Personality DisorderEIC-PPNCT06623838
An Evolutionarily Informed Conceptualization of Personality Pathology
An observational study of Personality Disorder, run by Tages Onlus at 1 site in Italy.
Trial summary
The purpose of this study is to explore the reliability of a new evolutionarily-informed model for conceptualizing personality pathology. In a preliminary phase prior to the present study we investigated reliability by comparing how therapist pairs conceptualized and assessed the same patient and how therapists and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Personality Disorder
- What is being tested?
- Evolutionarily informed case conceptualization
- How many people
- 110 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Undergraduate students in psychology
Who may be able to join
- Undergraduate students in their final year
- Recently graduated students.
Who cannot join
- having left the university program during the study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Tages Onlus
Florence, 50137
Veronica Cavalletti, +39055679037, veroica.cavalletti@tagesonlus.org
Alessia Saini, +39055679037, alessia.saini@tagesonlus.org
About this study
Official title: An Evolutionarily Informed Conceptualization of Personality Pathology: A Cross-cultural Acceptability and Reliability Study
The purpose of this study is to explore the reliability of a new evolutionarily-informed model for conceptualizing personality pathology. In a preliminary phase prior to the present study we investigated reliability by comparing how therapist pairs conceptualized and assessed the same patient and how therapists and patients assessed the acceptability of the model.
In this new study we want to confirm that the validity data initially collected are valid across cultures and nations.
Therefore, psychology students (n=110) from 5 countries (China, Italy, Poland, Spain, United States) will participate in a specific training on the model and then apply the model on transcripts of the first two sessions and on assessment reports and two supervisors will evaluate the inter-rater reliability and acceptability in using the model on the same patients.
Read the detailed description
The study aims to investigate the cross-cultural validity of a model of assessment and conceptualization of personality disorders. Given the importance of cultural, social and health conditions in the development and maintenance of these disorders, the model will be tested in 5 different countries. This study follows two previous researches that preliminarily explored the feasibility and reliability of the model in couples of Italian patients and therapists (a detailed description of the previous studies is available in the IPD). Below is a brief description of the project registered here:
- Sample (n=110): China (n=22), Italy (n=22), Poland (n=22), Spain (n=22), United States (n=22).
- Primary goal: Interview to assess perceived utility of conceptualization in the whole samples, and then comparing different cultural backgrounds to assess cross-cultural reliability.
- Secondary goals: Scoring in adherence of students by supervisors (same scoring system as in Research 1) to compare Intra Class Correlation within and between national sub-groups.
- Procedure: All participants will access specific online sessions, one for each country sub-group. The first session will correspond to access to a presentation of the theoretical background of the conceptualization model (1 hour in recorded format that participants can access independently). The second session will correspond to an experiential training in which the model will be presented in detail with various clinical cases and a first exercise on the use of this model will be conducted (2.5 hours in live format with all participants simultaneously). The third session will instead be aimed at applying the model on a case that will be presented to all participants and will correspond to a transcript of the two initial sessions and a report on the results of the questionnaires (0.5 hour in live format that participants can access independently). The fourth session will be accessed by some participants (n= 5 per country) and will correspond to a structured interview conducted by a researcher on the acceptability and usefulness of the model (live format that participants can access independently).
- Conditions
- Personality Disorder
- Being tested
- Evolutionarily informed case conceptualization
- Keywords
- evolutionary systems therapy, personality disoders, personality pathology, evolutionary psychopathology, psychotherapy, case conceptualization
- Medical subject headings
- Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolutionarily informed case conceptualizationDiagnostic test
Case conceptualization of personality functioning of a few transcripts of initial sessions and report of psychometric measures of patients diagnosed with personality disorder.
| Study group | Role | What they receive |
|---|---|---|
| Spanish group | Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization. Receives: Diagnostic Test: Evolutionarily informed case conceptualization | |
| Polish group | Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization. Receives: Diagnostic Test: Evolutionarily informed case conceptualization | |
| Chinese group | Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization. Receives: Diagnostic Test: Evolutionarily informed case conceptualization | |
| Italian group | Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization. Receives: Diagnostic Test: Evolutionarily informed case conceptualization | |
| American group | Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization. Receives: Diagnostic Test: Evolutionarily informed case conceptualization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-cultural inter-rater reliabilitt
Inter-rater reliability of adherence to the case conceptualization within any single group will be compared with the Italian group where the diagnostic procedure was initially validated to confirm that there are no differences in reliability between Italian group and the other groups. Inter-rater reliability will be scored as kappa values and intraclass correlation coefficients.
Measured: From the enrollment to the end of the end of the diagnostic procedure that last 1 hours and will be performed within 1 month from the recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start6 May 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tages Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623838
- Sponsor's protocol ID
- EIC-PP
- Acronym
- EIC-PP
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Description of research, statistical plan and dataset will be published on OSF. Description of research and statistical plan are available, whereas dataset at the end of the data collection (between January and March, 2025). To access OSF files: https://osf.io/hnyz6/
Publications
Cheli S, Cavalletti V, Lysaker PH, Dimaggio G, Petrocchi N, Chiarello F, Enzo C, Velicogna F, Mancini F, Goldzweig G. A pilot randomized controlled trial comparing a novel compassion and metacognition approach for schizotypal personality disorder with a combination of cognitive therapy and psychopharmacological treatment. BMC Psychiatry. 2023 Feb 20;23(1):113. doi: 10.1186/s12888-023-04610-5.
PubMed 36803673Cheli S, Goldzweig G, Chiarello F, Cavalletti V. Evolutionary systems therapy for paranoid personality disorder: A seven cases series. Bull Menninger Clin. 2024 Winter;88(1):61-80. doi: 10.1521/bumc.2024.88.1.61.
PubMed 38527104
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evolutionarily Informed Conceptualization of Personality Pathology: A Cross-cultural Acceptability and Reliability Study
- ClinicalTrials.gov ID
- NCT06623838
- Acronym / sponsor ID
- EIC-PP / EIC-PP
- Conditions
- Personality Disorder
- Keywords
- evolutionary systems therapy, personality disoders, personality pathology, evolutionary psychopathology, psychotherapy, case conceptualization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Tages OnlusUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the reliability of a new evolutionarily-informed model for conceptualizing personality pathology. In a preliminary phase prior to the present study we investigated reliability by comparing how therapist pairs conceptualized and assessed the same patient and how therapists and patients assessed the acceptability of the model.
In this new study we want to confirm that the validity data initially collected are valid across cultures and nations.
Therefore, psychology students (n=110) from 5 countries (China, Italy, Poland, Spain, United States) will participate in a specific training on the model and then apply the model on transcripts of the first two sessions and on assessment reports and two supervisors will evaluate the inter-rater reliability and acceptability in using the model on the same patients.
Detailed description
The study aims to investigate the cross-cultural validity of a model of assessment and conceptualization of personality disorders. Given the importance of cultural, social and health conditions in the development and maintenance of these disorders, the model will be tested in 5 different countries. This study follows two previous researches that preliminarily explored the feasibility and reliability of the model in couples of Italian patients and therapists (a detailed description of the previous studies is available in the IPD). Below is a brief description of the project registered here:
- Sample (n=110): China (n=22), Italy (n=22), Poland (n=22), Spain (n=22), United States (n=22).
- Primary goal: Interview to assess perceived utility of conceptualization in the whole samples, and then comparing different cultural backgrounds to assess cross-cultural reliability.
- Secondary goals: Scoring in adherence of students by supervisors (same scoring system as in Research 1) to compare Intra Class Correlation within and between national sub-groups.
- Procedure: All participants will access specific online sessions, one for each country sub-group. The first session will correspond to access to a presentation of the theoretical background of the conceptualization model (1 hour in recorded format that participants can access independently). The second session will correspond to an experiential training in which the model will be presented in detail with various clinical cases and a first exercise on the use of this model will be conducted (2.5 hours in live format with all participants simultaneously). The third session will instead be aimed at applying the model on a case that will be presented to all participants and will correspond to a transcript of the two initial sessions and a report on the results of the questionnaires (0.5 hour in live format that participants can access independently). The fourth session will be accessed by some participants (n= 5 per country) and will correspond to a structured interview conducted by a researcher on the acceptability and usefulness of the model (live format that participants can access independently).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Spanish group | – | Diagnostic Test: Evolutionarily informed case conceptualizationGroup/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization. |
| Polish group | – | Diagnostic Test: Evolutionarily informed case conceptualizationGroup/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization. |
| Chinese group | – | Diagnostic Test: Evolutionarily informed case conceptualizationGroup/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization. |
| Italian group | – | Diagnostic Test: Evolutionarily informed case conceptualizationGroup/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization. |
| American group | – | Diagnostic Test: Evolutionarily informed case conceptualizationGroup/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Undergraduate students in psychology
Key inclusion criteria (2 listed)
- Undergraduate students in their final year
- Recently graduated students.
Key exclusion criteria (1 listed)
- having left the university program during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evolutionarily informed case conceptualizationCase conceptualization of personality functioning of a few transcripts of initial sessions and report of psychometric measures of patients diagnosed with personality disorder. | Diagnostic test | American group, Chinese group, Italian group, Polish group, Spanish group |
Primary outcome
Cross-cultural inter-rater reliabilitt
Time frame: From the enrollment to the end of the end of the diagnostic procedure that last 1 hours and will be performed within 1 month from the recruitment.
Inter-rater reliability of adherence to the case conceptualization within any single group will be compared with the Italian group where the diagnostic procedure was initially validated to confirm that there are no differences in reliability between Italian group and the other groups. Inter-rater reliability will be scored as kappa values and intraclass correlation coefficients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Results publication: PubMed 36803673Cheli S, Cavalletti V, Lysaker PH, Dimaggio G, Petrocchi N, Chiarello F, Enzo C, Velicogna F, Mancini F, Goldzweig G. A pilot randomized controlled trial comparing a novel compassion and metacognition approach for schizotypal personality disorder with a combination of cognitive therapy and psychopharmacological treatment. BMC Psychiatry. 2023 Feb 20;23(1):113. doi: 10.1186/s12888-023-04610-5.
- Results publication: PubMed 38527104Cheli S, Goldzweig G, Chiarello F, Cavalletti V. Evolutionary systems therapy for paranoid personality disorder: A seven cases series. Bull Menninger Clin. 2024 Winter;88(1):61-80. doi: 10.1521/bumc.2024.88.1.61.
- Individual participant dataSharing planned: Yes. Description of research, statistical plan and dataset will be published on OSF. Description of research and statistical plan are available, whereas dataset at the end of the data collection (between January and March, 2025). To access OSF files: https://osf.io/hnyz6/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Personality Disorder, run by Tages Onlus at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone Cheli, PhD (+39 055679037, simone.cheli@tagesonlus.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-cultural inter-rater reliabilitt (time frame: From the enrollment to the end of the end of the diagnostic procedure that last 1 hours and will be performed within 1 month from the recruitment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06623838, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.