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 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.
Ethics approval
UCLH Research Ethics Committee A, 27/04/2010, 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 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 measure
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 (if study stopped)
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
Institute of Psychiatry
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
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
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23721562
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28872815
Publication citations
-
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.