Psychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD

The aim of the project is to evaluate the psychometric properties (e.g. validity, reliability) of the International Trauma Interview (ITI) - German version. The ITI is a structured clinical interview that corresponds to the ICD-11 criteria for diagnosing both posttraumatic stress disorder (PTSD) and complex posttraumatic stress disorder (CPTSD).

Eligible participants from psychiatric inpatient and outpatient facilities in Switzerland who have provided informed will complete various self-report measures about trauma-related mental health complaints. In addition, the ITI will be conducted by a trained clinician. Lastly, information from the medical chart will be further used for scientific purpose. The overall assessment will take approximately 1-2 hours to complete.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder (PTSD); Complex Post-Traumatic Stress Disorder (CPTSD)
• Intervention / Treatment: Diagnostic test: International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German version

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Winterthur, Zurich, Switzerland, 8400
      • Integrierte Psychiatrie Winterthur, Spezialstation für Traumafolgestörungen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Study-specific Inclusion criteria

• Structured diagnostic procedures upon hospital entry not yet started, except for orienting assessments
• Able to give informed consent as documented by signature
• Able to understand and communicate in German Exclusion criteria
• Clinical signs for impaired cognitive abilities
• Other contraindications to undergo the clinical interview

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: International Trauma Interview (ITI)

Diagnostic test: International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German version; The ITI consists of 18 items and for each symptom, standardized questions as well as probes are presented. A trained professional rates both symptom frequency and intensity, which are converted into an overall index of symptom severity. A diagnosis of PTSD/CPTSD is established by applying the ICD-11 diagnostic rules. It takes approximately 30-60 minutes to administer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
International Trauma Interview (ITI)	Up to two weeks upon psychiatric ward entry
Life Event Checklist DSM-5	Up to two weeks upon psychiatric ward entry

Secondary Outcome Measures

Outcome Measure	Time Frame
Beck Depression Inventory II	Up to seven days upon psychiatric ward entry
Brief Symptom Checklist	Up to seven days upon psychiatric ward entry
Impact of Event Scale Revised Version	Up to seven days upon psychiatric ward entry
PTSD Checklist for DSM-5	Up to seven days upon psychiatric ward entry
Borderline Symptom List	Up to seven days upon psychiatric ward entry

Collaborators and Investigators

• Sponsor: University of Zurich

Publications and helpful links

Helpful Links

• Information about ICD-11 PTSD/CPTSD measures
• Chair organizing the study

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: ITI Project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No