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

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  • Source

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    Public Title Nice OUtcomes for Referrals with Impulsivity, Self Harm and Eating Disorders: The NOURISHED Study
    Acronym The NOURISHED Study
    Source of Record URL http://isrctn.org/ISRCTN51304415
  • Trial

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    Health Condition(s) or Problem Eating disorders/borderline personality disorder
    Lay Summary Sorry, not currently available
    Who can enter the trial 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
    Who cannot enter the trial 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)
    What will happen 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.
    Primary aim 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 Aim 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)
    Participant Information Sheet http://www.nourished-project.co.uk Please click on the link for "Participant and carer information sheet"
    Website http://www.nourished-project.co.uk/
    Recruitment Status Recruiting
    Nation England
    Location London
  • Contact

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    Contact for Public Queries Dr Paul Robinson Research Department St Ann's Hospital Block H St Ann's Road London N15 3TH United Kingdom +44 (0)20 8442 6503 +44 (0)20 8442 6503 drpaulrobinson@gmail.com
    Contact for Scientific Queries Sorry, not currently available
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