Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001452583
Ethics application status
Approved
Date submitted
30/10/2024
Date registered
13/12/2024
Date last updated
13/12/2024
Date data sharing statement initially provided
13/12/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Borderline Personality Disorder and Substance Use Disorder: A Clinical Investigation
Scientific title
A study aimed to compare clinical and demographic factors between patients with Borderline Personality Disorder (BPD) with and without Substance Use Disorder (SUD) and to identify predictors of SUD severity within the BPD-SUD group.
Secondary ID [1] 313278 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 335600 0
Substance Use Disorder 335601 0
Condition category
Condition code
Mental Health 332167 332167 0 0
Psychosis and personality disorders
Mental Health 332168 332168 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No experimental pharmacological treatment is planned.
No experimental device is included.

The study involves the patient participating in a clinical interview to assess inclusion and exclusion criteria, followed by an interview to introduce the project. After completing the medical history collection, psychometric scales will be administered to evaluate core symptoms of the disorder, aggressiveness, anxiety and depressive symptoms, borderline symptomatology, substance use disorder symptomatology, quality of life, and overall functioning.
An initial outpatient interview will be scheduled to present the project and evaluate the aforementioned parameters, lasting approximately 60 minutes. Subsequent outpatient sessions will then be arranged for the administration of various psychometric scales, with each session lasting approximately 100 minutes (approximately 10 minutes per test - psychometric scale).

Clinical data will be collected using specific psychometric scales, including
Initial outpatient interview (60 minutes)
MCMI-III – Millon Clinical Multiaxial Inventory III (10 minutes)
SCID-5 – Structured Clinical Interview for DSM-5 Personality Disorders (30 minutes)
Subsequent outpatient session (100 minutes)
BPDSI – Borderline Personality Disorder Severity Index (10 minutes)
BIS-11 – Barratt Impulsivity Scale (10 minutes)
TAS-20 – Toronto Alexithymia Scale – 20 (10 minutes)
CISS – Coping Inventory for Stressful Situations (10 minutes)
CTQ-SF – Childhood Trauma Questionnaire – Short Form (10 minutes)
ABQ – Addictive Behavior Questionnaire (10 minutes)
SAT-P – Satisfaction Profile (10 minutes)
SOFAS – Social and Occupational Functioning Assessment Scale (10 minutes).

The assessment through testing will be conducted in a single session. This session will be preceded by an introductory meeting to analyze inclusion and exclusion criteria (including the verification of the BPD diagnosis using MCMI-III and SCID-5) and to present the project.

Case Group: consecutive outpatients (ages 18-60) diagnosed with Borderline Personality Disorder and Substance Use Disorder according to DSM-5 criteria.
Intervention code [1] 329853 0
Not applicable
Comparator / control treatment
Control Group: outpatients known to the clinic, diagnosed with BPD (according to DSM-5 criteria) without substance use disorder.
Control group
Active

Outcomes
Primary outcome [1] 339758 0
To identify and quantify differences in clinical and demographic variables between patients with borderline personality disorder (BPD) comorbid with substance use disorder (SUD) and a control group of patients with BPD without substance use, as measured by standardized psychometric scales and demographic data collection. All variables will be assessed together as a composite primary outcome.
Timepoint [1] 339758 0
The assessment will be cross-sectional: The recruited patients and control subjects will be evaluated at T0, corresponding to the time of administration of the psychometric tests.
Secondary outcome [1] 441151 0
The secondary outcome of this study is to assess the total score of the Addictive Behavior Questionnaire (ABQ) in patients with borderline personality disorder (BPD) and substance use disorder (SUD). A linear regression analysis will be conducted with the total score of the ABQ as the dependent variable.
Timepoint [1] 441151 0
The assessment will be cross-sectional: The recruited patients and control subjects will be evaluated at T0, corresponding to the time of administration of the psychometric tests.

Eligibility
Key inclusion criteria
Case: Consecutive outpatients (ages 18-60) diagnosed with BPD and SUD according to DSM-5 criteria will be recruited. The diagnosis will be made through evaluation by experienced clinicians and administration of the SCID-5 (Structured Clinical Interview for DSM-5 Personality Disorders).

Controls:
Consecutive outpatients (ages 18-60) diagnosed with BPD according to DSM-5 criteria will be recruited. Diagnosis will be conducted through evaluation by experienced clinicians and administration of the SCID-5 (Structured Clinical Interview for DSM-5 Personality Disorders).
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cases:
a) Presence of neuropsychiatric comorbidities, including: neurodevelopmental disorders; neurocognitive disorders; schizophrenia and schizophrenia spectrum disorders; bipolar disorder;
b) Concurrent major depressive episode;
c) Symptomatic severity assessed by the clinician as incompatible with the administration of psychometric tests.

Controls:
a) Presence of neuropsychiatric comorbidities, assessed according to DSM-5 criteria and including: neurodevelopmental disorders; neurocognitive disorders; schizophrenia and schizophrenia spectrum disorders; bipolar disorder;
b) Concurrent major depressive episode;
c) Current or past use of alcohol and substances;
d) Symptomatic severity incompatible with the administration of psychometric assessments.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Case control
Timing
Retrospective
Statistical methods / analysis
The statistical analysis will consist of an Analysis of Variance (ANOVA) to compare the clinical and demographic variables of the two groups. In the group of patients with BPD and SUD, a linear regression will be conducted using the total ABQ score as the dependent variable.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2024
Date of last participant enrolment
Anticipated
Actual
31/10/2024
Date of last data collection
Anticipated
Actual
31/10/2024
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 26660 0
Italy
State/province [1] 26660 0
Turin

Funding & Sponsors
Funding source category [1] 317725 0
University
Name [1] 317725 0
University of Turin (UniTo)
Country [1] 317725 0
Italy
Primary sponsor type
University
Name
University of Turin (UniTo)
Address
Country
Italy
Secondary sponsor category [1] 320042 0
None
Name [1] 320042 0
Address [1] 320042 0
Country [1] 320042 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316415 0
University of Turin research ethics committee
Ethics committee address [1] 316415 0
Ethics committee country [1] 316415 0
Italy
Date submitted for ethics approval [1] 316415 0
05/10/2022
Approval date [1] 316415 0
27/12/2022
Ethics approval number [1] 316415 0
778.703

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

Contacts
Principal investigator
Name 137818 0
Prof Paola Bozzatello
Address 137818 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 137818 0
Italy
Phone 137818 0
+390116703778
Fax 137818 0
Email 137818 0
[email protected]
Contact person for public queries
Name 137819 0
Paola Bozzatello
Address 137819 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 137819 0
Italy
Phone 137819 0
+390116703778
Fax 137819 0
Email 137819 0
[email protected]
Contact person for scientific queries
Name 137820 0
Paola Bozzatello
Address 137820 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 137820 0
Italy
Phone 137820 0
+390116703778
Fax 137820 0
Email 137820 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.