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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04086654
Other study ID # ITI Project
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2, 2020
Est. completion date October 15, 2021

Study information

Verified date November 2022
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date October 15, 2021
Est. primary completion date October 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Switzerland Integrierte Psychiatrie Winterthur, Spezialstation für Traumafolgestörungen Winterthur Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary International Trauma Interview (ITI) Up to two weeks upon psychiatric ward entry
Primary Life Event Checklist DSM-5 Up to two weeks upon psychiatric ward entry
Secondary Beck Depression Inventory II Up to seven days upon psychiatric ward entry
Secondary Brief Symptom Checklist Up to seven days upon psychiatric ward entry
Secondary Impact of Event Scale Revised Version Up to seven days upon psychiatric ward entry
Secondary PTSD Checklist for DSM-5 Up to seven days upon psychiatric ward entry
Secondary Borderline Symptom List Up to seven days upon psychiatric ward entry
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