NCT05365139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

2.2 years

First QC Date

December 6, 2021

Last Update Submit

August 21, 2025

Conditions

Prolonged Grief Disorder

Keywords

PGDprolonged grief disorderclinical interviewICD-11 PGDDSM-5 Tr PGD

Outcome Measures

Primary Outcomes (1)

  • Prolonged grief disorder (ICD-11 and DSM-TR)

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

    1 day

Secondary Outcomes (3)

  • Post traumatic stress disorder

    1 day

  • Depression and generalized anxiety disorder

    1 day

  • The Aarhus PGD-Scale

    1 day

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Prolonged Grief Disorder

Interventions

Prostaglandins D

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Maja O'Connor

    Aarhus Universitet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
10 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 6, 2021

First Posted

May 9, 2022

Study Start

August 23, 2021

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)