Viewing Study NCT05365139



Ignite Creation Date: 2024-05-06 @ 5:35 PM
Last Modification Date: 2024-10-26 @ 2:32 PM
Study NCT ID: NCT05365139
Status: UNKNOWN
Last Update Posted: 2022-05-09
First Post: 2021-12-06

Brief Title: Diagnostic Tools for Identifying Prolonged Grief
Sponsor: University of Aarhus
Organization: University of Aarhus

Study Overview

Official Title: Diagnostic Tools for Identifying Prolonged Grief Development and Validation of the First Clinical Diagnostic Interview for Assessing Prolonged Grief Disorder With the ICD 11 Criteria and DSM-5 Tr Criteria
Status: UNKNOWN
Status Verified Date: 2022-05
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Development and validation of first clinical diagnostic interview for assessing Prolonged Grief Disorder PGD with the ICD 11 and DSM 5 Tr criteria
Detailed Description: Development and validation of first clinical diagnostic interview for assessing Prolonged Grief Disorder PGD with the ICD 11 and DSM 5 Tr criteria

Background With WHOs introduction of PGD in the ICD 11 which will be implemented in Health Services worldwide from January 2022 there is a need to accurately diagnose people with ICD-11PGD PGD caseness with a valid structured clinical interview

With ICD-11 a slightly different set of symptoms for PGD is defined as the gold standard for PGD This standard will be used for diagnosing and understanding PGD in future research and health service ICD-11 aims to be descriptive eg provides a support for the clinicians to identify PGD by describing common reactions and symptoms of this disorder but there is still a need to evaluate the validity of these criteria Strict diagnostic criteria with defined numbers combinations and intensity of symptoms eg for the use in research are not yet defined in ICD-11 and no structured clinical interview that measure ICD-11 or the upcoming DSM 5 tr PGD has yet been developed and validated for this purpose This means that the field currently stand without reliable ways to classify accurately who has PGD diagnosis and who has not Without such constructs PGD is not possible to identify and ultimately to treat in a validated and reliable way

There is therefore a need to develop accurate tests that measure ICD 11 PGD both in a structured clinical interview for use in direct meetings between patients and health service professionals and in relation to a self-report scale The investigators already developed the Aarhus PGD scale but still need a structured clinical interview

Aim In this project we will

1 Develop and validate the first structured clinical interview for ICD-11 PGD and DSM-5 Tr PGD
2 Identify a valid clinical cut-off for diagnostic PGD on The Aarhus PGD Scale

Method

Based on the ICD-11 and DSM 5 Tr PGD criteria and our work with the self-report scale above the investigators will develop a structured clinical interview The Aarhus PGD Interview in line with the strategy used in SCID-I interviews 6 This study will examine the content validity the concurrent validity the test-retest reliability and the inter-rater reliability of this interview

After the Aarhus PGD Interview is validated this study will compare the participants scores on the Aarhus PGD Scale for ICD 11 and DSM 5 Tr PGD with the clinical interview as the gold standard This will allow investigating the diagnostic test accuracy of the ICD-11 PGD scale and to identify a valid clinical cut-off on this scale

Perspectives The main aim of this study is to develop and validate the first structured clinical interview for ICD 11 and DSM 5 Tr PGD It will provide reliable constructs to separate PGD from other trans-diagnostic forms of complicated grief reactions such as PTSD depression and anxiety following a loss The ability to identify who actually has a diagnosis of PGD and are in need of treatment is crucial to be able to allocate health benefits as efficient and helpful as possible It is also crucial in identifying the vast majority of bereaved people with normal grief reactions and to reduce the risk of pathologizing healthy grief which is a concern brought on by the introduction of PGD as a diagnostic entity

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None