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NCT Number: NCT03049007

The Aarhus Bereavement Study

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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Aarhus, DK-8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey

Diagnostic Test

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

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Depression

    Time frame: 2, 6, 11, 18, and 26 months post-loss

    Symptoms of depression are measured using the Center for Epidemiologic Studies Short Depression Scale (CES-D 10; Radloff, 1977)

  2. Generalized anxiety

    Time frame: 2, 6, 11, 18, and 26 months post-loss

    Symptoms of generalized anxiety are measured using the Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)

  3. Post-traumatic stress

    Time frame: 2, 6, 11, 18, and 26 months post-loss

    Symptoms of post-traumatic stress are measured using the PTSD checklist - Civilian Version (PCL-C; Ruggiero et al., 1999)

  4. Well-being

    Time frame: 2, 6, 11, 18, and 26 months post-loss

    Levels of well-being are measured using the World Health Organization-5 (WHO-5; Heun et al., 2001)

  5. Mental and physical health

    Time frame: 2, 18, and 26 months post-loss

    Levels of mental and physical health are measured using the 12-Item Short Form Health Survey (SF-12; Ware et al., 1996)

Other outcomes

  1. Loneliness

    Time frame: 2, 6, 11, 18, and 26 months post-loss

    Levels of loneliness are measured using the Three-Item Loneliness Scale (T-ILS; Hughes, Waite, Hawkley, & Cacioppo, 2004)

  2. Rumination

    Time frame: 2, 6, and 11 months post-loss

    Levels of rumination are measured using the Rumination-Reflection Questionnaire (RRQ; Trapnell & Campbell, 1999)

  3. Social support

    Time frame: 2, 6, and 11 months post-loss

    Levels of social support are measured using the Crisis Social Support scale (CSS; Joseph, Andrews, Williams, & Yule, 1992)

  4. Attachment

    Time frame: 2 months post-loss

    Attachment orientations are measured using the Experiences in Close Relationship Scale - short (ECR; Wei et al., 2007)

  5. Optimism

    Time frame: 2 months post-loss

    Levels of optimism are measured using the Life Orientation Test - Revised (LOT-R; Scheier, Carver, & Bridges, 1994)

  6. Neuroticism

    Time frame: 2 months post-loss

    Levels of neuroticism are measured using the NEO Personality Inventory-Revised - neuroticism only (NEO-PI-R; Costa & McRae, 2004)

  7. Centrality of event

    Time frame: 2, 6, and 11 months post-loss

    Levels of centrality of event are measured using the Centrality of Event Scale (CES; Berntsen & Rubin, 2006)

  8. Emotional expression

    Time frame: 2 months post-loss

    Ability of emotional expression are measured using the Flexible Regulation of Emotional Expression (FREE; Burton & Bonanno, 2015)

  9. Emotion regulation

    Time frame: 2 months post-loss

    Levels of emotion regulation are measured using the Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

The Aarhus Bereavement Study - a Prospective Study on Natural and Prolonged Grief Reactions in the Adult Population

Acronym: TABS

Important dates

Study start
2017
Primary completion
2024
Study completion
2030
First posted
Feb 9, 2017
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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