A Maudsley outpatient study of treatments for anorexia nervosa and related conditions

ISRCTN	ISRCTN67720902
DOI	https://doi.org/10.1186/ISRCTN67720902
Protocol serial number	N/A
Sponsor	Institute of Psychiatry (UK)
Funder	National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1043)

Submission date: 22/02/2010
Registration date: 15/04/2010
Last edited: 12/09/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ulrike Schmidt
Scientific

PO 59 (Section of Eating Disorders)
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Phone	+44 (0)20 7848 0181
Email	ulrike.schmidt@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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)
Study acronym	MOSAIC
Study objectives	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(s)	UCLH Research Ethics Committee A, 27/04/2010, ref: 10/H0714/9
Health condition(s) or problem(s) studied	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
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.
Key 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.
Completion date	01/04/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	140
Key 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
Key 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
Date of first enrolment	01/04/2010
Date of final enrolment	01/04/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Psychiatry

London
SE5 8AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2017		Yes	No
Protocol article	protocol	30/05/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/09/2017: Publication reference added.
26/10/2012: The target number of participants was changed from 223 to 140.