Diagnostic Tools for Identifying Prolonged Grief

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.

Development and validation of first clinical diagnostic interview for assessing Prolonged Grief Disorder (PGD) with the ICD 11 and DSM 5 Tr criteria.

Study Overview

• Status: Recruiting
• Conditions: Prolonged Grief Disorder
• Intervention / Treatment: Other: Structured clinical diagnostic interview for PGD (PGD-I)

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 WHO's 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, e.g. 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 (e.g. 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 participant's 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 Type: Observational
• Enrollment (Anticipated): 125

Contacts and Locations

• Study Contact: Name: Maja O'Connor; Phone Number: +4529870779; Email: maja@psy.au.dk
• Study Contact Backup: Name: Christina Buur Steffensen; Phone Number: +4529241045; Email: Buur@psy.au.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Recruiting
    • Aarhus University
    • Contact: Maja O'Connor; Phone Number: 29870779; Email: maja@psy.au.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Bereaved (Danish) persons who lost a loved one minimum 6 month ago.

Description

Inclusion Criteria:

• Bereaved by the loss a loved one to death minimum 6 month ago
• 18 years or above
• The grief is still (more or less) affecting function/everyday life

Exclusion Criteria:

• Bereaved by other losses than a loved person (e.g., pet, divorce)
• 17 years or younger
• Less than 6 month ago since the loss.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolonged grief disorder (ICD-11 and DSM-TR)	The Aarhus PGD-interview (dichotomous scoring 0/1 (1 equals worse outcome))	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post traumatic stress disorder	the MINI interview adapted to DSM-5 PTSD criteria (structured clinical interview, dichotomous scoring 0/1 (1 equals worse outcome))	1 day
Depression and generalized anxiety disorder	The Schedules for Clinical Assessment in Neuropsychiatry (SCAN) (semi-structrured clinical interview, dichotomous scoring 0/1 (1 equals worse outcome))	1 day
The Aarhus PGD-Scale	Self report questionnaire based on 26 5-point Likert scale items (higher scores equals worse outcome)	1 day

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Maja O'Connor, Aarhus Universitet

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: PGD; prolonged grief disorder; clinical interview; ICD-11 PGD; DSM-5 Tr PGD
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 35880 Aarhus University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No