Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000149460
Ethics application status
Approved
Date submitted
1/07/2015
Date registered
8/02/2016
Date last updated
18/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changes in brain activities seen on functional magnetic resonance imaging (fMRI) during autobiographical tasks in patients with borderline personality disorder.
Scientific title
Differences in brain functioning with autobiographical task during fMRI between patients with borderline personality disorder and healthy controls.
Secondary ID [1] 287032 0
None
Universal Trial Number (UTN)
U1111-1171-7620
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline personality disorder 295500 0
Condition category
Condition code
Mental Health 295759 295759 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objective of the present study is to investigate with fMRI the differences in brain functioning between BPD patients and healthy controls during a task of autobiographical memory. In particular, we evaluated brain functioning in patients with identity diffusion, a core psychopathological factor of BPD that had not been assessed in previous investigations. Based on recent findings about neural correlates involved in patients with BPD during autobiographical memories we hypothesised that BPD patients with a deficit in identity integration may present a higher brain activation in dorsolateral prefrontal cortex, insula, anterior cingulate cortex, and temporal parietal junction during the recall of significant life events, both resolved and unresolved, in comparison with controls.
Patients with a diagnosis of BPD and a group of healthy subjects will be enrolled.
Assessment will be performed only on one occasion (baseline).
Autobiographical Interview will be performed to all subjects a week before MRI by an expert clinician (psychiatrist). The duration of interview will be about 90 minutes. Autobiographical Interview will allow to obtain 2 unresolved life events and 2 resolved life events. For each event subjects will provide 4 key-words that will be used to trigger active recall during fMRI. All subjects will undergo a training session immediatly before fMRI. fMRI will be performed by a radiologist.
During assessment, patients and controls will choose 4 neutral events from a pool of brief reports/events (24-26 words).Each report/event has 4 key-words. This pool of reports was previously administered to 100 subjects, who indicated what reports were neutral. Only reports that > 80% of subjects considered neutral will use in the task as resting condition.
Study will be a bloch design characterized by the following conditions:
- activation condition: presentation with eye-glasses a brief summary of life event (24-26 words for each event) for 10 seconds, fixation cross for 10 seconds, key-word event-related for 10 seconds, fixation cross for 10 seconds.
- Resting condition: presentation of neutral report/event(24-26 words) for 10 seconds, fixation cross for 10 seconds, key-word report/event related for 10 seconds, fixation cross for 10 seconds.
This cycle will be repeated for 32 times.
Tasks will be projected from the computer to the specific MRI eye-glassess that patient will wear during fMRI.
Activation condition will immediately follow resting condition. MRI registration will continue for all 32 cycle repeats.
BPD patients and healthy controls will be undergone activation conditions and resting conditions. Each bloch will last 40 seconds.
Functional images will be aquired and compared between patients and controls.
Intervention code [1] 292241 0
Diagnosis / Prognosis
Comparator / control treatment
Brain activity of BPD patients will be compared to healthy controls during fMRI
Control group
Active

Outcomes
Primary outcome [1] 295469 0
Identity Disturbance Questionnaire (IDQ) total score to assess the relation between identity disturbance and alterations of brain functioning, measured during fMRI.
Timepoint [1] 295469 0
Identity Disturbance Questionnaire will be performed one week prior fMRI. During fMRI it will be done a continuous monitoring of brain activity for 30 seconds from time that each key-word is given and brain functioning will be also assessed during resting condition.
Primary outcome [2] 295470 0
Difference of change in brain activity during autobiographical task between patients and controls who have undergone fMRI will be registered. These data will be inserted into the Statistical Parametrical Mapping (SPM), a specific program to elaborate fMRI data.
Timepoint [2] 295470 0
fMRI assessment will be continuously done during active condition (for 30 seconds after the key-word presentation) and during resting condition (30 seconds after the fixation cross presentation).
Secondary outcome [1] 315646 0
Global symptoms assessed with the Clinical Global Impression Scale-Severity (CGI-S)
Timepoint [1] 315646 0
CGI-S will be performed one week before the fMRI
Secondary outcome [2] 315647 0
Specific borderline symptomatology measured with the Borderline Personality Disorder Severity Index (BPDSI)
Timepoint [2] 315647 0
BPDSI will be performed one week before the fMRI
Secondary outcome [3] 315648 0
Affective symptoms measured with the Hamilton Scale for Depression (HAM-D)
Timepoint [3] 315648 0
HAM-D will be performed one week before the fMRI
Secondary outcome [4] 315649 0
Interpersonal functioning measured with the Social and Occupational Functioning Assessing Scale (SOFAS)
Timepoint [4] 315649 0
SOFAS will be performed one week before the fMRI
Secondary outcome [5] 315651 0
Traumatic events assessed with The Childhood Trauma Questionnaire (CTQ)
Timepoint [5] 315651 0
CTQ will be performed one week before the fMRI
Secondary outcome [6] 315894 0
Anxious symtoms measured with the Hamilton Scale for Anxiety (HAM-A)
Timepoint [6] 315894 0
HAM-A will be performed one week before the fMRI

Eligibility
Key inclusion criteria
Patients: diagnosis of borderline personality disorder.
Controls: subjects mached for age and gender without psychiatric disorders and neurological diseases.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia, delirium, and other cognitive disorders; brain injuries; schizophrenia and other psychotic disorders; bipolar disorders; concurrent major depressive episode; substance abuse in the last two months; pharmacological treatments in the last three weeks; pregnant women.

Study design
Purpose of the study
Diagnosis
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
Statistical methods / analysis
Statistical Parametric Mapping (SPM-12) and Analysis of Variance (ANOVA) to evaluate the differences between groups.
40 BPD patients and 40 healthy controls will be enrolled.
No sample size calculations were conducted.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
28/02/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
45
Final
Recruitment outside Australia
Country [1] 7015 0
Italy
State/province [1] 7015 0
Turin

Funding & Sponsors
Funding source category [1] 291583 0
University
Name [1] 291583 0
Centre for Personality Disorders, Psychiatric Clinic, Department of Neuroscience, Univerisity of Turin, Italy
Country [1] 291583 0
Italy
Primary sponsor type
University
Name
Centre for Personality Disorders, Psychiatric Clinic, Department of Neuroscience, Univerisity of Turin, Italy
Address
Centre for Personality Disorders, Psychiatric Clinic, Department of Neuroscience, Univerisity of Turin, Via Cherasco 11, 10126, Turin, Italy
Country
Italy
Secondary sponsor category [1] 290259 0
None
Name [1] 290259 0
Address [1] 290259 0
Country [1] 290259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293116 0
Comitato Etico Interaziendale A.O.U. Citta della Salute e della Scienza di Torino, A.O. Ordine Mauriziano ASL TO1.
Ethics committee address [1] 293116 0
Ethics committee country [1] 293116 0
Italy
Date submitted for ethics approval [1] 293116 0
30/06/2015
Approval date [1] 293116 0
30/09/2015
Ethics approval number [1] 293116 0
0094867

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

Contacts
Principal investigator
Name 58554 0
Prof Silvio Bellino
Address 58554 0
Department of Neuroscience, Psychiatric Clinic, University of Turin, Via Cherasco 11, 10126, Turin, Italy.
Country 58554 0
Italy
Phone 58554 0
+39 011-6634848
Fax 58554 0
+39 011-673473
Email 58554 0
[email protected]
Contact person for public queries
Name 58555 0
Paola Bozzatello
Address 58555 0
Department of Neuroscience, Psychiatric Clinic, University of Turin, Via Cherasco 11, 10126, Turin, Italy.
Country 58555 0
Italy
Phone 58555 0
+39 011-6634848
Fax 58555 0
+39 011-673473
Email 58555 0
[email protected]
Contact person for scientific queries
Name 58556 0
Chiara Brunetti
Address 58556 0
Department of Neuroscience, Psychiatric Clinic, University of Turin, Via Cherasco 11, 10126, Turin, Italy.
Country 58556 0
Italy
Phone 58556 0
+39 011-6634848
Fax 58556 0
+39 011-673473
Email 58556 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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