GriefTABSNCT03049007
The Aarhus Bereavement Study
An observational study of Grief, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Grief
- What is being tested?
- Survey
- How many people
- 1,243 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Feb 2017to 1 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Resident in the following municipalities: Aarhus, Favrskov, Horsens, Norddjurs, Odder, Randers, Silkeborg, Skanderborg, Syddjurs
- Age 25-85
- Has lost a partner or spouse within the last 5 weeks from inclusion
- Resident in the following municipalities: Aarhus, Favrskov, Horsens, Norddjurs, Odder, Randers, Silkeborg, Skanderborg, Syddjurs
- Age 18-85
- Has lost a parent or step-parent within the last 5 weeks from inclusion
Who cannot join
- Psychiatric inpatients
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department of Psychology and Behavioural Sciences, Unit for Bereavement Research
Aarhus, DK-8000
About this study
Official title: The Aarhus Bereavement Study - a Prospective Study on Natural and Prolonged Grief Reactions in the Adult Population
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.
Read the detailed description
BACKGROUND:
Prolonged grief disorder (PGD) is a new diagnosis that may occur after the death of a partner, parent, child, or other person close to the bereaved. PGD is characterized by a persistent and pervasive grief response including longing for the deceased or persistent preoccupation with the deceased accompanied by intense emotional pain (e.g. sadness, guilt, anger, denial, blame, difficulty accepting the death). The disorder has been admitted as an official diagnosis in the World Heath Organization's newest diagnostic manual (International Classification of Diseases, 11th revision; ICD-11). When introducing the diagnosis in ICD-11, health care services are obliged to identify and treat PGD.
PURPOSE AND AIMS:
The primary purpose of the study is to prepare healthcare services to use the diagnosis of PGD. More specifically, the project aims to determine the frequency and structure of PDG in a population sample of bereaved spouses and their adult children. It will also identify early predictors of PGD and common trajectories of natural and prolonged grief as well as investigate the specificity of PGD in relation to other common loss-related reactions. Finally, the project will also assess the socioeconomic costs of PGD by analyzing health data registries.
HYPOTHESES:
Based on existing bereavement literature and empirical research, the project explores the following hypotheses:
- High rumination, low levels of mental and physical health, loss of spouse versus loss of parent, and presence of psychopathology at time of loss (T1) will predict degree of PGD symptoms among the bereaved at 6 (T2) and 11 (T3) months post-loss.
- The majority of bereaved individuals will exhibit a grief trajectory with a gradual decline in PGD symptoms over time, while a significant minority of bereaved individuals will show a trajectory with high levels of PGD symptoms across all measured time-points.
- PGD, PTSD, depression, and anxiety will be distinct constructs.
On a more genereal level. trajectories of grief and in line with the aim of this study, structure and frequency of prolonged grief disorder, and the relationship with PGD and other forms of complicated grief reactions will be analyzed across the timepoints and factors related to grief will be investigated.
PARTICIPANTS AND PROCEDURES:
Individuals (age 25-85) will be consecutively recruited through the Danish Civil Personal Registry (CPR) from the Central Region of Denmark. After the loss, participants are contacted with a letter of condolence and a brief introduction to the study. Two months post-loss, potential participants are telephoned and invited to participate in the study. Participants are asked to complete self-report questionnaires, respectively at 2 (T1), 6 (T2), 11 (T3), 18 (T4), 26 (T5), months and continue with data collections at 3 (T6), 4 (T7), 5 (T8) and 6 (T9) years post-loss. To meet different needs, participants can choose to fill in the questionnaire online or by postal service.
Bereaved individuals constitute a highly vulnerable group with a heightened risk of suicide, social isolation, depression, etc. In the event, participants appear suicidal or particularly distressed (e.g. high score on suicidal ideation) they will be contacted by the researchers and a suicide risk screening is performed.
- Conditions
- Grief
- Being tested
- Survey
- Keywords
- bereavement, natural grief, prolonged grief, complicated grief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyDiagnostic test
Completion of surveys with diagnostic measurements (e.g., PGD, depression, anxiety, PTSD).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged grief
Changes in prolonged grief symptoms measured using the Prolonged Grief Disorder-13 (PG-13; Prigerson et al., 2009)
Measured: 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)
Measured: 2, 6, 11, 18, and 26 months post-loss
Secondary outcomes (5)
Depression
Symptoms of depression are measured using the Center for Epidemiologic Studies Short Depression Scale (CES-D 10; Radloff, 1977)
Measured: 2, 6, 11, 18, and 26 months post-loss
Generalized anxiety
Symptoms of generalized anxiety are measured using the Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)
Measured: 2, 6, 11, 18, and 26 months post-loss
Post-traumatic stress
Symptoms of post-traumatic stress are measured using the PTSD checklist - Civilian Version (PCL-C; Ruggiero et al., 1999)
Measured: 2, 6, 11, 18, and 26 months post-loss
Well-being
Levels of well-being are measured using the World Health Organization-5 (WHO-5; Heun et al., 2001)
Measured: 2, 6, 11, 18, and 26 months post-loss
Mental and physical health
Levels of mental and physical health are measured using the 12-Item Short Form Health Survey (SF-12; Ware et al., 1996)
Measured: 2, 18, and 26 months post-loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start7 Feb 2017
- Primary completion1 Apr 2024
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GriefStudies 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
- Prospective
- Enrolment
- 1,243 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maja O'Connor, MSc PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049007
- Sponsor's protocol ID
- AU2017
- Acronym
- TABS
- Status last verified
- Aug 2025
- First submitted
- 7 Feb 2017
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37535580
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
- The Aarhus Bereavement Study - a Prospective Study on Natural and Prolonged Grief Reactions in the Adult Population
- ClinicalTrials.gov ID
- NCT03049007
- Acronym / sponsor ID
- TABS / AU2017
- Conditions
- Grief
- Keywords
- bereavement, natural grief, prolonged grief, complicated grief
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,243 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- 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.
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.
Detailed description
BACKGROUND:
Prolonged grief disorder (PGD) is a new diagnosis that may occur after the death of a partner, parent, child, or other person close to the bereaved. PGD is characterized by a persistent and pervasive grief response including longing for the deceased or persistent preoccupation with the deceased accompanied by intense emotional pain (e.g. sadness, guilt, anger, denial, blame, difficulty accepting the death). The disorder has been admitted as an official diagnosis in the World Heath Organization's newest diagnostic manual (International Classification of Diseases, 11th revision; ICD-11). When introducing the diagnosis in ICD-11, health care services are obliged to identify and treat PGD.
PURPOSE AND AIMS:
The primary purpose of the study is to prepare healthcare services to use the diagnosis of PGD. More specifically, the project aims to determine the frequency and structure of PDG in a population sample of bereaved spouses and their adult children. It will also identify early predictors of PGD and common trajectories of natural and prolonged grief as well as investigate the specificity of PGD in relation to other common loss-related reactions. Finally, the project will also assess the socioeconomic costs of PGD by analyzing health data registries.
HYPOTHESES:
Based on existing bereavement literature and empirical research, the project explores the following hypotheses:
- High rumination, low levels of mental and physical health, loss of spouse versus loss of parent, and presence of psychopathology at time of loss (T1) will predict degree of PGD symptoms among the bereaved at 6 (T2) and 11 (T3) months post-loss.
- The majority of bereaved individuals will exhibit a grief trajectory with a gradual decline in PGD symptoms over time, while a significant minority of bereaved individuals will show a trajectory with high levels of PGD symptoms across all measured time-points.
- PGD, PTSD, depression, and anxiety will be distinct constructs.
On a more genereal level. trajectories of grief and in line with the aim of this study, structure and frequency of prolonged grief disorder, and the relationship with PGD and other forms of complicated grief reactions will be analyzed across the timepoints and factors related to grief will be investigated.
PARTICIPANTS AND PROCEDURES:
Individuals (age 25-85) will be consecutively recruited through the Danish Civil Personal Registry (CPR) from the Central Region of Denmark. After the loss, participants are contacted with a letter of condolence and a brief introduction to the study. Two months post-loss, potential participants are telephoned and invited to participate in the study. Participants are asked to complete self-report questionnaires, respectively at 2 (T1), 6 (T2), 11 (T3), 18 (T4), 26 (T5), months and continue with data collections at 3 (T6), 4 (T7), 5 (T8) and 6 (T9) years post-loss. To meet different needs, participants can choose to fill in the questionnaire online or by postal service.
Bereaved individuals constitute a highly vulnerable group with a heightened risk of suicide, social isolation, depression, etc. In the event, participants appear suicidal or particularly distressed (e.g. high score on suicidal ideation) they will be contacted by the researchers and a suicide risk screening is performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partner | – | Diagnostic Test: SurveySpousal 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. |
| Child | – | Diagnostic Test: SurveyParental 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Resident in the following municipalities: Aarhus, Favrskov, Horsens, Norddjurs, Odder, Randers, Silkeborg, Skanderborg, Syddjurs
- Age 25-85
- Has lost a partner or spouse within the last 5 weeks from inclusion
- Resident in the following municipalities: Aarhus, Favrskov, Horsens, Norddjurs, Odder, Randers, Silkeborg, Skanderborg, Syddjurs
- Age 18-85
Key exclusion criteria (1 listed)
- Psychiatric inpatients
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 |
|---|---|---|
| SurveyCompletion of surveys with diagnostic measurements (e.g., PGD, depression, anxiety, PTSD). | Diagnostic test | Child, Partner |
Primary outcome
Prolonged grief
Time frame: 2, 6, 11, 18, and 26 months post-loss
Changes in prolonged grief symptoms measured using the Prolonged Grief Disorder-13 (PG-13; Prigerson et al., 2009)
Complicated grief
Time frame: 2, 6, 11, 18, and 26 months post-loss
Changes in complicated grief symptoms measured using the Inventory of Complicated Grief Revised (ICG-R; Prigerson \& Jacobs, 2001)
5 secondary outcomes
Depression
Time frame: 2, 6, 11, 18, and 26 months post-loss
Generalized anxiety
Time frame: 2, 6, 11, 18, and 26 months post-loss
Post-traumatic stress
Time frame: 2, 6, 11, 18, and 26 months post-loss
Well-being
Time frame: 2, 6, 11, 18, and 26 months post-loss
Mental and physical health
Time frame: 2, 18, and 26 months post-loss
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Derived from this study: PubMed 37535580Komischke-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.
- Webpage with information on the research unit conduction the studyLink provided by the sponsor.
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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, MSc PhD principal investigator
University of Aarhus
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 Grief, 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 6 inclusion and 1 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: under way, not looking for participants, 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?
This study is still under way. Results are not available in the source record yet.
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 (time frame: 2, 6, 11, 18, and 26 months post-loss). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03049007, which also lists 1 linked publication.
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.