Condition category
Mental and Behavioural Disorders
Date applied
01/10/2009
Date assigned
14/10/2009
Last edited
08/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.iop.kcl.ac.uk

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22995632

Publication citations

  1. 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.

Additional files

Editorial Notes