Contact information
Type
Scientific
Primary contact
Prof Ulrike Schmidt
ORCID ID
Contact details
PO Box 59
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
29 Eating Disorders (79)
Study information
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
Acronym
MANTRA
Study hypothesis
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
The Institute of Psychiatry/South London and Maudsley NHS Foundation Trust Research Ethics Committee approved on the 20th November 2006 (ref: 06/Q0706/105)
Study design
Two-armed single-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
Measured at pre-treatment (baseline), 6 months and 12 months post-randomisation:
1. Body mass index
2. Eating Disorders Examination Global Score
Secondary outcome measures
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
Overall trial start date
01/03/2007
Overall trial end date
01/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
66
Participant 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
Recruitment start date
01/03/2007
Recruitment end date
01/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
PO Box 59
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
c/o Jenny Liebscher
R&D Governance and Delivery Manager
SLaM/IoP R&D Office
Room W 1.08
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0251
jennifer.liebscher@kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Psychiatry Research Trust (UK) - http://www.psychiatryresearch.org.uk (ref: 29 Eating Disorders (79))
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22995632
Publication citations
-
Results
Schmidt U, Oldershaw A, Jichi F, Sternheim L, Startup H, McIntosh V, Jordan J, Tchanturia K, Wolff G, Rooney M, Landau S, Treasure J, Out-patient psychological therapies for adults with anorexia nervosa: randomised controlled trial., Br J Psychiatry, 2012, 201, 5, 392-399, doi: 10.1192/bjp.bp.112.112078.