NCT02370316

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

2.9 years

First QC Date

February 10, 2015

Last Update Submit

February 12, 2020

Conditions

Borderline Personality Disorder

Keywords

metacognitionMRIPsychotherapy

Outcome Measures

Primary Outcomes (1)

  • Change in Difficulties in Emotion Regulation Scale (DERS)

    Clinical changes in metacognitive abilities and in emotion regulation assessed with the Difficulties in Emotion Regulation Scale (DERS)

    6, 12, 18 months

Secondary Outcomes (2)

  • changes in metacognitive abilities (assessed with the Metacognition Assessment Interview)

    6, 12, 18 months

  • Change from Baseline in activation in the amygdala at 12 months

    12 months

Study Arms (2)

MIT - SA

EXPERIMENTAL

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

Behavioral: Metacognitive Interpersonal Therapy (MIT-SA)

Clinical Structured Treatment (CST)

ACTIVE COMPARATOR

Clinical Structured Treatment (CST) is a structured case management and symptom-targeted medication

Behavioral: Clinical Structured Treatment

Interventions

Metacognitive Interpersonal Therapy (MIT-SA)BEHAVIORAL

MIT-SA consists of weekly individual therapy (1 year) and weekly group sessions (six months)

MIT - SA
Clinical Structured TreatmentBEHAVIORAL

structured case management and symptom-targeted medication

Clinical Structured Treatment (CST)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Meet DSM 5 criteria for BPD
  • Able to provide informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs Centre San Giovanni di Dio - Fatebenefratelli

Brescia, 25125, Italy

Location

Related Publications (7)

  • 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.

    PMID: 22906953BACKGROUND

  • 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.

    PMID: 25561291BACKGROUND

  • 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.

    PMID: 23146251BACKGROUND

  • 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.

    PMID: 22944368BACKGROUND

  • Quattrini G, Carcione A, Lanfredi M, Nicolo G, Pedrini L, Corbo D, Magni LR, Geviti A, Ferrari C, Gasparotti R, Semerari A, Pievani M, Rossi R. Effect of metacognitive interpersonal therapy on brain structural connectivity in borderline personality disorder: Results from the CLIMAMITHE randomized clinical trial. J Affect Disord. 2025 Jan 15;369:1145-1152. doi: 10.1016/j.jad.2024.10.107. Epub 2024 Oct 23.

    PMID: 39454963DERIVED

  • Rossi R, Corbo D, Magni LR, Pievani M, Nicolo G, Semerari A, Quattrini G, Riccardi I, Colle L, Conti L, Gasparotti R, Macis A, Ferrari C, Carcione A; CLIMAMITHE study group. Metacognitive interpersonal therapy in borderline personality disorder: Clinical and neuroimaging outcomes from the CLIMAMITHE study-A randomized clinical trial. Personal Disord. 2023 Jul;14(4):452-466. doi: 10.1037/per0000621. Epub 2023 May 25.

    PMID: 37227866DERIVED

  • 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.

    PMID: 31234864DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Officials

  • Roberta Rossi, PsyD

    IRCCS Centro San Giovanni di Dio - FBF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
psyD

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 24, 2015

Study Start

December 1, 2015

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

February 13, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)