Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000078156
Ethics application status
Approved
Date submitted
29/09/2017
Date registered
21/01/2019
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of psychotherapy on brain activity in patients with borderline personality disorder in comparison with controls: a functional magnetic resonance study.
Scientific title
Effects of interpersonal psychotherapy on brain functioning in patients with borderline personality disorder (BPD) compared with controls: a functional magnetic resonance (fMRI) study.
Secondary ID [1] 292654 0
None
Universal Trial Number (UTN)
U1111-1200-6918
Trial acronym
Linked study record
This study is a follow- on from the previous investigation: ACTRN12616000149460

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 304387 0
Condition category
Condition code
Mental Health 303721 303721 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psychotherapy: interpersonal psychotherapy adapted to borderline personality disorder, revised (IPT-BPD-R), consisting of 40 weeks (1 hour sessions/week). This intervention consists of individual sessions of psychotherapy focused on four main problematic areas: interpersonal contrasts; role transition; grief; and interpersonal deficit. Two phone calls (max 10 minutes) per week are allowed to handle crisis. These sessions are provided at the Psychiatric Clinic of the Hospital by a expert therapist of interpersonal psychotherapy.
If patient skips two consecutive sessions the intervention is stopped (and patient is considered as a drop-out).
Intervention code [1] 298888 0
Treatment: Other
Comparator / control treatment
Control treatment: waiting list (clinical monitoring with 1 visit/month). After 10 months patients in waiting list will receive psychotherapeutic intervention or combined therapy with psychotherapy and drugs.
Healthy subjects do not receive interventions.
Control group
Active

Outcomes
Primary outcome [1] 303522 0
As in the previous study registered in ANZCTR, primary outcome was brain functioning changes during the fMRI in the regions of interest (dorsolateral prefrontal cortex, insula, anterior cingulate cortex, and temporal parietal Junction) during the recall of significant life events.These data will be inserted into the Statistical Parametrical Mapping (SPM), a specific program to elaborate fMRI data.
Timepoint [1] 303522 0
At baseline (T0) and after 40 weeks
Secondary outcome [1] 339186 0
Level of identity integration measured with the Identity disturbance questionnaire (IDQ) score
Timepoint [1] 339186 0
At baseline (T0) and after 40 weeks
Secondary outcome [2] 339187 0
Specific BPD symptoms assessed with the Borderline Personality Disorder Severity Index (BPDSI) score
Timepoint [2] 339187 0
At baseline (T0) and after 40 weeks
Secondary outcome [3] 339188 0
Changes in the Barratt Impulsiveness Scale -Version 11 (BIS-11)score
Timepoint [3] 339188 0
At baseline (T0) and after 40 weeks
Secondary outcome [4] 339189 0
Frequency of self-injuries measured with the Changes in the Self-Harm Inventory (SHI) score
Timepoint [4] 339189 0
At baseline (T0) and after 40 weeks
Secondary outcome [5] 339190 0
Aggressive Behaviors assessed with the Modified Overt Aggression Scale (MOAS) score
Timepoint [5] 339190 0
At baseline (T0) and after 40 weeks
Secondary outcome [6] 339191 0
Global symptoms measured with the Clinical Global Impression- Severity (CGI-S) scale.
Timepoint [6] 339191 0
At baseline (T0) and after 40 weeks

Eligibility
Key inclusion criteria
Subjects included in the study have all right handed dominance (assessed with the Edinburgh Handedness Inventory. Diagnosis of borderline personality disorder (BPD) is made by an expert clinician and is confirmed with the Structured Clinical Interview for DSM.IV AxisII Disorders. Healthy subjects are recruited among general population, and are matched for age and gender.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria are: diagnoses of dementia, delirium, and other cognitive disorders; neurological diseases; schizophrenia and other psychotic disorders; bipolar disorders; concurrent major depressive episode; substance abuse in the last two months; pharmacological treatments in the last 3 weeks. Female patients of childbearing age were excluded if they were not using adequate birth control methods (according to the judgment of clinicians).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
At least 20 subjects for each groups should be enrolled.
Functional and structural images will be analyzed using Statistical Parametric Mapping 8 (SPM8, Wellcome Department of Cognitive Neurology, London, UK) implemented in Matlab (Mathworks, Cherborn, MA, USA).
Full factorial within-group analysis and full factorial between-groups analysis will be performed, BPD patients who receive IPT-BPD-R, versus BPD patients who receive clinical management, versus healthy controls.
Changes in clinical rating scales scores between baseline and 40 weeks will be analyzed with ANOVA.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
31
Final
Recruitment outside Australia
Country [1] 9245 0
Italy
State/province [1] 9245 0
Turin

Funding & Sponsors
Funding source category [1] 297288 0
University
Name [1] 297288 0
Department of Neuroscience, University of Turin
Country [1] 297288 0
Italy
Primary sponsor type
University
Name
Department of Neuroscience, University of Turin
Address
Via Cherasco 15, 10126 Turin, Italy
Country
Italy
Secondary sponsor category [1] 296670 0
None
Name [1] 296670 0
Address [1] 296670 0
Country [1] 296670 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298398 0
Comitato Etico Interaziendale A.O.U. Città della Salute e della Scienza di Torino - A.O. Ordine Mauriziano - A.S.L. Città di Torino
Ethics committee address [1] 298398 0
Ethics committee country [1] 298398 0
Italy
Date submitted for ethics approval [1] 298398 0
02/07/2015
Approval date [1] 298398 0
30/09/2015
Ethics approval number [1] 298398 0
0094867(b)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76954 0
Prof Silvio Bellino
Address 76954 0
Department of Neuroscience, University of Turin, Via Cherasco 11., 10126 Turin, Italy
Country 76954 0
Italy
Phone 76954 0
+39 0116335425
Fax 76954 0
+ 39 0116335425
Email 76954 0
silvio.bellino@unito.it
Contact person for public queries
Name 76955 0
Paola Bozzatello
Address 76955 0
Department of Neuroscience, University of Turin, Via Cherasco 11, 10126, Turin, Italy.
Country 76955 0
Italy
Phone 76955 0
+ 39 0116335425
Fax 76955 0
+39 0116335425
Email 76955 0
paola.bozzatello@unito.it
Contact person for scientific queries
Name 76956 0
Paola Bozzatello
Address 76956 0
Department of Neuroscience, University of Turin, Via Cherasco 11., 10126, Turin, Italy
Country 76956 0
Italy
Phone 76956 0
+ 39 0116335425
Fax 76956 0
+ 39 0116335425
Email 76956 0
paola.bozzatello@unito.it

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Our Ethics Committee does not allow.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHow Interpersonal Psychotherapy Changes the Brain: A Study of fMRI in Borderline Personality Disorder.2022https://dx.doi.org/10.4088/JCP.21m13918
EmbaseThe Role of Cognitive Deficits in Borderline Personality Disorder with Early Traumas: A Mediation Analysis.2023https://dx.doi.org/10.3390/jcm12030787
N.B. These documents automatically identified may not have been verified by the study sponsor.