Back to resultsPsychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD
Primary Purpose
Post Traumatic Stress Disorder (PTSD), Complex Post-Traumatic Stress Disorder (CPTSD)
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German version
Sponsored by
About this trial
This is an interventional diagnostic trial for Post Traumatic Stress Disorder (PTSD)
Eligibility Criteria
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
Sites / Locations
- Integrierte Psychiatrie Winterthur, Spezialstation für Traumafolgestörungen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
International Trauma Interview (ITI)
Arm Description
Outcomes
Primary Outcome Measures
International Trauma Interview (ITI)
Life Event Checklist DSM-5
Secondary Outcome Measures
Beck Depression Inventory II
Brief Symptom Checklist
Impact of Event Scale Revised Version
PTSD Checklist for DSM-5
Borderline Symptom List
Full Information
NCT ID
NCT04086654
First Posted
September 9, 2019
Last Updated
November 21, 2022
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT04086654
Brief Title
Psychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD
Official Title
Psychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder (PTSD), Complex Post-Traumatic Stress Disorder (CPTSD)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
International Trauma Interview (ITI)
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German version
Intervention Description
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.
Primary Outcome Measure Information:
Title
International Trauma Interview (ITI)
Time Frame
Up to two weeks upon psychiatric ward entry
Title
Life Event Checklist DSM-5
Time Frame
Up to two weeks upon psychiatric ward entry
Secondary Outcome Measure Information:
Title
Beck Depression Inventory II
Time Frame
Up to seven days upon psychiatric ward entry
Title
Brief Symptom Checklist
Time Frame
Up to seven days upon psychiatric ward entry
Title
Impact of Event Scale Revised Version
Time Frame
Up to seven days upon psychiatric ward entry
Title
PTSD Checklist for DSM-5
Time Frame
Up to seven days upon psychiatric ward entry
Title
Borderline Symptom List
Time Frame
Up to seven days upon psychiatric ward entry
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Integrierte Psychiatrie Winterthur, Spezialstation für Traumafolgestörungen
City
Winterthur
State/Province
Zurich
ZIP/Postal Code
8400
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.traumameasuresglobal.com/itq
Description
Information about ICD-11 PTSD/CPTSD measures
URL
https://www.psychology.uzh.ch/en/areas/hea/psypath.html
Description
Chair organizing the study
Learn more about this trial
Psychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD
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