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

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ClinicalTrials.gov Identifier: NCT02370316
Recruitment Status : Active, not recruiting
First Posted : February 24, 2015
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Roberta Rossi, IRCCS Centro San Giovanni di Dio Fatebenefratelli

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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Behavioral: Metacognitive Interpersonal Therapy (MIT-SA) Behavioral: Clinical Structured Treatment Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuroimaging and Clinical Markers of Change in Borderline Personality Disorder After Metacognitive Interpersonal Therapy - Standard Approach
Actual Study Start Date : December 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Behavioral: Metacognitive Interpersonal Therapy (MIT-SA)
MIT-SA consists of weekly individual therapy (1 year) and weekly group sessions (six months)

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




Primary Outcome Measures :
  1. Change in Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 6, 12, 18 months ]
    Clinical changes in metacognitive abilities and in emotion regulation assessed with the Difficulties in Emotion Regulation Scale (DERS)


Secondary Outcome Measures :
  1. changes in metacognitive abilities (assessed with the Metacognition Assessment Interview) [ Time Frame: 6, 12, 18 months ]
    Clinical changes in metacognitive abilities assessed with the Metacognition Assessment Interview

  2. Change from Baseline in activation in the amygdala at 12 months [ Time Frame: 12 months ]
    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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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370316


Locations
Italy
Irccs Centre San Giovanni di Dio - Fatebenefratelli
Brescia, Italy, 25125
Sponsors and Collaborators
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Investigators
Principal Investigator: Roberta Rossi, PsyD IRCCS Centro San Giovanni di Dio - FBF

Publications:
Responsible Party: Roberta Rossi, psyD, IRCCS Centro San Giovanni di Dio Fatebenefratelli
ClinicalTrials.gov Identifier: NCT02370316     History of Changes
Other Study ID Numbers: GR-2011-02351347
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roberta Rossi, IRCCS Centro San Giovanni di Dio Fatebenefratelli:
metacognition
MRI
Psychotherapy

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders