ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

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]

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]

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]

At baseline (T0) and after 40 weeks

Secondary outcome [1]

Level of identity integration measured with the Identity disturbance questionnaire (IDQ) score

Timepoint [1]

At baseline (T0) and after 40 weeks

Secondary outcome [2]

Specific BPD symptoms assessed with the Borderline Personality Disorder Severity Index (BPDSI) score

Timepoint [2]

At baseline (T0) and after 40 weeks

Secondary outcome [3]

Changes in the Barratt Impulsiveness Scale -Version 11 (BIS-11)score

Timepoint [3]

At baseline (T0) and after 40 weeks

Secondary outcome [4]

Frequency of self-injuries measured with the Changes in the Self-Harm Inventory (SHI) score

Timepoint [4]

At baseline (T0) and after 40 weeks

Secondary outcome [5]

Aggressive Behaviors assessed with the Modified Overt Aggression Scale (MOAS) score

Timepoint [5]

At baseline (T0) and after 40 weeks

Secondary outcome [6]

Global symptoms measured with the Clinical Global Impression- Severity (CGI-S) scale.

Timepoint [6]

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]

Italy

State/province [1]

Turin

Funding & Sponsors

Funding source category [1]

University

Name [1]

Department of Neuroscience, University of Turin

Address [1]

Via Cherasco 15, 10126 Turin, Italy

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

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]

Corso Bramante 88, 10126, Turin (Italy)

Ethics committee country [1]

Italy

Date submitted for ethics approval [1]

02/07/2015

Approval date [1]

30/09/2015

Ethics approval number [1]

0094867(b)

Summary

Brief summary

In our previous study we investigated by fMRI which are the differences of brain activation between BPD patients with a low level of identity integration and healthy controls during a task of autobiographical memory. Based on the recent findings about neural correlates involved in patients with BPD during autobiographical memories we analyze the hemodynamic response in some regions of interest (ROIs). We hypothesized that BPD patients with a deficit in identity integration may present a higher brain activation in dorsolateral prefrontal cortex, insula, anterior cingulate cortex, and temporal parietal junction  during the recall of significant life events, both resolved and unresolved, in comparison with controls. In the present study BPD patients who have participated to the previous study are randomly assigned  to (1) interpersonal psychotherapy adapted for BPD-R (IPT-BPD-R) or (2) waiting list+clinical management for 40 weeks. All subjects (BPD patients and healthy controls) have fMRI at baseline and will repeat fMRI with the same task after 40 weeks. We will compare the changes in brain functioning in the ROIs (dorsolateral prefrontal cortex, insula, anterior cingulate cortex, and temporal parietal Junction) in the three groups (BPD patients who receive IPT-BPD-R; BPD patients who receive clinical management; and healthy subjects) after 40 weeks. We hypothesize that patients who receive psychotherapy will show a decrease of activity in the regions of interest in comparison with patients in waiting list who receive usual clinical management.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Silvio Bellino

Address

Department of Neuroscience, University of Turin, Via Cherasco 11., 10126 Turin, Italy

Country

Italy

Phone

+39 0116335425

Fax

+ 39 0116335425

Email

[email protected]

Contact person for public queries

Name

Paola Bozzatello

Address

Department of Neuroscience, University of Turin, Via Cherasco 11, 10126, Turin, Italy.

Country

Italy

Phone

+ 39 0116335425

Fax

+39 0116335425

Email

[email protected]

Contact person for scientific queries

Name

Paola Bozzatello

Address

Department of Neuroscience, University of Turin, Via Cherasco 11., 10126, Turin, Italy

Country

Italy

Phone

+ 39 0116335425

Fax

+ 39 0116335425

Email

[email protected]

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

Source	Title	Year of Publication	DOI
Embase	How Interpersonal Psychotherapy Changes the Brain: A Study of fMRI in Borderline Personality Disorder.	2022	https://dx.doi.org/10.4088/JCP.21m13918
Embase	The Role of Cognitive Deficits in Borderline Personality Disorder with Early Traumas: A Mediation Analysis.	2023	https://dx.doi.org/10.3390/jcm12030787

N.B. These documents automatically identified may not have been verified by the study sponsor.