Nice OUtcomes for Referrals with Impulsivity, Self Harm and Eating Disorders: The NOURISHED Study

ISRCTN	ISRCTN51304415
DOI	https://doi.org/10.1186/ISRCTN51304415
Protocol serial number	N/A
Sponsor	Barnet Enfield and Haringey Mental Health Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB PG 0408 15183)

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 of protocol

Not provided at time of registration

Contact information

Dr Paul Robinson
Scientific

Research Department
St Ann's Hospital Block H
St Ann's Road
London
N15 3TH
United Kingdom

Phone	+44 (0)20 8442 6503
Email	drpaulrobinson@gmail.com

Study information

Primary study design	Interventional
Study design	Multicentre randomised single-blind controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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(s)	Eating disorder symptoms will be measured 6-monthly using the global score of the Eating Disorder Examination (Time points: 0, 6, 12, 18 months)
Key secondary outcome measure(s)	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)
Completion date	31/07/2013

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 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
Key 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)
Date of first enrolment	01/04/2011
Date of final enrolment	31/07/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

St Ann's Hospital

London
N15 3TH
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	17/11/2016		Yes	No
Protocol article	protocol	21/02/2014		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

21/11/2016: Publication reference added.