Post Traumatic Stress Disorder (PTSD)NCT04086654
Psychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD
A study testing International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German version in people with Post Traumatic Stress Disorder (PTSD) and Complex Post-Traumatic Stress Disorder (CPTSD), run by University of Zurich at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Post Traumatic Stress Disorder (PTSD), Complex Post-Traumatic Stress Disorder (CPTSD)
- What is being tested?
- International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German version
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Mar 2020to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Integrierte Psychiatrie Winterthur, Spezialstation für Traumafolgestörungen
Winterthur, Canton of Zurich, 8400
About this study
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.
- Being tested
- International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German version
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German versionDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| International Trauma Interview (ITI) | Other | Not described Receives: Diagnostic Test: International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German version |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Trauma Interview (ITI)
Measured: Up to two weeks upon psychiatric ward entry
Life Event Checklist DSM-5
Measured: Up to two weeks upon psychiatric ward entry
Secondary outcomes (5)
Beck Depression Inventory II
Measured: Up to seven days upon psychiatric ward entry
Brief Symptom Checklist
Measured: Up to seven days upon psychiatric ward entry
Impact of Event Scale Revised Version
Measured: Up to seven days upon psychiatric ward entry
PTSD Checklist for DSM-5
Measured: Up to seven days upon psychiatric ward entry
Borderline Symptom List
Measured: Up to seven days upon psychiatric ward entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start2 Mar 2020
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086654
- Sponsor's protocol ID
- ITI Project
- Status last verified
- Nov 2022
- First submitted
- 9 Sep 2019
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD
- ClinicalTrials.gov ID
- NCT04086654
- Acronym / sponsor ID
- ITI Project
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| International Trauma Interview (ITI) | Other | Diagnostic Test: International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German version |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German versionThe 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. | Diagnostic test | International Trauma Interview (ITI) |
Primary outcome
International Trauma Interview (ITI)
Time frame: Up to two weeks upon psychiatric ward entry
Life Event Checklist DSM-5
Time frame: Up to two weeks upon psychiatric ward entry
5 secondary outcomes
Beck Depression Inventory II
Time frame: Up to seven days upon psychiatric ward entry
Brief Symptom Checklist
Time frame: Up to seven days upon psychiatric ward entry
Impact of Event Scale Revised Version
Time frame: Up to seven days upon psychiatric ward entry
PTSD Checklist for DSM-5
Time frame: Up to seven days upon psychiatric ward entry
Borderline Symptom List
Time frame: Up to seven days upon psychiatric ward entry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Chair organizing the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German version in people with Post Traumatic Stress Disorder (PTSD) and Complex Post-Traumatic Stress Disorder (CPTSD), run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Trauma Interview (ITI) (time frame: Up to two weeks upon psychiatric ward entry). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.