Welcome
Support Centre
18 April 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
A Maudsley outpatient study of treatments for anorexia nervosa and related conditions
ISRCTN ISRCTN67720902
DOI 10.1186/ISRCTN67720902
ClinicalTrials.gov identifier
EudraCT number
Public title A Maudsley outpatient study of treatments for anorexia nervosa and related conditions
Scientific title A randomised controlled trial of the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA) compared to specialist supportive clinical management (SSCM) in outpatients with anorexia nervosa or eating disorder not otherwise specified (ED-NOS)
Acronym MOSAIC
Serial number at source N/A
Study hypothesis The Maudsley Model of therapy (MANTRA) will be superior to specialist supportive clinical management (SSCM) in producing greater weight-gain and greater improvement in eating-disorders related psychopathology in adults with anorexia nervosa (AN). Also it is hypothesised that MANTRA will be less costly than SSCM, specifically it will be associated with fewer hospitalisations during treatment compared to SSCM. Also, MANTRA will be more cost-effective than SSCM showing greater reduction in symptoms at lower costs.

Please note that as of 26/10/2012, the target number of participants for this trial was updated from 223 to 140.
Lay summary Not provided at time of registration
Ethics approval UCLH Research Ethics Committee A approved on the 27th April 2010 (ref: 10/H0714/9)
Study design Multicentre randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Anorexia nervosa (AN)/eating disorder not otherwise specified (EDNOS).
Participants - inclusion criteria 1. Aged 18 years and above, either sex
2. Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for anorexia nervosa or AN-type eating disorder not otherwise specified (EDNOS)
3. Body mass index (BMI) below 18.5 kg/m^2
Participants - exclusion criteria 1. Life-threatening AN requiring immediate hospitalisation or in-patient treatment
2. Insufficient knowledge of English to understand treatment and assessments
3. Learning difficulty
4. Mental or physical illness requiring treatment in its own right
5. Substance dependence
6. Pregnancy
Anticipated start date 01/04/2010
Anticipated end date 01/04/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 140
Interventions MANTRA:
A cognitive interpersonal therapy which aims to target factors involved in the development and maintenance of AN, including:
1. Thinking styles
2. Social-emotional factors
3. Pro-anorexia beliefs
4. Responses of close others to the illness
It employs a motivational interviewing style following a manual that can be tailored to meet individual patient needs.

SSCM:
A treatment designed to mimic outpatient treatment that could be offered to individuals with AN in usual clinical practice, combining aspects of clinical management and supportive psychotherapy. The focus is on resumption of normal eating and weight restoration.

Both treatments will involve 20 once-weekly hour-long sessions of therapy followed by 4-monthly follow-up sessions. Participants with very low weight (BMI less than 15 kg/m^2) will be offered 30 once-weekly sessions. Clinicians in both treatment conditions will be responsible for the monitoring of physical risk to patients throughout treatment and follow-up. Patients will also have access to a dietetic assessment and follow-up sessions as needed throughout the trial.
Primary outcome measure(s) Current primary outcome measures as of 26/10/2012:
Body mass index (BMI; kg/m^2), and Eating Disorders Examination (EDE) Global Score to assess eating disorder symptomology.
Outcomes will be measured at baseline, 6 months, 12 months and 24 months. Potential mediators and moderators will be examined at 3 months.

Previous primary outcome measures until 26/10/2012:
Body mass index (BMI; kg/m^2), and Eating Disorders Examination (EDE) Global Score to assess eating disorder symptomology.
Outcomes will be measured at baseline, 6 months, and 12 months. Potential mediators and moderators will be examined at 3 months. Some long term outcomes will be measured at 24 months - BMI, Eating Disorders Examination, Client Services Reciept Interview and Clinical Impairment Assessment.
Secondary outcome measure(s) Current secondary outcome measures as of 26/10/2012:
1. EDE subscale scores
2. Depression, Anxiety and Stress Scale (DASS-21)
3. Obsessive Compulsive Inventory (OCI)
4. The Cognitive Flexibility Scale
5. Beliefs about Emotions Scale
6. Emotion Regulation Questionnaire
7. Motivational and Social Visual Analogue Scales
8. Client Services Receipt Interview (CSRI)
9. The Clinical Impairment Assessment (CIA)
10. Treatment credibility and acceptability Visual Analogue Scales
11. Neurocognitive measures:
11.1. Brixton Spatial Anticipation Task
11.2. Wisconsin Card Sorting Task
11.3. Rey-Osterreith Complex Figure Test
12. Social Cognitive Measures:
12.1 Reading the Mind in the Film
Outcomes will be measured at baseline, 6 months, 12 months and 24 months. Potential mediators and moderators will be examined at 3 months.

Previous secondary outcome measures until 26/10/2012:
1. EDE subscale scores
2. Depression, Anxiety and Stress Scale (DASS-21)
3. Obsessive Compulsive Inventory (OCI)
4. Cognitive Behavioural Transprocesses Questionnaire
5. Social Comparison Rating Scale
6. The Vulnerable Attachment Style Questionnaire (VASQ)
7. The Cognitive Flexibility Scale
8. Beliefs about Emotions Scale
9. Emotion Regulation Questionnaire
10. Motivational and Social Visual Analogue Scales
11. Client Services Receipt Interview (CSRI)
12. The Clinical Impairment Assessment (CIA)
13. Treatment credibility and acceptability Visual Analogue Scales
14. Neurocognitive measures:
14.1. Brixton Spatial Anticipation Task
14.2. Trail Making Task
14.3. Rey-Osterreith Complex Figure Test
15. Social Cognitive Measures: Reading the Mind in the Film and Interpersonal Perception Task
16. Genetic measures: Cheek swab for genotyping
Outcomes will be measured at baseline, 6 months, and 12 months. Potential mediators and moderators will be examined at 3 months. Some long term outcomes will be measured at 24 months - BMI, Eating Disorders Examination, Client Services Reciept Interview and Clinical Impairment Assessment.
Sources of funding National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1043)
Trial website http://www.eatingresearch.com
Publications 1. 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23721562
Contact name Prof  Ulrike  Schmidt
  Address PO 59 (Section of Eating Disorders)
Institute of Psychiatry
De Crespigny Park
  City/town London
  Zip/Postcode SE5 8AF
  Country United Kingdom
  Tel +44 (0)20 7848 0181
  Fax +44 (0)20 7848 0182
  Email ulrike.schmidt@kcl.ac.uk
Sponsor Institute of Psychiatry (UK)
  Address c/o Ms. Jenny Liebscher
SLaM/IoP R&D Office, Room W 1.08
De Crespigny Park
  City/town London
  Zip/Postcode SE5 8AF
  Country United Kingdom
  Tel +44 (0)20 7848 0251
  Fax +44 (0)20 7848 0147
  Email jennifer.liebscher@kcl.ac.uk
  Sponsor website: http://www.iop.kcl.ac.uk/
Date applied 22/02/2010
Last edited 25/10/2013
Date ISRCTN assigned 15/04/2010
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.