Condition category
Mental and Behavioural Disorders
Date applied
31/01/2011
Date assigned
19/04/2011
Last edited
21/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.nourished-project.co.uk/

Contact information

Type

Scientific

Primary contact

Dr Paul Robinson

ORCID ID

Contact details

Research Department
St Ann's Hospital Block H
St Ann's Road
London
N15 3TH
United Kingdom
+44 (0)20 8442 6503
drpaulrobinson@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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

South East Research Ethics Committee, 14/12/2010, ref: 10/H1102/2

Study design

Multicentre randomised single-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

http://www.nourished-project.co.uk; Please click on the link for "Participant and carer information sheet"

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/04/2011

Overall trial end date

31/07/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

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

United Kingdom

Trial participating centre

St Ann's Hospital
London
N15 3TH
United Kingdom

Sponsor information

Organisation

Barnet Enfield and Haringey Mental Health Trust (UK)

Sponsor details

Trust HQ
St Ann's Hospital
St Ann's Road
London
N15 3TH
United Kingdom
+44 (0)20 8442 6000
eric.johnson-sabine@beh-mht.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.beh-mht.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB PG 0408 15183)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24555511
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27855714

Publication citations

  1. Protocol

    Robinson P, Barrett B, Bateman A, Hakeem A, Hellier J, Lemonsky F, Rutterford C, Schmidt U, Fonagy P, Study Protocol for a randomized controlled trial of mentalization based therapy against specialist supportive clinical management in patients with both eating disorders and symptoms of borderline personality disorder., BMC Psychiatry, 2014, 14, 51, doi: 10.1186/1471-244X-14-51.

Additional files

Editorial Notes

21/11/2016: Publication reference added.