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

Laura Rosa Magni, Antonino Carcione, Clarissa Ferrari, Antonio Semerari, Ilaria Riccardi, Giuseppe Nicolo', Mariangela Lanfredi, Laura Pedrini, Maria Cotelli, Luisella Bocchio, Michela Pievani, Roberto Gasparotti, Roberta Rossi, CLIMAMITHE Study group, Roberta Rossi, Laura Rosa Magni, Mariangela Lanfredi, Laura Pedrini, Antonino Carcione, Antonio Semerari, Ilaria Riccardi, Giuseppe Nicolo', Monica Almici, Rossella Beneduce, Genoveffa Borsci, Chiara Caprioli, Matteo Nodari, Antonio Vita, Stefano Barlati, Laura Laffranchini, Luciana Rillosi, Giuseppe Rossi, Luisella Bocchio, Anna Cattaneo, Nadia Cattane, Giovanni Battista Tura, Stefano Bignotti, Maddalena Speziali, Maria Cotelli, Sandra Rosini, Roberto Gasparotti, Claudia Ambrosi, Lorella Mascaro, Daniele Corbo, Michela Pievani, Giulia Quattrini, Elena Bilotta, Livia Colle, Laura Conti, Donatella Fiore, Alessandra Micheloni, Michele Procacci, Valentina Silvestre, Laura Rosa Magni, Antonino Carcione, Clarissa Ferrari, Antonio Semerari, Ilaria Riccardi, Giuseppe Nicolo', Mariangela Lanfredi, Laura Pedrini, Maria Cotelli, Luisella Bocchio, Michela Pievani, Roberto Gasparotti, Roberta Rossi, CLIMAMITHE Study group, Roberta Rossi, Laura Rosa Magni, Mariangela Lanfredi, Laura Pedrini, Antonino Carcione, Antonio Semerari, Ilaria Riccardi, Giuseppe Nicolo', Monica Almici, Rossella Beneduce, Genoveffa Borsci, Chiara Caprioli, Matteo Nodari, Antonio Vita, Stefano Barlati, Laura Laffranchini, Luciana Rillosi, Giuseppe Rossi, Luisella Bocchio, Anna Cattaneo, Nadia Cattane, Giovanni Battista Tura, Stefano Bignotti, Maddalena Speziali, Maria Cotelli, Sandra Rosini, Roberto Gasparotti, Claudia Ambrosi, Lorella Mascaro, Daniele Corbo, Michela Pievani, Giulia Quattrini, Elena Bilotta, Livia Colle, Laura Conti, Donatella Fiore, Alessandra Micheloni, Michele Procacci, Valentina Silvestre

Abstract

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.

Keywords: Borderline personality disorder; Emotion dysregulation; Metacognition; Neuroimaging; Psychotherapy.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study Flowchart. MIT: Metacognitive Interpersonal Therapy; SCM Structured Clinical Management

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