maudsley Model of Anorexia Nervosa Treatment for Adults

ISRCTN	ISRCTN62920529
DOI	https://doi.org/10.1186/ISRCTN62920529
Protocol serial number	29 Eating Disorders (79)
Sponsor	King's College London (UK)
Funder	Psychiatry Research Trust (UK) - http://www.psychiatryresearch.org.uk (ref: 29 Eating Disorders (79))

Submission date: 01/10/2009
Registration date: 14/10/2009
Last edited: 08/05/2013

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

Prof Ulrike Schmidt
Scientific

PO Box 59
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

Primary study design	Interventional
Study design	Two-armed single-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study acronym	MANTRA
Study objectives	A specific, empirically-based treatment model focusing on four core maintenance factors (Maudsley model of Anorexia Nervosa Treatment for Adults [MANTRA]) will be superior to non-specific supportive clinical management (SSCM) in producing greater weight gain and greater improvement in eating-disorder related psychopathology in adults with anorexia nervosa (AN) at end of treatment (6 months) and follow-up (12 months).
Ethics approval(s)	The Institute of Psychiatry/South London and Maudsley NHS Foundation Trust Research Ethics Committee approved on the 20th November 2006 (ref: 06/Q0706/105)
Health condition(s) or problem(s) studied	Anorexia nervosa
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	Measured at pre-treatment (baseline), 6 months and 12 months post-randomisation: 1. Body mass index 2. Eating Disorders Examination Global Score
Key secondary outcome measure(s)	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
Completion date	01/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	66
Key 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
Key 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
Date of first enrolment	01/03/2007
Date of final enrolment	01/06/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

PO Box 59

London
SE5 8AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes