Nice OUtcomes for Referrals with Impulsivity, Self Harm and Eating Disorders: The NOURISHED Study
| ISRCTN | ISRCTN51304415 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51304415 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/01/2011
- Registration date
- 19/04/2011
- Last edited
- 21/11/2016
- 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
Not provided at time of registration
Contact information
Dr Paul Robinson
Scientific
Scientific
Research Department
St Ann's Hospital Block H
St Ann's Road
London
N15 3TH
United Kingdom
| Phone | +44 (0)20 8442 6503 |
|---|---|
| drpaulrobinson@gmail.com |
Study information
| Study design | Multicentre randomised single-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | http://www.nourished-project.co.uk; Please click on the link for "Participant and carer information sheet" |
| Scientific title | A randomised controlled trial of mentalisation based therapy against specialist supportive clinical management in patients with both eating disorders and symptoms of borderline personality disorder |
| Study acronym | NOURISHED |
| Study hypothesis | Mentalisation based therapy is no more 1. Clinically effective 2. Cost effective at reducing observer rated symptoms of eating disorder as measured by the global score of the Eating Disorders Examination Questionnaire (EDE-Q) in patients with combined eating and borderline personality disorder symptoms up to 18 months post-randomisation than specialist supportive clinical management. |
| Ethics approval(s) | South East Research Ethics Committee, 14/12/2010, ref: 10/H1102/2 |
| Condition | Eating disorders/borderline personality disorder |
| Intervention | 1. Mentalisation Based Therapy (MBT): Intensive Outpatient program model for one year 2. Control treatment: Specialist Supportive Clinical Management (SSCM) 20 - 26 sessions over maximum one year for SSCM. Both groups receive 5 hours of dietetic advice in the year. MBT participants receive weekly individual and group therapy for one year. |
| Intervention type | Other |
| Primary outcome measure | Eating disorder symptoms will be measured 6-monthly using the global score of the Eating Disorder Examination (Time points: 0, 6, 12, 18 months) |
| Secondary outcome measures | 1. Borderline Personality Disorder symptoms will be measured 6-monthly using the total score of the ZAN-BPD (Time points 0, 6, 12, 18 months) 2. The economic evaluation will examine the costs-effectiveness of Mentalization Based Therapy and Specialist Supportive Clinical Management including an analysis of incremental cost per QALY 3. Participant rated general psychiatric symptoms of Borderline Personality Disorder will be measured 6-monthly using the DASS-21 (Time points 0, 6, 12, 18 months) 4. Possible mediators of change in Borderline Personality Disorder symptoms include reflective function and object relations, measured by the Reflective Function Questionnaire, The Reading the Mind in the Eyes test and the Object Relations Inventory and personality factors (e.g. resilience, dysregulation, restriction) thought to be important in Eating Disorders (Time points 0, 6, 12, 18 months) |
| Overall study start date | 01/04/2011 |
| Overall study end date | 31/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 140 |
| Participant inclusion criteria | 1. Aged over 18 years, either sex 2. Eating disorder diagnosis 3. Borderline personality disorder (BPD) symptoms. The criteria for "BPD symptoms" are that the patient fulfils both behavioural criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), namely: 3.1. Impulsivity in at least two areas that are potentially self-damaging (e.g., spending, sexual behaviour, substance abuse, reckless driving, binge eating) 3.2. Recurrent suicidal behaviour, or self-mutilating behaviour 4. Able and willing to provide written informed consent |
| Participant exclusion criteria | 1. Current psychosis 2. Current inpatient 3. Currently in psychological therapy 4. Received mentalisation-based treatment (MBT) less than 6 months prior to randomisation 5. Organic brain disease leading to significant cognitive impairment 6. Body mass index (BMI) less than 15 kg/m2 (normal range 19 - 25 kg/m2, anorexia nervosa less than 17.5 kg/m2) |
| Recruitment start date | 01/04/2011 |
| Recruitment end date | 31/07/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Ann's Hospital
London
N15 3TH
United Kingdom
N15 3TH
United Kingdom
Sponsor information
Barnet Enfield and Haringey Mental Health Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Trust HQ
St Ann's Hospital
St Ann's Road
London
N15 3TH
England
United Kingdom
| Phone | +44 (0)20 8442 6000 |
|---|---|
| eric.johnson-sabine@beh-mht.nhs.uk | |
| Website | http://www.beh-mht.nhs.uk/ |
"ROR" |
https://ror.org/00d2v4e22 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB PG 0408 15183)
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 | 21/02/2014 | Yes | No | |
| Results article | results | 17/11/2016 | Yes | No |
Editorial Notes
21/11/2016: Publication reference added.
