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Biomarkers of Change in BPD After Metacognitive Interpersonal Therapy-standard Approach

NCT02370316 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2020-02-13

No results posted yet for this study

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.

Conditions

  • Borderline Personality Disorder

Interventions

BEHAVIORAL

Metacognitive Interpersonal Therapy (MIT-SA)

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

BEHAVIORAL

Clinical Structured Treatment

structured case management and symptom-targeted medication

Sponsors & Collaborators

  • IRCCS Centro San Giovanni di Dio Fatebenefratelli

    lead OTHER

Principal Investigators

  • Roberta Rossi, PsyD · IRCCS Centro San Giovanni di Dio - FBF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02370316 on ClinicalTrials.gov