Clinical trial NCT03049007: The Aarhus Bereavement Study
Official title: The Aarhus Bereavement Study - a Prospective Study on Natural and Prolonged Grief Reactions in the Adult Population
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Grief
Keywords: bereavement
natural grief
prolonged grief
complicated grief
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 1243
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.

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:

1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria, partner:

* 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

Inclusion Criteria, child:

* 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

Exclusion Criteria, all:

- Psychiatric inpatients

Primary outcomes:
measure: Prolonged grief
timeFrame: 2, 6, 11, 18, and 26 months post-loss
measure: Complicated grief
timeFrame: 2, 6, 11, 18, and 26 months post-loss
Secondary outcomes:
measure: Depression
timeFrame: 2, 6, 11, 18, and 26 months post-loss
measure: Generalized anxiety
timeFrame: 2, 6, 11, 18, and 26 months post-loss
measure: Post-traumatic stress
timeFrame: 2, 6, 11, 18, and 26 months post-loss
measure: Well-being
timeFrame: 2, 6, 11, 18, and 26 months post-loss
measure: Mental and physical health
timeFrame: 2, 18, and 26 months post-loss
Other outcomes:
measure: Loneliness
timeFrame: 2, 6, 11, 18, and 26 months post-loss
measure: Rumination
timeFrame: 2, 6, and 11 months post-loss
measure: Social support
timeFrame: 2, 6, and 11 months post-loss
measure: Attachment
timeFrame: 2 months post-loss
measure: Optimism
timeFrame: 2 months post-loss
measure: Neuroticism
timeFrame: 2 months post-loss
measure: Centrality of event
timeFrame: 2, 6, and 11 months post-loss
measure: Emotional expression
timeFrame: 2 months post-loss
measure: Emotion regulation
timeFrame: 2 months post-loss
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department of Psychology and Behavioural Sciences, Unit for Bereavement Research
Study officials:
affiliation: University of Aarhus
name: Maja O'Connor, MSc PhD
role: PRINCIPAL_INVESTIGATOR
References: