Viewing Study NCT03049007



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Last Modification Date: 2024-10-26 @ 12:18 PM
Study NCT ID: NCT03049007
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-11-29
First Post: 2017-02-07

Brief Title: The Aarhus Bereavement Study
Sponsor: University of Aarhus
Organization: University of Aarhus

Study Overview

Official Title: The Aarhus Bereavement Study - a Prospective Study on Natural and Prolonged Grief Reactions in the Adult Population
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: TABS
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 eg sadness guilt anger denial blame difficulty accepting the death The disorder has been admitted as an official diagnosis in the World Heath Organizations 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 eg high score on suicidal ideation they will be contacted by the researchers and a suicide risk screening is performed

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None