NCT04086654

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

1.6 years

First QC Date

September 9, 2019

Last Update Submit

November 21, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

International Trauma Interview (ITI)

OTHER
Diagnostic Test: International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German version

Interventions

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.

International Trauma Interview (ITI)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Structured diagnostic procedures upon hospital entry not yet started, except for orienting assessments
  • Able to give informed consent as documented by signature

You may not qualify if:

  • Clinical signs for impaired cognitive abilities
  • Other contraindications to undergo the clinical interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrierte Psychiatrie Winterthur, Spezialstation für Traumafolgestörungen

Winterthur, Canton of Zurich, 8400, Switzerland

Location

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 11, 2019

Study Start

March 2, 2020

Primary Completion

October 15, 2021

Study Completion

October 15, 2021

Last Updated

November 22, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations