Neurobiological and clinical effect of metacognitive interpersonal therapy vs structured clinical model: Study protocol for a randomized controlled trial

L.R. Magni, A. Carcione, C. Ferrari, A. Semerari, I. Riccardi, G. Nicolo, M. Lanfredi, L. Pedrini, M. Cotelli, L. Bocchio, M. Pievani, R. Gasparotti, R. Rossi, M. Almici, R. Beneduce, G. Borsci, C. Caprioli, M. Nodari, A. Vita, S. BarlatiL. Laffranchini, L. Rillosi, G. Rossi, A. Cattaneo, N. Cattane, G.B. Tura, S. Bignotti, M. Speziali, S. Rosini, C. Ambrosi, L. Mascaro, D. Corbo, G. Quattrini, E. Bilotta, L. Colle, L. Conti, D. Fiore, A. Micheloni, M. Procacci, V. Silvestre

Research output: Contribution to journalArticlepeer-review


Background: Borderline Personality Disorder (BPD) is a complex and debilitating disorder, characterized by deficits in metacognition and emotion dysregulation. The "gold standard" treatment for this disorder is psychotherapy with pharmacotherapy as an adjunctive treatment to target state symptoms. The present randomized clinical trial aims to assess the clinical and neurobiological changes following Metacognitive Interpersonal Therapy (MIT) compared with Structured Clinical Management (SCM) derived from specific recommendations in APA (American Psychiatric Association) guidelines for BPD. Methods: The study design is a randomized parallel controlled clinical trial and will include 80 BPD outpatients, aged 18-45 enrolled at 2 recruitment centers. Primary outcome will be the clinical change in emotion regulation capacities assessed with the Difficulties in Emotion Regulation Scale (DERS). We will also investigated the effect of psychotherapy on metacognitive abilities and several clinical features such as BPD symptomatology, general psychopathology, depression, personal functioning, and trait dimensions (anger, impulsivity, alexithymia). We will evaluate changes in brain connectivity patterns and during the view of emotional pictures. A multidimensional assessment will be performed at the baseline, at 6, 12, 18 months. We will obtain structural and functional Magnetic Resonance Images (MRIs) in MIT-Treated BPD (N = 30) and SCM-treated BPD (N = 30) at baseline and after treatment, as well as in a group of 30 healthy and unrelated volunteers that will be scanned once for comparison. Discussion: The present study could contribute to elucidate the neurobiological mechanisms underlying psychotherapy efficacy. The inclusion of a multidisciplinary study protocol will allow to study BPD considering different features that can affect the treatment response and their reciprocal relationships. Trial registration: NCT02370316. Registered 02/24/2015. © 2019 The Author(s).
Original languageEnglish
Article number195
JournalBMC Psychiatry
Issue number1
Publication statusPublished - 2019


  • Borderline personality disorder
  • Emotion dysregulation
  • Metacognition
  • Neuroimaging
  • Psychotherapy
  • adult
  • Article
  • behavior change
  • borderline state
  • clinical assessment
  • clinical feature
  • clinical outcome
  • cognitive behavioral therapy
  • controlled study
  • depression
  • Difficulties in Emotion Regulation Scale
  • emotion assessment
  • emotionality
  • female
  • functional connectivity
  • functional magnetic resonance imaging
  • functional neuroimaging
  • human
  • intermethod comparison
  • longitudinal study
  • major clinical study
  • male
  • metacognition
  • metacognitive interpersonal therapy
  • practice guideline
  • randomized controlled trial
  • social interaction
  • structured clinical management
  • therapy effect
  • treatment response


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