NCT06623838

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 17, 2024

Last Update Submit

September 30, 2024

Conditions

Keywords

evolutionary systems therapypersonality disoderspersonality pathologyevolutionary psychopathologypsychotherapycase conceptualization

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

Study Arms (5)

Spanish group

Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization.

Diagnostic Test: Evolutionarily informed case conceptualization

Polish group

Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization.

Diagnostic Test: Evolutionarily informed case conceptualization

Chinese group

Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization.

Diagnostic Test: Evolutionarily informed case conceptualization

Italian group

Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization.

Diagnostic Test: Evolutionarily informed case conceptualization

American group

Group/Cohort Description: 22 students in MA in clinical psychology performing the evolutionarily informed case conceptualization.

Diagnostic Test: Evolutionarily informed case conceptualization

Interventions

Case conceptualization of personality functioning of a few transcripts of initial sessions and report of psychometric measures of patients diagnosed with personality disorder.

American groupChinese groupItalian groupPolish groupSpanish group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Undergraduate students in psychology

You may qualify if:

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

You may not qualify if:

  • having left the university program during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tages Onlus

Florence, 50137, Italy

RECRUITING

Related Publications (2)

  • 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.

  • Cheli 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.

MeSH Terms

Conditions

Personality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2024

First Posted

October 2, 2024

Study Start

May 6, 2024

Primary Completion

February 28, 2025

Study Completion

April 1, 2025

Last Updated

October 2, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

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/

Shared Documents
STUDY PROTOCOL, SAP
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).
Access Criteria
Open access
More information

Available IPD Datasets

Study Protocol (HNYZ6)Access

Locations