Study Stopped
This is no longer considered a clinical trial as per the Kantonial Ethics Committee in Zurich, CH
Measurement and Assessment of Prolonged Grief Disorder in Asia
MAP Asia
Development and Validation of an Assessment Measure for Prolonged Grief Disorder for Swiss, Japanese and Chinese Bereaved Adults: an Examination of Cultural Differences in Symptoms, Emotion Expression and Regulation
1 other identifier
observational
N/A
1 country
1
Brief Summary
The overall project includes three sub-studies. Sub-Study I aims to develop the content of a new cultural sensitive grief questionnaire (International Prolonged Grief Disorder Scale, IPGDS Killikelly and Maercker, 2018) through interviews and focus groups with key (expert) informants and bereaved participants from Japan, Switzerland and China. The content will be piloted in paper and mobile app format. Sub - Study II aims to validate the new paper and mobile questionnaire in 200 participants from each culture using a battery of questionnaires and psychometric assessment. Sub-Study III will explore the relationship between grief and the cultural expression or repression of emotion. This will involve a battery of questionnaires about emotional expression and a short idiographic interview task administered to Swiss, Japanese and Chinese bereaved participants in paper and online format.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedStudy Start
First participant enrolled
June 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2018
CompletedOctober 31, 2018
October 1, 2018
1 day
June 1, 2018
October 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Development and validity of the International Prolonged Grief Disorder Scale (IPGDS), A questionnaire
refinement and psychometric properties of the IPGDS (International Prolonged Grief Disorder Scale): Prolonged grief symptoms will be evaluated through the ICD-11 Prolonged Grief Disorder Scale (IPGDS) (Killikelly and Maercker, 2018). This scale comprises 14 previously used items integrating the PG-13 (Prigerson, Vanderwerker and Maciejewski, 2008) and the SCI-CG (Bui et al., 2015). The participants will be requested to describe how often they had felt preoccupation, yearning and symptoms of emotional distress over the past month because of loss of a loved one, using a 5-point scale: 1 = almost never (less than once a month), 2 = rarely (monthly), 3 = sometimes (weekly), 4 = often (daily), and 5 = always (several times a day). The English, Japanese and Chinese versions of the IPGDs will be translated and back translated following standard protocol (Mollica et al., 1992). The scale will be in paper and online format and can be completed in 5-10 minutes.
24 months
Secondary Outcomes (6)
Emotional control beliefs about grief scale (ECBG)
36 months
Emotion Regulation Questionnaire (ERQ)
36 months
Emotional regulation repertoire(ERR)
36 months
The social network inventory
36 months
Idiographic Interview task
36 months
- +1 more secondary outcomes
Study Arms (3)
Swiss Bereaved
Adults from the Swiss population who have lost a loved one at least 6 months to 10 years prior to testing
Japanese Bereaved
Adults from the Japanese population who have lost a loved one at least 6 months to 10 years prior to testing
Chinese Bereaved
Adults from the Chinese population who have lost a loved one at least 6 months to 10 years prior to testing
Interventions
Assessment measure for Prolonged Grief disorder based on the ICD-11 (International Classification of Disorders) criteria for PGD (Prolonged Grief Disorder). 15 items
Eligibility Criteria
The study population will be bereaved adult participants from the age of 18 to 65. We will recruit 20 key informants from each country for the qualitative interviews. 150-200 Swiss bereaved, 150-200 Japanese bereaved, 150-200 Chinese bereaved will complete the questionnaires.
You may qualify if:
- Swiss, Japanese, Chinese nationality or identity
- English, German, Japanese, Cantonese or Mandarin speaking
- Male and Female subjects 18 years to 75 years of age
- Written informed consent by the participant after information about the project
- Loss of a loved one (family or friend) at least 6 months prior, at most 10 years prior
You may not qualify if:
- Severe mental health disorder (e.g. Major depression, suicidality, current schizophrenia),
- currently in-patient,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- Jichi Medical Universitycollaborator
- Beijing Normal Universitycollaborator
Study Sites (1)
University of Zurich, Department of Psychopathology and Clinical Intervention
Zurich, Canton of Zurich, 8001, Switzerland
Related Publications (1)
Stelzer EM, Holtge J, Zhou N, Maercker A, Killikelly C. Cross-cultural generalizability of the ICD-11 PGD symptom network: Identification of central symptoms and culturally specific items across German-speaking and Chinese bereaved. Compr Psychiatry. 2020 Nov;103:152211. doi: 10.1016/j.comppsych.2020.152211. Epub 2020 Sep 30.
PMID: 33049644DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2018
First Posted
June 26, 2018
Study Start
June 30, 2018
Primary Completion
July 1, 2018
Study Completion
July 2, 2018
Last Updated
October 31, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share