The Aarhus Bereavement Study

Grief Clinical Trial

— TABS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03049007
• Other study ID #: AU2017
• Status: Active, not recruiting
• Start date: February 7, 2017
• Est. completion date: April 1, 2024

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1243
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Grief

Intervention

Diagnostic Test:
• Survey
Completion of surveys with diagnostic measurements (e.g., PGD, depression, anxiety, PTSD).

Locations

Country	Name	City	State
Denmark	Aarhus University, Department of Psychology and Behavioural Sciences, Unit for Bereavement Research	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Loneliness	Levels of loneliness are measured using the Three-Item Loneliness Scale (T-ILS; Hughes, Waite, Hawkley, & Cacioppo, 2004)	2, 6, 11, 18, and 26 months post-loss
Other	Rumination	Levels of rumination are measured using the Rumination-Reflection Questionnaire (RRQ; Trapnell & Campbell, 1999)	2, 6, and 11 months post-loss
Other	Social support	Levels of social support are measured using the Crisis Social Support scale (CSS; Joseph, Andrews, Williams, & Yule, 1992)	2, 6, and 11 months post-loss
Other	Attachment	Attachment orientations are measured using the Experiences in Close Relationship Scale - short (ECR; Wei et al., 2007)	2 months post-loss
Other	Optimism	Levels of optimism are measured using the Life Orientation Test - Revised (LOT-R; Scheier, Carver, & Bridges, 1994)	2 months post-loss
Other	Neuroticism	Levels of neuroticism are measured using the NEO Personality Inventory-Revised - neuroticism only (NEO-PI-R; Costa & McRae, 2004)	2 months post-loss
Other	Centrality of event	Levels of centrality of event are measured using the Centrality of Event Scale (CES; Berntsen & Rubin, 2006)	2, 6, and 11 months post-loss
Other	Emotional expression	Ability of emotional expression are measured using the Flexible Regulation of Emotional Expression (FREE; Burton & Bonanno, 2015)	2 months post-loss
Other	Emotion regulation	Levels of emotion regulation are measured using the Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)	2 months post-loss
Primary	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
Primary	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	Depression	Symptoms of depression are measured using the Center for Epidemiologic Studies Short Depression Scale (CES-D 10; Radloff, 1977)	2, 6, 11, 18, and 26 months post-loss
Secondary	Generalized anxiety	Symptoms of generalized anxiety are measured using the Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)	2, 6, 11, 18, and 26 months post-loss
Secondary	Post-traumatic stress	Symptoms of post-traumatic stress are measured using the PTSD checklist - Civilian Version (PCL-C; Ruggiero et al., 1999)	2, 6, 11, 18, and 26 months post-loss
Secondary	Well-being	Levels of well-being are measured using the World Health Organization-5 (WHO-5; Heun et al., 2001)	2, 6, 11, 18, and 26 months post-loss
Secondary	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)	2, 18, and 26 months post-loss

External Links

•   Webpage with information on the research unit conduction the study