An Evolutionarily Informed Conceptualization of Personality Pathology (EIC-PP)

September 30, 2024 updated by: Tages Onlus

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Undergraduate students in psychology

Description

Inclusion Criteria:

  • Undergraduate students in their final year
  • Recently graduated students.

Exclusion Criteria:

  • having left the university program during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spanish group
Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization.
Diagnostic test: Evolutionarily informed case conceptualization
Case conceptualization of personality functioning of a few transcripts of initial sessions and report of psychometric measures of patients diagnosed with personality disorder.
Polish group
Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization.
Diagnostic test: Evolutionarily informed case conceptualization
Case conceptualization of personality functioning of a few transcripts of initial sessions and report of psychometric measures of patients diagnosed with personality disorder.
Chinese group
Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization.
Diagnostic test: Evolutionarily informed case conceptualization
Case conceptualization of personality functioning of a few transcripts of initial sessions and report of psychometric measures of patients diagnosed with personality disorder.
Italian group
Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization.
Diagnostic test: Evolutionarily informed case conceptualization
Case conceptualization of personality functioning of a few transcripts of initial sessions and report of psychometric measures of patients diagnosed with personality disorder.
American group
Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization.
Diagnostic test: Evolutionarily informed case conceptualization
Case conceptualization of personality functioning of a few transcripts of initial sessions and report of psychometric measures of patients diagnosed with personality disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tages Onlus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIC-PP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/

IPD Sharing Time Frame

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).

IPD Sharing Access Criteria

Open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Study Data/Documents

  1. Study Protocol
    Information identifier: HNYZ6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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