Nice OUtcomes for Referrals with Impulsivity, Self Harm and Eating Disorders: The NOURISHED Study | Not Recruiting
Nice OUtcomes for Referrals with Impulsivity, Self Harm and Eating Disorders: The NOURISHED Study
The NOURISHED Study
Trial Source

Health Conditions
  • Eating disorders/borderline personality disorder
Not Recruiting
Recruitment Status
ISRCTN51304415
Primary Trial ID Number
Summary
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.
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)
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
South East Research Ethics Committee approved on the 14/12/2010 (ref: 10/H1102/2)
Publications
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24555511
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
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)
Interventions
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.
Design Details
Sorry, this information is not available
Study Design
Multicentre randomised single blind controlled trial
Results Reporting
Sorry, this information is not available
Acronym
The NOURISHED Study
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
Secondary Trial Identifying Number
N/A
Website
http://www.nourished-project.co.uk/
Study Funded By
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB PG 0408 15183)
Funder Type
Sorry, this information is not available
Study Sponsored By
Barnet Enfield and Haringey Mental Health Trust (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 Apr 2011

Recruitment End Date

31 Jul 2013

Trial End Date

31 Jul 2013

Date added to Registry

19 Apr 2011

Last Updated

24 Feb 2014