- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03049007
The Aarhus Bereavement Study (TABS)
The Aarhus Bereavement Study - a Prospective Study on Natural and Prolonged Grief Reactions in the Adult Population
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aarhus, Denmark, DK-8000
- Aarhus University, Department of Psychology and Behavioural Sciences, Unit for Bereavement Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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Completion of surveys with diagnostic measurements (e.g., PGD, depression, anxiety, PTSD).
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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.
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Completion of surveys with diagnostic measurements (e.g., PGD, depression, anxiety, PTSD).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prolonged grief
Time Frame: 2, 6, 11, 18, and 26 months post-loss
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Changes in prolonged grief symptoms measured using the Prolonged Grief Disorder-13 (PG-13; Prigerson et al., 2009)
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2, 6, 11, 18, and 26 months post-loss
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Complicated grief
Time Frame: 2, 6, 11, 18, and 26 months post-loss
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Changes in complicated grief symptoms measured using the Inventory of Complicated Grief Revised (ICG-R; Prigerson & Jacobs, 2001)
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2, 6, 11, 18, and 26 months post-loss
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Depression
Time Frame: 2, 6, 11, 18, and 26 months post-loss
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Symptoms of depression are measured using the Center for Epidemiologic Studies Short Depression Scale (CES-D 10; Radloff, 1977)
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2, 6, 11, 18, and 26 months post-loss
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Generalized anxiety
Time Frame: 2, 6, 11, 18, and 26 months post-loss
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Symptoms of generalized anxiety are measured using the Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006)
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2, 6, 11, 18, and 26 months post-loss
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Post-traumatic stress
Time Frame: 2, 6, 11, 18, and 26 months post-loss
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Symptoms of post-traumatic stress are measured using the PTSD checklist - Civilian Version (PCL-C; Ruggiero et al., 1999)
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2, 6, 11, 18, and 26 months post-loss
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Well-being
Time Frame: 2, 6, 11, 18, and 26 months post-loss
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Levels of well-being are measured using the World Health Organization-5 (WHO-5; Heun et al., 2001)
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2, 6, 11, 18, and 26 months post-loss
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Mental and physical health
Time Frame: 2, 18, and 26 months post-loss
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Levels of mental and physical health are measured using the 12-Item Short Form Health Survey (SF-12; Ware et al., 1996)
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2, 18, and 26 months post-loss
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Loneliness
Time Frame: 2, 6, 11, 18, and 26 months post-loss
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Levels of loneliness are measured using the Three-Item Loneliness Scale (T-ILS; Hughes, Waite, Hawkley, & Cacioppo, 2004)
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2, 6, 11, 18, and 26 months post-loss
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Rumination
Time Frame: 2, 6, and 11 months post-loss
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Levels of rumination are measured using the Rumination-Reflection Questionnaire (RRQ; Trapnell & Campbell, 1999)
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2, 6, and 11 months post-loss
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Social support
Time Frame: 2, 6, and 11 months post-loss
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Levels of social support are measured using the Crisis Social Support scale (CSS; Joseph, Andrews, Williams, & Yule, 1992)
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2, 6, and 11 months post-loss
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Attachment
Time Frame: 2 months post-loss
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Attachment orientations are measured using the Experiences in Close Relationship Scale - short (ECR; Wei et al., 2007)
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2 months post-loss
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Optimism
Time Frame: 2 months post-loss
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Levels of optimism are measured using the Life Orientation Test - Revised (LOT-R; Scheier, Carver, & Bridges, 1994)
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2 months post-loss
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Neuroticism
Time Frame: 2 months post-loss
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Levels of neuroticism are measured using the NEO Personality Inventory-Revised - neuroticism only (NEO-PI-R; Costa & McRae, 2004)
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2 months post-loss
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Centrality of event
Time Frame: 2, 6, and 11 months post-loss
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Levels of centrality of event are measured using the Centrality of Event Scale (CES; Berntsen & Rubin, 2006)
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2, 6, and 11 months post-loss
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Emotional expression
Time Frame: 2 months post-loss
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Ability of emotional expression are measured using the Flexible Regulation of Emotional Expression (FREE; Burton & Bonanno, 2015)
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2 months post-loss
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Emotion regulation
Time Frame: 2 months post-loss
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Levels of emotion regulation are measured using the Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)
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2 months post-loss
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maja O'Connor, MSc PhD, University of Aarhus
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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