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
|Condition or disease||Intervention/treatment||Phase|
|Borderline Personality Disorder||Behavioral: Metacognitive Interpersonal Therapy (MIT-SA) Behavioral: Clinical Structured Treatment||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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)
- 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
- 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
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
|Irccs Centre San Giovanni di Dio - Fatebenefratelli|
|Brescia, Italy, 25125|
|Principal Investigator:||Roberta Rossi, PsyD||IRCCS Centro San Giovanni di Dio - FBF|