ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000002684

Ethics application status

Approved

Date submitted

6/12/2022

Date registered

9/01/2023

Date last updated

28/01/2024

Date data sharing statement initially provided

9/01/2023

Type of registration

Retrospectively registered

Titles & IDs

Public title

Group psychotherapy in patients with borderline personality disorder: experimental contribution in an outpatient setting

Scientific title

Group psychotherapy in patients with borderline personality disorder: investigating the effect on symptoms when delivered in an outpatient setting

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

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

The aim of the trial is to evaluate the effectiveness of interpersonal group psychotherapy in patients with Borderline Personality Disorder (BPD) on the main symptom clusters of the disorder, anxiety and depressive symptoms, global functioning and quality of life.
The interpersonal group psychotherapeutic approach will be compared with individual interpersonal psychotherapy alone.
Interventions:
1) 20 minute one-on-one interview with the registered psychiatrist for the presentation of the project, 2 week prior to the first group session;
2) 16 interpersonal group psychotherapy meetings lasting 60 minutes delivered once a week; sessions include a first part in which participants take turns exposing the most important events of the past week. In the second part, they decide which situation to analyze collectively. the maximum number of participants who may attend a group session is 10 participants together with the psychiatrist, psychologist and two residents. To monitor treatment adherence, a satisfaction questionnaire is administered at the end of each session.
3) 90-minute clinical interviews with administration of psychometric scales at (t0 and t1).
The sessions will be held by a psychiatrist, in the presence of a psychologist and two residents.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

Control group: patients known to the outpatient clinic, with a diagnosis of Borderline Personality Disorder (BPD) according to DSM-5 criteria, who receive individual interpersonal psychotherapy and are on the waiting list for Interpersonal Psychotherapy- Group (IPT-G).
Participants in the control group will receive 10 months of therapy divided into two phases of 22 sessions (20 weeks) + 20 sessions (20 weeks). The 50-minute sessions are weekly.

Control group

Active

Outcomes

Primary outcome [1]

To assess the effectiveness of interpersonal group psychotherapy in patients with Borderline Personality Disorder (BPD). The core symptoms of the disorder, aggression, anxiety and depressive symptoms, relational style and interpersonal functioning, social and global functioning and quality of life will be investigated by comparing the interpersonal group psychotherapeutic approach with individual interpersonal psychotherapy alone. symptoms will be assessed as a composite primary outcome administering psychometric scales. The scales selected are; Childhood Trauma Questionnaire Short Form (CTQ-SF) for remote antecedents assessment; Borderline Personality Disorder Severity Index (BDPSI); Barratt Impulsivity scale II (BIS II), Modified Overt Aggression Scale (MOAS), Self Harm Inventory; Inventory of Interpersonal Problems (IIP-32), Reading the Mind in the Eyes fot assessment of core symptoms of the disorder; Satisfaction Profile to assess functioning and quality of life.

Timepoint [1]

Recruited patients and control subjects will be evaluated at baseline (t0) and at 4 months post enrolment (t1).

Secondary outcome [1]

To assess the patient's personal experience and satisfaction with the therapeutic relationship and interaction with other members experienced in the group context. These outcome will be assessed together using the Group Questionnaire (GQ)

Timepoint [1]

Recruited patients and control subjects will be evaluated at baseline (t0) and at 4 months post-enrolment (t1).

Eligibility

Key inclusion criteria

Consecutive (18-60 years), outpatients with a diagnosis of DBP according to DSM-5 criteria will be enrolled. The diagnosis is made by evaluation by experienced clinicians and by administration of SCID-5 (Structured Clinical Interview for DSM-5 personality disorders). The patients in this group are undergoing individual interpersonal psychotherapy, which will be supported by IPT-G intervention.

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

a) presence of neuropsychiatric comorbidities, assessed according to DSM-5 criteria and including: neurodevelopmental disorders; neurocognitive disorders; schizophrenia and schizophrenic spectrum disorders; bipolar disorder
b) concomitant major depressive episode and/or active substance use;
c) symptomatological severity judged by the clinician to be incompatible with adaptation to the group setting.

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

22/04/2022

Date of last participant enrolment

Anticipated

22/04/2025

Actual

Date of last data collection

Anticipated

30/09/2025

Actual

Sample size

Target

120

Accrual to date

Final

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Turin, Piedmont

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Turin

Address [1]

SC Psichiatria U, Dipartimento di Neuroscienze “Rita Levi Montalcini”, Università degli Studi di Torino, Via Cherasco 11, Torino

Country [1]

Italy

Primary sponsor type

University

Name

University of Turin

Address

SC Psichiatria U, Dipartimento di Neuroscienze “Rita Levi Montalcini”, Università degli Studi di Torino, Via Cherasco 11, Torino

Country

Italy

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Turin research ethics committee

Ethics committee address [1]

SC Psichiatria U (Prof. Rocca), Dipartimento di Neuroscienze “Rita Levi Montalcini”, Università degli Studi di Torino, Torino, Via Cherasco 11

Ethics committee country [1]

Italy

Date submitted for ethics approval [1]

Approval date [1]

20/04/2022

Ethics approval number [1]

Summary

Brief summary

Psychotherapy appears to be the pivotal treatment for patients with DBP. In particular, the interpersonal psychotherapeutic approach appears particularly suitable for this type of patient because it acts on the dysfunctional relational patterns that represent the core of the disorder. The group approach can be an opportunity for the borderline patient to experience his or her own relational dynamics in a protected environment; it allows patients to realise that others share their illness; it facilitates self-reflection and understanding of how certain behaviours provoke particular reactions; it gives the possibility of directly testing certain changes within the group and receiving in return support and stimulation in bringing these changes into one's relational life, of feeling gratified when helping other group members. At the same time, the group context offers therapists the possibility of treating a larger number of patients simultaneously while optimising costs and time. As the current literature on IPT-G in DBP is scarce, the results of this study could provide useful new evidence and inspire the launch of an outpatient project to be shared with other clinics, both hospital and territorial.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Paola Bozzatello

Address

SC Psichiatria U (Prof. Rocca), Dipartimento di Neuroscienze e Salute Mentale, AOU Città della Salute e della Scienza di Torino, Via Cherasco 11, Torino

Country

Italy

Phone

+390116703778

Fax

paola.bozzatello@unito.it

Contact person for public queries

Name

Paola Bozzatello

Address

SC Psichiatria U (Prof. Rocca), Dipartimento di Neuroscienze e Salute Mentale, AOU Città della Salute e della Scienza di Torino, Via Cherasco 11, Torino

Country

Italy

Phone

+390116703778

Fax

paola.bozzatello@unito.it

Contact person for scientific queries

Name

Paola Bozzatello

Address

SC Psichiatria U (Prof. Rocca), Dipartimento di Neuroscienze e Salute Mentale, AOU Città della Salute e della Scienza di Torino, Via Cherasco 11, Torino

Country

Italy

Phone

+390116703778

Fax

paola.bozzatello@unito.it

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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	Group interpersonal psychotherapy (IPT-G) for borderline personality disorder: A randomized controlled study.	2023	https://dx.doi.org/10.1016/j.jpsychires.2023.10.049

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

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