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Open Access 01-12-2019 | Psychotherapy | Study protocol

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

Authors: 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

Published in: BMC Psychiatry | Issue 1/2019

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.

Available only for authorised users

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Title: Neurobiological and clinical effect of metacognitive interpersonal therapy vs structured clinical model: study protocol for a randomized controlled trial
Authors: 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
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: Psychotherapy
Borderline Personality Disorder
Published in: BMC Psychiatry / Issue 1/2019
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/s12888-019-2127-2

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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