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Prolonged Grief DisorderNCT05365139

Diagnostic Tools for Identifying Prolonged Grief

An observational study of Prolonged Grief Disorder, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Prolonged Grief Disorder
What is being tested?
Structured clinical diagnostic interview for PGD (PGD-I)
How many people
124 participants
Where
1 siteDenmark
Study dates
23 Aug 2021to 1 Nov 2023
How long will I take part?
10 Days
Phase
Observational
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 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Aarhus University

    Aarhus, 8000

Other trials in Denmark

About this study

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.

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

Read the 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

Being tested
Structured clinical diagnostic interview for PGD (PGD-I)
Keywords
PGD, prolonged grief disorder, clinical interview, ICD-11 PGD, DSM-5 Tr PGD
Medical subject headings
Prolonged Grief Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured clinical diagnostic interview for PGD (PGD-I)Other

    Participants were administered the Structured clinical diagnostic interview for PGD (PGD-I) and screened with clinical interviews for PTSD, anxiety and depression. Whether the Aarhus PGD-scale should be answered before or after the interview was randomized.

    The PGD-I and self-report scale were readministered to 50 participants 7-14 days after the initial administration.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prolonged grief disorder (ICD-11 and DSM-TR)

    The Aarhus PGD-interview (dichotomous scoring 0/1 (1 equals worse outcome))

    Measured: 1 day

Secondary outcomes (3)
  1. Post traumatic stress disorder

    the MINI interview adapted to DSM-5 PTSD criteria (structured clinical interview, dichotomous scoring 0/1 (1 equals worse outcome))

    Measured: 1 day

  2. 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))

    Measured: 1 day

  3. The Aarhus PGD-Scale

    Self report questionnaire based on 26 5-point Likert scale items (higher scores equals worse outcome)

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2022
  2. Study start23 Aug 2021
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
124 participants (actual)
Target duration
10 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT05365139
Sponsor's protocol ID
35880 Aarhus University
Status last verified
Aug 2025
First submitted
6 Dec 2021
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prolonged Grief Disorder, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. 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 28 Aug 2025. 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 Denmark. 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?

Prolonged grief disorder (ICD-11 and DSM-TR) (time frame: 1 day). 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 28 Aug 2025.

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