Borderline Personality DisorderCLIMAMITHENCT02370316
Biomarkers of Change in BPD After Metacognitive Interpersonal Therapy-standard Approach
A study testing Metacognitive Interpersonal Therapy (MIT-SA) and Clinical Structured Treatment in people with Borderline Personality Disorder, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Metacognitive Interpersonal Therapy (MIT-SA) and Clinical Structured Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2015to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meet DSM 5 criteria for BPD
- Able to provide informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuroimaging and Clinical Markers of Change in Borderline Personality Disorder After Metacognitive Interpersonal Therapy - Standard Approach
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.
Read the 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Metacognitive Interpersonal Therapy (MIT-SA), Clinical Structured Treatment
- Keywords
- metacognition, MRI, Psychotherapy
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Interpersonal Therapy (MIT-SA)Behavioural
MIT-SA consists of weekly individual therapy (1 year) and weekly group sessions (six months)
Clinical Structured TreatmentBehavioural
structured case management and symptom-targeted medication
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Clinical Structured Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6, 12, 18 months
Secondary outcomes (2)
changes in metacognitive abilities (assessed with the Metacognition Assessment Interview)
Clinical changes in metacognitive abilities assessed with the Metacognition Assessment Interview
Measured: 6, 12, 18 months
Change from Baseline in activation in the amygdala at 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startDec 2015
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Rossi, IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Investigators
- Roberta Rossi, PsyD, Principal investigator, IRCCS Centro San Giovanni di Dio - FBF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370316
- Sponsor's protocol ID
- GR-2011-02351347
- Acronym
- CLIMAMITHE
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2015
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22906953Rossi 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.
PubMed 25561291Rossi 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.
PubMed 23146251Rossi 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.
PubMed 22944368Quattrini 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.
PubMed 39454963Rossi 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.
PubMed 37227866Magni 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.
PubMed 31234864
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging and Clinical Markers of Change in Borderline Personality Disorder After Metacognitive Interpersonal Therapy - Standard Approach
- ClinicalTrials.gov ID
- NCT02370316
- Acronym / sponsor ID
- CLIMAMITHE / GR-2011-02351347
- Conditions
- Borderline Personality Disorder
- Keywords
- metacognition, MRI, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIT - SA | Experimental | Behavioral: Metacognitive Interpersonal Therapy (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 |
| Clinical Structured Treatment (CST) | Active comparator | Behavioral: Clinical Structured TreatmentClinical Structured Treatment (CST) is a structured case management and symptom-targeted medication |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Meet DSM 5 criteria for BPD
- Able to provide informed consent
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive Interpersonal Therapy (MIT-SA)MIT-SA consists of weekly individual therapy (1 year) and weekly group sessions (six months) | Behavioural | MIT - SA |
| Clinical Structured Treatmentstructured case management and symptom-targeted medication | Behavioural | Clinical Structured Treatment (CST) |
Primary outcome
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)
2 secondary outcomes
changes in metacognitive abilities (assessed with the Metacognition Assessment Interview)
Time frame: 6, 12, 18 months
Change from Baseline in activation in the amygdala at 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Background: PubMed 22906953Semerari 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.
- Background: PubMed 25561291Rossi 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.
- Background: PubMed 23146251Rossi 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.
- Background: PubMed 22944368Rossi 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.
- Derived from this study: PubMed 39454963Quattrini 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.
- Derived from this study: PubMed 37227866Rossi 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.
- Derived from this study: PubMed 31234864Magni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberta Rossi, PsyD principal investigator
IRCCS Centro San Giovanni di Dio - FBF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Interpersonal Therapy (MIT-SA) and Clinical Structured Treatment in people with Borderline Personality Disorder, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Difficulties in Emotion Regulation Scale (DERS) (time frame: 6, 12, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02370316, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.