ISRCTN51304415.
| Study name | 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 |
| Methods | RCT |
| Participants | 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 |
| Interventions | One year of 1. MCT (outpatient) 2. specialist supportive clinical management |
| Outcomes | Primary: Eating disorder symptoms Secondary: 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) |
| Starting date | 01 April 2011 |
| Contact information | Dr Paul Robinson, Research Department, St. Ann's Hospital, London; drpaulrobinson@gmail.com |
| Notes |