NCT03049007

Brief Summary

Psychological distress is a natural reaction following the death of a loved one. Nevertheless, research has shown that for a significant minority of bereaved individuals the grieving process is disturbed. These individuals experience an intense grief reaction that persists across time characterized by longing for the deceased or persistent preoccupation with the deceased. It has been suggested that this intense, persistent grief reaction meets criteria to be considered a distinct mental disorder. Prolonged grief disorder (PGD) has been proposed to capture this condition and will be included in the forthcoming ICD-11. The proposed project aims to prepare healthcare services to use the diagnosis of prolonged grief disorder (PGD) by determining the frequency of PDG in a population sample of bereaved spouses and their adult children. It will also identify early predictors of PGD and trajectories of natural and prolonged grief as well as investigate the specificity of PGD in relation to other common loss-related reactions. Thus, the project will provide a prognostic tool to identify individuals with high versus low risk of developing PGD.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,243

participants targeted

Target at P75+ for all trials

Timeline
47mo left

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress70%
Feb 2017Apr 2030

First Submitted

Initial submission to the registry

February 7, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Expected
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

7.2 years

First QC Date

February 7, 2017

Last Update Submit

August 21, 2025

Conditions

Keywords

bereavementnatural griefprolonged griefcomplicated grief

Outcome Measures

Primary Outcomes (2)

  • Prolonged grief

    Changes in prolonged grief symptoms measured using the Prolonged Grief Disorder-13 (PG-13; Prigerson et al., 2009)

    2, 6, 11, 18, and 26 months post-loss

  • Complicated grief

    Changes in complicated grief symptoms measured using the Inventory of Complicated Grief Revised (ICG-R; Prigerson \& Jacobs, 2001)

    2, 6, 11, 18, and 26 months post-loss

Secondary Outcomes (5)

  • Depression

    2, 6, 11, 18, and 26 months post-loss

  • Generalized anxiety

    2, 6, 11, 18, and 26 months post-loss

  • Post-traumatic stress

    2, 6, 11, 18, and 26 months post-loss

  • Well-being

    2, 6, 11, 18, and 26 months post-loss

  • Mental and physical health

    2, 18, and 26 months post-loss

Other Outcomes (9)

  • Loneliness

    2, 6, 11, 18, and 26 months post-loss

  • Rumination

    2, 6, and 11 months post-loss

  • Social support

    2, 6, and 11 months post-loss

  • +6 more other outcomes

Study Arms (2)

Partner

Spousal bereaved individuals (age 25-85) in the Central Denmark Region identified through a data extraction of the Danish Civil Registration System (CPR) every sixth week over a period of one year. The group will complete a survey at respectively 2 (T1), 6 (T2), 11 (T3), 18 (T4), and 26 (T5) months post-loss as well as 3, 4, 5 and 6 years post loss.

Diagnostic Test: Survey

Child

Parental bereaved individuals (age 18 or above) that are children of the partner group. The group will complete a survey at respectively 2 (T1), 6 (T2), 11 (T3), 18 (T4), and 26 (T5) as well as 3, 4, 5 and 6 years post loss.

Diagnostic Test: Survey

Interventions

SurveyDIAGNOSTIC_TEST

Completion of surveys with diagnostic measurements (e.g., PGD, depression, anxiety, PTSD).

ChildPartner

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Spousal bereaved individuals (age 25-85) living in the Central Denmark Region plus their adult children (age 18 or above). Eligible participants will be identified through a data extraction of the Danish Civil Registration System (CPR) every sixth week over a period of one year.

You may qualify if:

  • Resident in the following municipalities: Aarhus, Favrskov, Horsens, Norddjurs, Odder, Randers, Silkeborg, Skanderborg, Syddjurs
  • Age 25-85
  • Resident in the following municipalities: Aarhus, Favrskov, Horsens, Norddjurs, Odder, Randers, Silkeborg, Skanderborg, Syddjurs
  • Age 18-85

You may not qualify if:

  • \- Psychiatric inpatients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University, Department of Psychology and Behavioural Sciences, Unit for Bereavement Research

Aarhus, DK-8000, Denmark

Location

Related Publications (1)

  • Komischke-Konnerup KB, Vang ML, Lundorff M, Elklit A, O'Connor M. Do early symptoms of prolonged grief disorder lead to symptoms of posttraumatic stress disorder and depression? A longitudinal register-based study of the two first years of bereavement. J Psychopathol Clin Sci. 2023 Nov;132(8):996-1006. doi: 10.1037/abn0000859. Epub 2023 Aug 3.

Related Links

MeSH Terms

Interventions

Fertility

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Maja O'Connor, MSc PhD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 9, 2017

Study Start

February 7, 2017

Primary Completion

April 1, 2024

Study Completion (Estimated)

April 1, 2030

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations