Condition category
Mental and Behavioural Disorders
Date applied
22/02/2010
Date assigned
15/04/2010
Last edited
25/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.eatingresearch.com

Contact information

Type

Scientific

Primary contact

Prof Ulrike Schmidt

ORCID ID

Contact details

PO 59 (Section of Eating Disorders)
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0181
ulrike.schmidt@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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.

Ethics approval

UCLH Research Ethics Committee A approved on the 27th April 2010 (ref: 10/H0714/9)

Study design

Multicentre 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 (AN)/eating disorder not otherwise specified (EDNOS).

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/04/2010

Overall trial end date

01/04/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant 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

Recruitment start date

01/04/2010

Recruitment end date

01/04/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

PO 59 (Section of Eating Disorders)
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

Institute of Psychiatry (UK)

Sponsor details

c/o Ms. Jenny Liebscher
SLaM/IoP R&D Office
Room W 1.08
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0251
jennifer.liebscher@kcl.ac.uk

Sponsor type

Research organisation

Website

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

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1043)

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. 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23721562

Publication citations

  1. Protocol

    Schmidt U, Renwick B, Lose A, Kenyon M, Dejong H, Broadbent H, Loomes R, Watson C, Ghelani S, Serpell L, Richards L, Johnson-Sabine E, Boughton N, Whitehead L, Beecham J, Treasure J, Landau S, The MOSAIC study - comparison of the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with anorexia nervosa or eating disorder not otherwise specified, anorexia nervosa type: study protocol for a randomized controlled trial., Trials, 2013, 14, 160, doi: 10.1186/1745-6215-14-160.

Additional files

Editorial Notes