Open Access Study protocol

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

Paul Robinson12*, Barbara Barrett3, Anthony Bateman4, Az Hakeem5, Jennifer Hellier6, Fenella Lemonsky7, Clare Rutterford8, Ulrike Schmidt9 and Peter Fonagy10

Author Affiliations

1 Division of Psychiatry, University College London, Gower Street, London WC1E 6BT, UK

2 Research and Development Department, Barnet Enfield and Haringey Mental Health Trust, St Ann’s Hospital, St Ann’s Road, London N15 3TH, UK

3 Department of Health Economics, Institute of Psychiatry, de Crespigny Park, London SE5 8AF, UK

4 Halliwick Centre, St Ann’s Hospital, St Ann’s Road, London N15 3TH, UK

5 The Dartmouth Park Unit, London N19 5NX, UK

6 Department of Biostatistics, King's College Clinical Trials Unit, Institute of Psychiatry, King's College London, London SE5 8AF, UK

7 Expert by Experience, London, UK

8 King's College Clinical Trials Unit, Institute of Psychiatry, King's College London, London SE5 8AF, UK

9 Section of Eating Disorders, Institute of Psychiatry, de Crespigny Park, London SE5 8AF, UK

10 Psychology Department, University College London, Gower Street, London WC1E 6BT, UK

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BMC Psychiatry 2014, 14:51  doi:10.1186/1471-244X-14-51

Published: 21 February 2014

Abstract

Background

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

Eating Disorders (ED) and Borderline Personality Disorder (BPD) are both difficult to treat and the combination presents particular challenges. Both are associated with vulnerability to loss of mentalization (awareness of one’s own and others’ emotional state). In BPD, Mentalization Based therapy (MBT) has been found effective in reducing symptoms. In this trial we investigate the effectiveness and cost-effectiveness of MBT adapted for Eating disorders (Mentalization Based Therapy for Eating Disorders (MBT-ED)) compared to a standard comparison treatment, Specialist Supportive Clinical Management (SSCM-ED) in patients with a combination of an Eating Disorder and either a diagnosis of BPD or a history of self-harm and impulsivity in the previous 12 months.

Methods/Design

We will complete a multi-site single-blind randomized controlled trial (RCT) of MBT-ED vs SSCM-ED. Participants will be recruited from three Eating Disorder Services and two Borderline Personality Disorder Services in London. Participants allocated to MBT-ED will receive one year of weekly group and individual therapy and participants allocated to SSCM-ED will receive 20 sessions of individual therapy over 1 year. In addition, participants in both groups will have access to up to 5 hours of dietetic advice. The primary outcome measure is the global score on the Eating Disorders Examination. Secondary outcome measures include total score on the Zanarini BPD scale, the Object Relations Inventory, the Depression Anxiety Stress Scales, quality of life and cost-effectiveness. Measures are taken at recruitment and at 6 month intervals up to 18 months.

Discussion

This is the first Randomised Controlled Trial of MBT-ED in patients with eating disorders and symptoms of BPD and will provide evidence to inform therapy decisions in this group of patients. During MBT-ED mentalization is encouraged, while in SSCM-ED it is not overtly addressed. This study will help elucidate mechanisms of change in the two therapies and analysis of therapy and interview transcripts will provide qualitative information about the conduct of therapy and changes in mentalization and object relations.

Trial registration

ISRCTN51304415

Keywords:
Borderline; Anorexia; Bulimia; Mentalization; Self-harm; Psychotherapy; Attachment; Personality; RCT; Eating