Maudsley Model of Anorexia Nervosa Treatment for Adults
| ISRCTN | ISRCTN62920529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62920529 |
| Secondary identifying numbers | 29 Eating Disorders (79) |
- Submission date
- 01/10/2009
- Registration date
- 14/10/2009
- Last edited
- 08/05/2013
- 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 Box 59
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7848 0181 |
|---|---|
| u.schmidt@iop.kcl.ac.uk |
Study information
| Study design | Two-armed single-blind 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 below to request a patient information sheet |
| Scientific title | A preliminary randomised controlled trial of the efficacy and acceptability of a new cognitive-interpersonal treatment of anorexia nervosa versus non-specific supportive clinical management |
| Study acronym | MANTRA |
| Study objectives | A specific, empirically-based treatment model focusing on four core maintenance factors (Maudsley model of Anorexia Nervosa Treatment for Adults [MANTRA]) will be superior to non-specific supportive clinical management (SSCM) in producing greater weight gain and greater improvement in eating-disorder related psychopathology in adults with anorexia nervosa (AN) at end of treatment (6 months) and follow-up (12 months). |
| Ethics approval(s) | The Institute of Psychiatry/South London and Maudsley NHS Foundation Trust Research Ethics Committee approved on the 20th November 2006 (ref: 06/Q0706/105) |
| Health condition(s) or problem(s) studied | Anorexia nervosa |
| Intervention | Two different psychological interventions of 20 individual sessions each plus four follow-up meetings, two sessions with close others and two sessions with a dietician: 1. Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA): This is a manualised cognitive-interpersonal treatment which focuses on addressing four key maintaining factors of anorexia nervosa 2. Specialist Supportive Clinical Management (SSCM): This manualised treatment is designed to be delivered by health professionals trained in the treatment of eating disorders and aims "to mimic outpatient treatment that could be offered to individuals with AN in usual clinical practice" Total duration of treatment is 6 months and total duration of follow-up is also 6 months (after the end of treatment). This is the same for both treatments. |
| Intervention type | Other |
| Primary outcome measure | Measured at pre-treatment (baseline), 6 months and 12 months post-randomisation: 1. Body mass index 2. Eating Disorders Examination Global Score |
| Secondary outcome measures | Measured at pre-treatment (baseline), 6 months and 12 months post-randomisation: 1. Eating Disorders Examination Subscales 2. Clinical Impairment Assessment (CIA) questionnaire 3. Hospital Anxiety and Depression Scale (HADS) 4. Embedded Figures Task 5. Brixton Spatial Anticipation Task 6. Wisconsin Card Sorting Task 7. Trail making task |
| Overall study start date | 01/03/2007 |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 66 |
| Key inclusion criteria | 1. Outpatients aged 18 or over, either sex 2. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) anorexia nervosa or Eating Disorder Not Otherwise Specified 3. Body mass index of 18.5 kg/m^2 or below |
| Key exclusion criteria | 1. Life-threatening AN requiring immediate in-patient treatment as defined in the UK National Institute for Health and Clinical Excellence (NICE) guidelines for eating disorders 2. Insufficient knowledge of English to understand the treatment 3. Learning disability, severe mental or physical illness 4. Needing treatment in its own right (e.g. psychosis or diabetes mellitus) 5. Substance dependency 6. Pregnancy |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 01/06/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
PO Box 59
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
c/o Jenny Liebscher
R&D Governance and Delivery Manager
SLaM/IoP R&D Office, Room W 1.08
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
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
Charity
Psychiatry Research Trust (UK) - http://www.psychiatryresearch.org.uk (ref: 29 Eating Disorders (79))
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? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2012 | Yes | No |
