Biomarkers of Change in BPD After Metacognitive Interpersonal Therapy-standard Approach
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      The present randomised clinical trial aims to assess the clinical and neurobiological changes
      following Metacognitive Interpersonal Therapy -standard approach (MIT-SA) compared with
      Clinical Structured Treatment (CST) derived from specific recommendations in APA guidelines
      for borderline personality disorder (BPD). The investigators will assess clinical changes in
      metacognitive abilities and in emotion regulation and changes in brain activation patterns at
      the resting state and while they view emotional pictures. A multidimensional assessment will
      be performed at the baseline, at 6, 12, 18 months. The investigators will take structural and
      functional Magnetic Resonance Images (MRIs) in MIT-Treated BPD (N=30) and CST-treated BPD
      (N=30) at baseline and after treatment, as well as a group of 30 healthy and unrelated
      volunteers that will be scanned once for comparison. Furthermore, blood analyses will be done
      in order to assess level of BDNF and some hormone levels (oxytocin and vasopressin) before
      and after treatments.
    

Detailed description: 
      Patients will be randomly allocate to two kind of interventions: MIT-SA and CST. Patients
      will be enrolled in 3 centres: Unit of Psychiatry, IRCCS San Giovanni di Dio-FBF, Brescia;
      Terzo Centro di Psicoterapia Cognitiva-School of Cognitive Psychotherapy, Rome; Mental Health
      Department ASL Roma G, Rome, Italy.

      A multidimensional evaluation with standardized tools will assess: level of psychopathology,
      depression, anger, impulsiveness, level of functioning. In particular, the assessment will
      include: the Structured Clinical Interview for DSM disorder; the Difficulties in Emotion
      Regulation Scale (DERS) (primary outcome); Metacognition Assessment Interview to assess
      metacognitive functions. Neuropsychological assessment will assess different cognitive
      domains, empathy and emotional recognition with standardized tools . Additionally, the
      emotional priming paradigm to evaluate emotion processing will be included.

      Data on demographics, traumatic exposure, suicide attempts, self-injury and aggression
      episodes, hospitalizations, and pharmacotherapy will be collected. Structural and functional
      MRI will be collected in MIT-Treated BPD (N=30) and CST-treated BPD (N=30) at baseline and
      after treatment. Healthy volunteers (N=30) will be scanned once for comparison. Specific MRI
      analyses:1) Whole brain (cortical thickness) analyses will be conducted to explore the
      correlates of psychotherapy and treatment response. Functional connectivity studies will
      consider A) activity at rest, both before and after treatment; B) functional activation in
      response to standardized emotional material from the International Affective Pictures System
      (IAPS). 2) Region of interest analyses: regions of particular elevance (hippocampus,
      amygdale, insula) will be studied using advanced neuroimaging tools.

      Blood samples will be collected in order to assess variations in levels of BDNF and some
      hormones (oxytocin and vasopressin) pre- and post treatment.
    

Intervention name(s): Metacognitive Interpersonal Therapy (MIT-SA); Clinical Structured Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MIT-SA consists of weekly individual therapy (1 year) and weekly group sessions (six months); structured case management and symptom-targeted medication
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: metacognition; MRI; Psychotherapy