A Maudsley outpatient study of treatments for anorexia nervosa and related conditions
| ISRCTN | ISRCTN67720902 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67720902 |
| Secondary identifying numbers | N/A |
- 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
Scientific
PO 59 (Section of Eating Disorders)
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7848 0181 |
|---|---|
| ulrike.schmidt@kcl.ac.uk |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 01/04/2010 |
| Completion date | 01/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Institute of Psychiatry
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
Institute of Psychiatry (UK)
Research organisation
Research organisation
c/o Ms. Jenny Liebscher
SLaM/IoP R&D Office, Room W 1.08
De Crespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7848 0251 |
|---|---|
| jennifer.liebscher@kcl.ac.uk | |
| Website | http://www.iop.kcl.ac.uk/ |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0606-1043)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 30/05/2013 | Yes | No | |
| Results article | results | 01/08/2017 | Yes | No |
Editorial Notes
12/09/2017: Publication reference added.
26/10/2012: The target number of participants was changed from 223 to 140.
