Coef (change in ZAN from baseline) CONTACT and ACKNOWLEDGEMENTS A Randomized Controlled Trial of Mentalization Based Therapy (ED) against Specialist Supportive Clinical Management (ED) in patients with both Eating Disorders and symptoms of Borderline Personality Disorder The NOURISHED Study *Paul Robinson 1,2, * Jennifer Hellier 4, Caroline Murphy 4, Barbara Barrett 4, Clare Rutterford 4, Fenella Lemonsky 5, Ulrike Schmidt 4, Nicola Kern 6, Daiva Barzdaitiene, 7, Az Hakeem 8, Alex Bogaardt 1, Ajay Clare 1, Anthony Bateman 1, 2, and Peter Fonagy 2, 3 Barnet Enfield and Haringey Mental Health Trust, 2. University College London, 3. Anna Freud Centre, 4. Kings College London, 5. Expert by experience, 6. South London and The Maudsley NHS Trust, 7. Kent and Medway NHS Trust, 8. Camden and Islington NHS Trust * Joint first authors ABSTRACT METHODS - continued Preliminary RESULTS RESULTS continued CONCLUSIONS Instruments used Eating Disorders Examination (EDE) (EDE-Q at 36 months) Reflective Function Questionnaire (RFQ) Reading the mind in the eyes test Object Relations Inventory (ORI) Acts of Deliberate Self Harm Inventory (ADSHI) MINI International Neuropsychiatric Schedule (MINI) Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) Global Assessment of Functioning (GAF) Zanarini-BPD (ZAN-BPD) Euroqol (EQ5D) Depression, Anxiety, Stress Scales -21 (DASS 21) Modified Social Adjustment Scale (SAS) Adult Service Use Schedule (AD-SUS) Big Five personality Inventory (BFI) Apart from the MINI and the SCID II which are only administered at baseline for diagnostic purposes, all instruments were repeated at 6, 12 and 18 months post randomization. At 36 months, the EDE-Q, the RFQ, the ZAN-BPD, and the DASS were used. 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. Primary outcome was the Global EDE score, compared between the two therapies. Interim results: Drop-out was high, with 37% attending for 12 month follow up and 22% at 18 months. However, using Linear Mixed Models analysis, up to 18 months, global EDE score, the primary outcome measure, had significantly improved in both treatment groups by a mean of 0.9 units. Analysis of subscales showed that the MBT-ED had significantly lower Shape Concern and Weight Concern scores compared to SSCM-ED. 36 month results and secondary outcomes are being analysed. Discussion: This is the first Randomised Controlled Trial of MBT-ED in patients with eating disorders and symptoms of BPD. During MBT-ED mentalization is encouraged, while in SSCM-ED it is not overtly addressed. Early indications are that both therapies appeared helpful, with MBT-ED perhaps having more influence on ED psychopathology. Adverse outcomes There were 10 adverse events including hospital admission for self harm and weight loss with no difference between groups. There was one death in a patient who was receiving MBT-ED. The inquest recorded a verdict of unexplained adult sudden death with no evidence (including toxicology) of self harm or other identifiable cause. Consort diagram A further (postal) follow up was performed at 36 months with 21 participants responding Changes in EDE scores (Eating Disorder symptoms) over time This study has now ended and analysis is continuing. However, certain tentative conclusions can be reached. The population treated was of high morbidity and this may have contributed to the drop out rate. Methodologies for implementing the two novel therapies MBT-ED and SSCM-ED have been established and manuals written. Recruitment was slower than anticipated mainly because of the training requirements for MBT-ED which delayed the onset of treatment. Participants were overwhelmingly suffering from Bulimia Nervosa and Borderline Personality Disorder. Both treatment groups showed a reduction of eating disorder symptoms comparable to that seen in other therapy trials and there was some evidence that MBT-ED might reduce eating disorder symptoms more that SSCM-ED. Both groups also showed a significant reduction in BPD symptoms. 3 year follow up results will be analysed together with the present result. Overall this trial should be seen as a feasibility and pilot study . The results encourage the use of both MBT-ED and SSCM-ED in further trials, for example in patients who have failed to respond to currently available evidence based approaches. EDE outcomes over 18 mth. The Global EDE score (top) declines significantly over time with no difference between treatments. Weight Concern (mid) and Shape Concern (below) show a significant treatment effect in favour of MBT-ED against SSCM-ED at 12 and 18 months. REFERENCES McIntosh, V. V., et al. (2006). "Specialist supportive clinical management for anorexia nervosa." The International journal of eating disorders 39(8): 625-632. Robinson, P., et al. (2014). "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 14 (1): 51. Robinson P H (2013) Mentalization Based Therapy of non-suicidal self injury and eating disorders. In Non-suicidal self injury in eating disorders. Eds Claes, L, Muehelkamp. Publ: Springer Skårderud, F., Fonagy, P (2012). Eating Disorders. Handbook of mentalizing in Mental Health Practice. A. a. F. Bateman, P. Arlington, VA American Psychiatric Publishing Inc. 347-384. OBJECTIVES Primary objective To ascertain whether Mentalization Based Therapy (Skårderud et al 2012) is clinically effective at reducing observer rated symptoms of Eating Disorder, using an accepted measure, the Eating Disorders Examination, in patients with combined eating and borderline personality disorder symptoms up to 18 months post randomisation compared to Specialist Supportive Clinical Management (Mcintosh et al 2006). Secondary objectives To ascertain whether Mentalization Based Therapy is cost effective at reducing observer rated symptoms of Eating Disorder, using an accepted measure, the Eating Disorders Examination, in patients with combined eating and borderline personality disorder symptoms up to 18 months post randomisation compared to Specialist Supportive Clinical Management. To determine whether Mentalization Based Therapy is clinically effective at reducing symptoms of Borderline Personality Disorder as measured by the Zanarini-BPD scale, an accepted measure of BPD symptoms in patients with combined eating disorders and borderline personality disorder symptoms up to 18 months post randomisation compared to Specialist Supportive Clinical Management. To examine participant outcome at an average of 36 months post randomization. To ascertain whether adverse events in the two groups differ. To ascertain whether MBT is a cost-effective treatment for BPD compared to SSCM. 
   EDE diagnoses MBT-ED N=34 SSCM-ED Total N=68 AN 2 (6%) 4 (6%) BN 22 (65%) 21 (62%) 43 (63%) BED 0 (0%) 2 (3%) EDNOS 8 (24%) 11 (32%) 19 (28%) METHODS (see Robinson et al 2014) Changes in ZAN-BPD (Borderline PD symptoms) over time: Overall significant fall, but no difference between treatments. Data from whole group. This was a multi-centre study across three NHS Eating Disorder Units in three different NHS Trusts. The design is a single-blind (researchers being blind) randomised controlled trial of Mentalization Based Therapy for eating disorders (MBT-ED) (Robinson 2013), with an intensity of one individual and one group session per week for one year, compared to Specialist Supportive Clinical Management adapted for all eating disorders (SSCM-ED), a standard treatment for eating disorders, which comprises one session every 1 to 4 weeks for 20 to 26 sessions All trial participants had access to up to 5 hours of dietetic advice over the course of treatment. Participants were recruited from the participating clinics and included both new referrals and patients currently receiving care. Randomisation was remote to ensure researcher blindness to treatment allocation. Treatment began following randomization for 12 months (MBT-ED) or for up to 12 months (SSCM-ED). All participants were asked to complete assessment questionnaires and to participate in assessment interviews at 6, 12 and 18 months follow-up. A further postal follow up was conducted at 36 months.   Zan Global Coef (change in ZAN from baseline) Std. Err. P>z [95% Conf. Interval] 6 Months -2.418 0.745 0.001 -3.877 -0.958 12 Months -4.835 1.489 -7.754 -1.916 18 Months -7.253 2.234 -11.632 -2.875 Axis II diagnosis (SCID-II) MBT-ED N=32 SSCM-ED N=31 Total N=63 Avoidant Personality Disorder 2 (6.3%) 0 (0%) 2 (3.2%) Depressive Personality Disorder 5 (15.6%) 3 (9.7%) 8 (12.7%) Borderline Personality Disorder 23 (71.9%) 25 (80.7%) 48 (76.2%) No axis II Disorder 5 (7.9%) CONTACT and ACKNOWLEDGEMENTS Dr Paul Robinson, Research Dept, St Ann’s Hospital, London N15 3TH p.robinson@ucl.ac.uk Development of the grant application was ably assisted by the North Central London Research Consortium to which organization we express our gratitude. This poster presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0408-15183). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. After the end of the NIHR grant, the trial was generously funded by Barnet Enfield and Haringey Mental Health Trust for a further year for which we are very grateful.