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.
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.
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
- Develop and validate the first structured, clinical interview for ICD-11 PGD and DSM-5 Tr PGD
- 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
- Conditions
- Prolonged Grief Disorder
- 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.
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)
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
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
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.
- First posted9 May 2022
- Study start23 Aug 2021
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Grief DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 124 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maja O'Connor, University of Aarhus
- Investigators
- Maja O'Connor, Principal investigator, Aarhus Universitet
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05365139
- Acronym / sponsor ID
- 35880 Aarhus University
- Conditions
- Prolonged Grief Disorder
- Keywords
- PGD, prolonged grief disorder, clinical interview, ICD-11 PGD, DSM-5 Tr PGD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 9 May 2022 (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.
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 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
- Develop and validate the first structured, clinical interview for ICD-11 PGD and DSM-5 Tr PGD
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Bereaved (Danish) persons who lost a loved one minimum 6 month ago.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Bereaved by other losses than a loved person (e.g., pet, divorce)
- 17 years or younger
- Less than 6 month ago since the loss.
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 |
|---|---|---|
| Structured clinical diagnostic interview for PGD (PGD-I)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. | Other | – |
Primary outcome
Prolonged grief disorder (ICD-11 and DSM-TR)
Time frame: 1 day
The Aarhus PGD-interview (dichotomous scoring 0/1 (1 equals worse outcome))
3 secondary outcomes
Post traumatic stress disorder
Time frame: 1 day
Depression and generalized anxiety disorder
Time frame: 1 day
The Aarhus PGD-Scale
Time frame: 1 day
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 28 Aug 2025.
- 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.
Maja O'Connor principal investigator
Aarhus Universitet
1 site in 1 country: see every site and its status.
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.