Biomarkers of Change in BPD After Metacognitive Interpersonal Therapy-standard Approach (CLIMAMITHE)
Neuroimaging and Clinical Markers of Change in Borderline Personality Disorder After Metacognitive Interpersonal Therapy - Standard Approach
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brescia, Italy, 25125
- Irccs Centre San Giovanni di Dio - Fatebenefratelli
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Meet DSM 5 criteria for BPD
- Able to provide informed consent
Exclusion Criteria:
- lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, organic mental syndromes;
- active substance abuse or dependence in the 6 months before the enrolment;
- concurrent psychotherapy;
- cognitive impairment or dementia;
- relevant neurological signs;
- pregnancy/lactating.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: MIT - SA
Metacognitive Interpersonal Therapy -standard approach (MIT-SA) is a cognitive behavior-based psychotherapeutic approach that works to increase metacognitive abilities and to improve interpersonal relationships
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MIT-SA consists of weekly individual therapy (1 year) and weekly group sessions (six months)
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Active Comparator: Clinical Structured Treatment (CST)
Clinical Structured Treatment (CST) is a structured case management and symptom-targeted medication
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structured case management and symptom-targeted medication
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Difficulties in Emotion Regulation Scale (DERS)
Time Frame: 6, 12, 18 months
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Clinical changes in metacognitive abilities and in emotion regulation assessed with the Difficulties in Emotion Regulation Scale (DERS)
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6, 12, 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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changes in metacognitive abilities (assessed with the Metacognition Assessment Interview)
Time Frame: 6, 12, 18 months
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Clinical changes in metacognitive abilities assessed with the Metacognition Assessment Interview
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6, 12, 18 months
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Change from Baseline in activation in the amygdala at 12 months
Time Frame: 12 months
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Change from Baseline in activation in the amygdala at 12 months in response to standardized emotional material from the International Affective Pictures System
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12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Roberta Rossi, PsyD, IRCCS Centro San Giovanni di Dio - FBF
Publications and helpful links
General Publications
- Semerari A, Cucchi M, Dimaggio G, Cavadini D, Carcione A, Battelli V, Nicolo G, Pedone R, Siccardi T, D'Angerio S, Ronchi P, Maffei C, Smeraldi E. The development of the Metacognition Assessment interview: instrument description, factor structure and reliability in a non-clinical sample. Psychiatry Res. 2012 Dec 30;200(2-3):890-5. doi: 10.1016/j.psychres.2012.07.015. Epub 2012 Aug 18.
- Rossi R, Lanfredi M, Pievani M, Boccardi M, Rasser PE, Thompson PM, Cavedo E, Cotelli M, Rosini S, Beneduce R, Bignotti S, Magni LR, Rillosi L, Magnaldi S, Cobelli M, Rossi G, Frisoni GB. Abnormalities in cortical gray matter density in borderline personality disorder. Eur Psychiatry. 2015 Feb;30(2):221-7. doi: 10.1016/j.eurpsy.2014.11.009. Epub 2015 Jan 2.
- Rossi R, Pievani M, Lorenzi M, Boccardi M, Beneduce R, Bignotti S, Borsci G, Cotelli M, Giannakopoulos P, Magni LR, Rillosi L, Rosini S, Rossi G, Frisoni GB. Structural brain features of borderline personality and bipolar disorders. Psychiatry Res. 2013 Aug 30;213(2):83-91. doi: 10.1016/j.pscychresns.2012.07.002. Epub 2012 Nov 10.
- Rossi R, Lanfredi M, Pievani M, Boccardi M, Beneduce R, Rillosi L, Giannakopoulos P, Thompson PM, Rossi G, Frisoni GB. Volumetric and topographic differences in hippocampal subdivisions in borderline personality and bipolar disorders. Psychiatry Res. 2012 Aug-Sep;203(2-3):132-8. doi: 10.1016/j.pscychresns.2011.12.004. Epub 2012 Sep 1.
- Magni LR, Carcione A, Ferrari C, Semerari A, Riccardi I, Nicolo' G, Lanfredi M, Pedrini L, Cotelli M, Bocchio L, Pievani M, Gasparotti R, Rossi R; CLIMAMITHE Study group. Neurobiological and clinical effect of metacognitive interpersonal therapy vs structured clinical model: study protocol for a randomized controlled trial. BMC Psychiatry. 2019 Jun 24;19(1):195. doi: 10.1186/s12888-019-2127-2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GR-2011-02351347
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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