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

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ClinicalTrials.gov Identifier: NCT04086654
Recruitment Status : Not yet recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.


Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder (PTSD) Complex Post-Traumatic Stress Disorder (CPTSD) Diagnostic Test: International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German version Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Psychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. International Trauma Interview (ITI) [ Time Frame: Up to two weeks upon psychiatric ward entry ]
  2. Life Event Checklist DSM-5 [ Time Frame: Up to two weeks upon psychiatric ward entry ]

Secondary Outcome Measures :
  1. Beck Depression Inventory II [ Time Frame: Up to seven days upon psychiatric ward entry ]
  2. Brief Symptom Checklist [ Time Frame: Up to seven days upon psychiatric ward entry ]
  3. Impact of Event Scale Revised Version [ Time Frame: Up to seven days upon psychiatric ward entry ]
  4. PTSD Checklist for DSM-5 [ Time Frame: Up to seven days upon psychiatric ward entry ]
  5. Borderline Symptom List [ Time Frame: Up to seven days upon psychiatric ward entry ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inpatient treatment at psychiatric ward due to trauma-related mental health problems
  • Diagnostic procedures upon hospital entry not yet started
  • Able to give informed consent as documented by signature
  • Ability to communicate in German

Exclusion Criteria:

  • clinical signs for acute psychosis or substance abuse disorders (except smoking)
  • acute suicidal tendencies
  • clinical signs for impaired cognitive abilities
  • Inability or contraindications to undergo the clinical interview

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086654


Contacts
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Contact: Andreas Maercker, PhD +41 44 635 73 10 a.maercker@psychologie.uzh.ch

Sponsors and Collaborators
University of Zurich

Additional Information:
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04086654     History of Changes
Other Study ID Numbers: ITI Project
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders