Trial Review

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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] 308572 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 328436 0
Condition category
Condition code
Mental Health 325462 325462 0 0
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] 325017 0
Treatment: Other
Intervention code [2] 325126 0
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] 333309 0
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] 333309 0
Recruited patients and control subjects will be evaluated at baseline (t0) and at 4 months post enrolment (t1).
Secondary outcome [1] 416580 0
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] 416580 0
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?
No
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
58
Final
Recruitment outside Australia
Country [1] 25170 0
Italy
State/province [1] 25170 0
Turin, Piedmont

Funding & Sponsors
Funding source category [1] 312820 0
University
Name [1] 312820 0
University of Turin
Country [1] 312820 0
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] 314463 0
None
Name [1] 314463 0
None
Address [1] 314463 0
None
Country [1] 314463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312100 0
University of Turin research ethics committee
Ethics committee address [1] 312100 0
SC Psichiatria U (Prof. Rocca), Dipartimento di Neuroscienze “Rita Levi Montalcini”, Università degli Studi di Torino, Torino, Via Cherasco 11
Ethics committee country [1] 312100 0
Italy
Date submitted for ethics approval [1] 312100 0
Approval date [1] 312100 0
20/04/2022
Ethics approval number [1] 312100 0

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 123474 0
Dr Paola Bozzatello
Address 123474 0
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 123474 0
Italy
Phone 123474 0
+390116703778
Fax 123474 0
Email 123474 0
paola.bozzatello@unito.it
Contact person for public queries
Name 123475 0
Dr Paola Bozzatello
Address 123475 0
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 123475 0
Italy
Phone 123475 0
+390116703778
Fax 123475 0
Email 123475 0
paola.bozzatello@unito.it
Contact person for scientific queries
Name 123476 0
Dr Paola Bozzatello
Address 123476 0
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 123476 0
Italy
Phone 123476 0
+390116703778
Fax 123476 0
Email 123476 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


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
EmbaseGroup interpersonal psychotherapy (IPT-G) for borderline personality disorder: A randomized controlled study.2023https://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.