Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000144516
Ethics application status
Approved
Date submitted
31/08/2023
Date registered
15/02/2024
Date last updated
15/02/2024
Date data sharing statement initially provided
15/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Social Cognition Individualized Activities Lab (SoCIAL) - cognitive training in Borderline Personality Disorder: a pilot study
Scientific title
The effect of SoCIAL cognitive training on social cognitive skills in Borderline Personality Disorder: a pilot study comparing BPD patients attending SoCIAL training program with BPD patients in waiting list.
Secondary ID [1] 310523 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
borderline personality disorder 331341 0
Condition category
Condition code
Mental Health 328091 328091 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions:
10 rehabilitation sessions using the SoCIAL program. Session are delivered weekly (10 weeks program), individually, face-to-face
Structure of each session:
First module (30 minutes)
The first module uses multimedia material as an aid in the recognition training of basic emotions and secondary, social emotions. In practical terms, the therapist shows the patient some photographs of actors reproducing the typical mimicry of a basic emotion (fear, sadness, happiness, angry, disgust and neutral) at different intensities. The patient is then asked to recognize the proposed emotion. During this activity it is possible to guide the patient in identifying peculiar interpretative tendencies, such as a possible susceptibility to negative emotions or a tendency to perceive the other as angry or hostile.
The operation is repeated on film clips showing some simple social interactions with an attached emotional component. Finally, video material showing more complex interaction and addressing Theory of Mind skills is presented.
Multimedia material is provided by Department of Psychiatry, University of Campania "Luigi Vanvitelli," Naples, Italy.

Second module (30 minutes)
The second part of the session includes the narrative enhancement module, specifically developed for the metacognitive skills of recognizing and integrating mental states, such as emotions desires, attitudes and goals, in real-life situations. The patient and therapist analyze together relational or social situations experienced in everyday life, with the aim of apply the skills discussed in the first module.

It is a semi-structured intervention, with the possibility to personalize any session according to subjectives deficits, skills or necessities.

The intervention is administered by two psychiatry residents with at least three years of experience (one therapist conducing the talk and one reporting annotations for later discussion). A supervision carried out by an expert psychiatrist in taking place once per month. Each therapist involved in SoCIAL intervention followed a two-days class held from the Department of Psychiatry, University of Campania "Luigi Vanvitelli," Naples, Italy.

Setting: outpatient clinics in the SC Psichiatria Universitaria of "AOU Cittá della Salute e della Scienza" Hospital, Turin, Italy.

Patients are not allowed to skip or delay more than two sessions. In this case they will be considered as drop-outs.
Intervention code [1] 326919 0
Treatment: Other
Comparator / control treatment
Control group: patients with a diagnosis of Borderline Personality Disorder (BPD) according to DSM-5 criteria, who receive treatment as usual (periodical check-ups, pharmacotherapy and/or psychotherapy). Controls and are in waiting list (WL)
for SoCIAL training: they will receive access to the SoCIAL training at the conclusion of the study (at least 12 weeks post-enrolment).
Control group
Active

Outcomes
Primary outcome [1] 335960 0
Primary outcome: any change in social cognition skills, assessed using Reading the Mind in the Eyes Test (RMEIT) and Facial Emotion Identification Test (FEIT).
Timepoint [1] 335960 0
Recruited patients and control subjects will be evaluated at baseline (t0) and at 10 weeks post enrolment
(t1).
Primary outcome [2] 337382 0
Primary outcome: any change in narrative coherence, assessed with Narrative Coherence Coding Scheme (NaCCS).
Timepoint [2] 337382 0
Recruited patients and control subjects will be evalueted at baseline (t0) and at 10 weeks post enrolment (t1)
Secondary outcome [1] 426251 0
Secondary outcomes: Any change at psychometric scales assessing severity of symptoms assessed using Borderline Personality Disorder Severity Index-IV (BPDSI-IV) and Clinical Global Impression Severity (CGI-S);
Timepoint [1] 426251 0
Recruited patients and control subjects will be evaluated at baseline (t0) and at 10 weeks post enrolment
(t1).
Secondary outcome [2] 431623 0
Secondary outcomes: Any change at psychometric scales assessing social and global functioning assessed using Occupational Functioning Assessment Scale (SOFAS);
Timepoint [2] 431623 0
Recruited patients and control subjects will be evaluated at baseline (t0) and at 10 weeks post enrolment (t1).
Secondary outcome [3] 431624 0
Secondary outcomes: Any change at psychometric scales assessing cognitive abilities assessed using Screen for cognitive impairment in psychiatry (SCIP).
Timepoint [3] 431624 0
Recruited patients and control subjects will be evaluated at baseline (t0) and at 10 weeks post enrolment (t1).

Eligibility
Key inclusion criteria
Consecutive (18-60 years), outpatients with a diagnosis of 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).
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 the intervention 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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis will be conducted by ANOVA test for each variable (scoring difference between T0 and T1). A p value < 0,05% will be considered.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/09/2023
Date of last participant enrolment
Anticipated
31/08/2026
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
60
Accrual to date
20
Final
Recruitment outside Australia
Country [1] 25750 0
Italy
State/province [1] 25750 0

Funding & Sponsors
Funding source category [1] 314727 0
University
Name [1] 314727 0
University of Turin
Country [1] 314727 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 (10126)
Country
Italy
Secondary sponsor category [1] 316699 0
None
Name [1] 316699 0
Address [1] 316699 0
Country [1] 316699 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313737 0
CET Interaziendale AOU Città della Salute e della Scienza di Torino
Ethics committee address [1] 313737 0
Ethics committee country [1] 313737 0
Italy
Date submitted for ethics approval [1] 313737 0
31/08/2023
Approval date [1] 313737 0
30/10/2023
Ethics approval number [1] 313737 0
819.513

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

Contacts
Principal investigator
Name 129190 0
Prof Silvio Bellino
Address 129190 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 (10126)
Country 129190 0
Italy
Phone 129190 0
+390116703778
Fax 129190 0
Email 129190 0
[email protected]
Contact person for public queries
Name 129191 0
Silvio Bellino
Address 129191 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 (10126)
Country 129191 0
Italy
Phone 129191 0
+390116703778
Fax 129191 0
Email 129191 0
[email protected]
Contact person for scientific queries
Name 129192 0
Silvio Bellino
Address 129192 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 (10126)
Country 129192 0
Italy
Phone 129192 0
+390116703778
Fax 129192 0
Email 129192 0
[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


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.