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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51304415
Enrollment
140
Registered
2011-04-19
Start date
2011-04-01
Completion date
Unknown
Last updated
2016-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating disorders/borderline personality disorder Mental and Behavioural Disorders Eating disorders

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

Sponsors

Barnet Enfield and Haringey Mental Health Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 21, 2026