Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000326594
Ethics application status
Approved
Date submitted
13/12/2023
Date registered
25/03/2024
Date last updated
25/03/2024
Date data sharing statement initially provided
25/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Interpersonal Counselling for family members of Borderline Personality Disorder patients: experimental contribution in an outpatient setting.
Scientific title
A study investigating the role for interpersonal counselling in psychological symptom management amongst family members of Borderline Personality Disorder patients.
Secondary ID [1] 311142 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 332308 0
Condition category
Condition code
Mental Health 329018 329018 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions:
1) 6 interpersonal counselling meetings lasting 60 minutes delivered once a fortnight. The meetings are aimed at a relative cohabitant of BPD patient. The sessions will be held by a psychiatrist. Goals and techniques used in these meetings will follow the standardized Revised Interpersonal Psychotherapy adapted for treating Borderline Personality Disorder (IPT-BPD-R) model for the entire duration of the intervention. The meetings take place after outpatient access and registration in the secretariat in the form of individual psychotherapy.
2) 90-minute clinical interviews with administration of psychometric scales at t0 and t1, i.e. before the start and after the conclusion of the intervention.
The sessions will be held face-to-face by a psychiatrist, in the presence of a psychologist.
3) 90-minute clinical interviews for BPD patients, with administration of psychometric scales at t0 and t1, i.e. before the start and after the conclusion of the intervention.
The sessions will be held face-to-face by a psychiatrist, in the presence of a psychologist.
Intervention code [1] 327586 0
Treatment: Other
Intervention code [2] 327587 0
Behaviour
Comparator / control treatment
1) No intervention is proposed to relatives, who remain on the waiting list.
2) 90-minute clinical interviews with administration of psychometric scales at t0 and t1 3 months later.
The sessions will be held face-to-face by a psychiatrist, in the presence of a psychologist.
3) 90-minute clinical interviews for BPD patients, with administration of psychometric scales at t0 and t1 3 months later.
The sessions will be held face-to-face by a psychiatrist, in the presence of a psychologist.
Control group
Active

Outcomes
Primary outcome [1] 336814 0
To assess the effectiveness of interpersonal counselling in family members of BPD patients. The general symptoms, anxiety, depressive symptoms, global functioning, quality of life and perceived stress, will be investigated by comparing the interpersonal counselling approach with no treatment. Symptoms will be assessed as a composite primary outcome administering psychometric scales.
Timepoint [1] 336814 0
Recruited relatives and control subjects will be evaluated at baseline (t0) and at 3 months post enrolment (t1).
Secondary outcome [1] 429745 0
To assess the efficacy of IPC on BPD symptoms of patients whose relatives received IPC.
Timepoint [1] 429745 0
Recruited patients and control subjects will be evaluated at baseline (t0) and at 3 months post enrolment (t1).

Eligibility
Key inclusion criteria
Consecutive (20-75 years), family members of patients diagnosed with BPD 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 inclusion criteria for patients require a diagnosis made by evaluation by experienced clinicians and by administration of SCID-5 (Structured Clinical Interview for DSM-5 personality disorders).
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for relatives:
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) A personality disorder that emerged at the SCID-5-PD interview.

Exclusion criteria for patients:
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 setting.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Efficacy
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
100
Accrual to date
48
Final
Recruitment outside Australia
Country [1] 26022 0
Italy
State/province [1] 26022 0

Funding & Sponsors
Funding source category [1] 315397 0
University
Name [1] 315397 0
University of Turin (UniTo)
Country [1] 315397 0
Italy
Primary sponsor type
University
Name
University of Turin (UniTo)
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] 317460 0
None
Name [1] 317460 0
Address [1] 317460 0
Country [1] 317460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314315 0
University of Turin research ethics committee
Ethics committee address [1] 314315 0
University Bioethics Committee, University of Turin (UniTo). Via Bogino, 9 - 10123 Torino.
Ethics committee country [1] 314315 0
Italy
Date submitted for ethics approval [1] 314315 0
Approval date [1] 314315 0
20/04/2022
Ethics approval number [1] 314315 0

Summary
Brief summary
Borderline personality disorder represents an important challenge for clinicians and family members. It is known that relatives are frequently involved in patients’ crisis and find themselves in need of handling them. It is also well estabilished that family members of BPD patients can show psychiatric conditions that may play an important role on BPD’s progress. For these reasons an interpersonal psychotherapeutic approach appears particularly suitable in form of Interpersonal Councelling because it acts on the dysfunctional relational patterns.
Interpersonal counselling shares a double purpose: a) acting on patient’s relatives psychiatric symptoms, global functioning, quality of life and perceived stress; b) acting through relatives, modifying the interpersonal relationship with the patient itself in order to offer him a more adaptative model he may adopt as a model for other interpersonal relationships.
As the current literature on a IPT-based counselling 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.
The hypothesis of our study is that an intervention aimed at the relatives of BPD patients can lead to clinical benefit for both the patient as well as the family.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131154 0
Prof Paola Bozzatello
Address 131154 0
SC Psichiatria U (Prof. Rocca), Dipartimento di Neuroscienze e Salute Mentale, AOU Città della Salute e della Scienza di Torino, Via Cherasco 11, postcode: 10126, Torino
Country 131154 0
Italy
Phone 131154 0
+390116703778
Fax 131154 0
Email 131154 0
paola.bozzatello@unito.it
Contact person for public queries
Name 131155 0
Prof Paola Bozzatello
Address 131155 0
SC Psichiatria U (Prof. Rocca), Dipartimento di Neuroscienze e Salute Mentale, AOU Città della Salute e della Scienza di Torino, Via Cherasco 11, postcode: 10126, Torino
Country 131155 0
Italy
Phone 131155 0
+390116703778
Fax 131155 0
Email 131155 0
paola.bozzatello@unito.it
Contact person for scientific queries
Name 131156 0
Prof Paola Bozzatello
Address 131156 0
SC Psichiatria U (Prof. Rocca), Dipartimento di Neuroscienze e Salute Mentale, AOU Città della Salute e della Scienza di Torino, Via Cherasco 11, postcode: 10126, Torino
Country 131156 0
Italy
Phone 131156 0
+390116703778
Fax 131156 0
Email 131156 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
No additional documents have been identified.