Prolonged Grief DisorderMAP AsiaNCT03568955
Measurement and Assessment of Prolonged Grief Disorder in Asia
An observational study of Prolonged Grief Disorder, run by University of Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prolonged Grief Disorder
- What is being tested?
- International Prolonged Grief Disorder Scale (IPGDS)
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jun 2018to 2 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- • Severe mental health disorder (e.g. Major depression, suicidality, current schizophrenia),
- currently in-patient,
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Zurich, Department of Psychopathology and Clinical Intervention
Zurich, Canton of Zurich, 8001
About this study
Official title: 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
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.
Read the detailed description
Objectives of the project:
The overall aim of this project is to develop three culturally sensitive measures of grief for use in Switzerland, China and Japan. Three sub-aims are described below:
Substudy 1: Development of the questionnaire Substudy 2: Psychometric Validation of the questionnaire Substudy 3: Relationship between emotional expression and grief The relationship between grief and the expression of emotion will be explored within and across the three cultures.
Outcomes of the project:
Sub-study 1:
- Three new culturally sensitive versions of a Prolonged grief disorder measure (IPGDS) 1) Swiss 2) Japanese 3) Chinese versions: the structure and item content of this measure
- Beta draft of a mobile app version of the IPGDS questionnaire Sub-study 2:
- Psychometric properties of the IPGDs: specific outcomes including statistical confirmation of the reliability (interrater reliability, test/retest, internal consistency) and validity (criterion, content validity, construct validity) of the IPGDs Sub-study 3:
- Identification and documentation of emotional expression differences in Chinese, Japanese and Swiss culture that may impact on assessment of grief and could inform clinical assessment procedure.
- Conditions
- Prolonged Grief Disorder
- Being tested
- International Prolonged Grief Disorder Scale (IPGDS)
- Keywords
- assessment, validation, prolonged grief disorder, cross cultural, questionnaire
- Medical subject headings
- Prolonged Grief Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
International Prolonged Grief Disorder Scale (IPGDS)Diagnostic test
Assessment measure for Prolonged Grief disorder based on the ICD-11 (International Classification of Disorders) criteria for PGD (Prolonged Grief Disorder). 15 items
| Study group | Role | What they receive |
|---|---|---|
| Swiss Bereaved | Adults from the Swiss population who have lost a loved one at least 6 months to 10 years prior to testing Receives: Diagnostic Test: International Prolonged Grief Disorder Scale (IPGDS) | |
| Japanese Bereaved | Adults from the Japanese population who have lost a loved one at least 6 months to 10 years prior to testing Receives: Diagnostic Test: International Prolonged Grief Disorder Scale (IPGDS) | |
| Chinese Bereaved | Adults from the Chinese population who have lost a loved one at least 6 months to 10 years prior to testing Receives: Diagnostic Test: International Prolonged Grief Disorder Scale (IPGDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (6)
Emotional control beliefs about grief scale (ECBG)
Emotion Control Beliefs scale adapted for grief:
Emotion Control Values on Grief was developed from the existing Emotion Control Values (ECV: Mauss et al., 2010) and adapted to the emotion control of grief. It comprises nine items: (1) "People should not cry a lot when grieving"; (2) "It is helpful to cry a lot when grieving"; (3) "People should not express positive emotions when grieving"; (4) "People should not express negative emotions when grieving"; (5) "It is appropriate to express negative emotions when grieving"; (6) "It is appropriate to express positive emotions when grieving"; (7) "People in general should control their emotions more when grieving"; (8) "It is helpful to express negative emotions when grieving"; (9) "It is helpful to express positive emotions when grieving".
Measured: 36 months
Emotion Regulation Questionnaire (ERQ)
Emotion Regulation Questionnaire The 10-item Emotion Regulation Questionnaire (ERQ) includes two dimensions: cognitive re-appraisal and expression suppression (Gross \& Jone, 2003). Each item is rated from from 1 (strongly disagree) to 7 (strongly agree). A higher score indicates a higher frequency to use emotion regulation strategies.
Measured: 36 months
Emotional regulation repertoire(ERR)
Emotion Regulation Repertoire The Emotion Regulation Repertoire (ERR) was developed to assess how close others respond to participants' intense feelings and emotions. For each network member listed in the Social Net-work Index, participants choose from a list of 19 items how the particular network members usually or most often responds to their strong emotions ("This person _____ when I have strong feelings."). Regulation strategies included in the list comprise, amongst others, advises me, understands me, and vents with me. In addition, participants will indicate how their deceased loved one used to re-spond to their emotions.
Measured: 36 months
The social network inventory
Social Network Index The Social Network Index (SNI) was developed and adapted from the existing Social Network Index (SNI: Cohen et al., 1997) in order to tailor it towards social network characteristics of be-reaved individuals. It comprises fourteen items regarding participants' network members including family members, friends, grief support group members, and online contacts. Participants are asked to identify how many network members they feel close to (0-7), and which one of their network members they see or talk to at least once every two weeks (by indicating thei first name and initial for last name).
Measured: 36 months
Idiographic Interview task
Idiographic Interview task (Diminich \& Bonanno, 2014) Participants will discuss their relationships with the deceased and current attachment figure in the context of conflict and intimacy will be conducted. Self-reported affect, emotional word use, and facial coding will be measured and compared between groups.
Participants will be informed that there were no correct answers and that interviewers will be interested in what their particular experiences might be like. Participants will be asked to recall and recount in a fixed order, specific events in which there is: conflict with the deceased; intimacy with the deceased; conflict with other current attachment, and intimacy with other current attachment. The interviewer will halt participant's recounting of the event after 3 minutes.
Measured: 36 months
Positive and Negative Affect Scale
Positive and Negative Affect Scales After each interview topic, participants will be asked to rate using a 5-point Likert scale from 1(very slightly) to 5 (extremely) the extent to which they feel a number of emotions using the Posi-tive and Negative Affect Schedule (PANAS: Watson et al., 1988). The PANAS is composed of two scales, 10 items for positive emotion (interested, excited, strong, enthusiastic, proud, alert, inspired, determined, attentive, active) and 10 items for negative emotion (distressed, upset, guilty, scared, hostile, irritable, ashamed, nervous, jittery, afraid).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start30 Jun 2018
- Primary completion1 Jul 2018
- Study completion2 Jul 2018
Why it stopped: This is no longer considered a clinical trial as per the Kantonial Ethics Committee in Zurich, CH
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolonged Grief DisorderStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Jichi Medical University, Beijing Normal University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568955
- Sponsor's protocol ID
- MAPAsia2018
- Acronym
- MAP Asia
- Status last verified
- Oct 2018
- First submitted
- 1 Jun 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33049644
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03568955
- Acronym / sponsor ID
- MAP Asia / MAPAsia2018
- Conditions
- Prolonged Grief Disorder
- Keywords
- assessment, validation, prolonged grief disorder, cross cultural, questionnaire
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This is no longer considered a clinical trial as per the Kantonial Ethics Committee in Zurich, CH
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Jichi Medical University, Beijing Normal University
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives of the project:
The overall aim of this project is to develop three culturally sensitive measures of grief for use in Switzerland, China and Japan. Three sub-aims are described below:
Substudy 1: Development of the questionnaire Substudy 2: Psychometric Validation of the questionnaire Substudy 3: Relationship between emotional expression and grief The relationship between grief and the expression of emotion will be explored within and across the three cultures.
Outcomes of the project:
Sub-study 1:
- Three new culturally sensitive versions of a Prolonged grief disorder measure (IPGDS) 1) Swiss 2) Japanese 3) Chinese versions: the structure and item content of this measure
- Beta draft of a mobile app version of the IPGDS questionnaire Sub-study 2:
- Psychometric properties of the IPGDs: specific outcomes including statistical confirmation of the reliability (interrater reliability, test/retest, internal consistency) and validity (criterion, content validity, construct validity) of the IPGDs Sub-study 3:
- Identification and documentation of emotional expression differences in Chinese, Japanese and Swiss culture that may impact on assessment of grief and could inform clinical assessment procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Swiss Bereaved | – | Diagnostic Test: International Prolonged Grief Disorder Scale (IPGDS)Adults from the Swiss population who have lost a loved one at least 6 months to 10 years prior to testing |
| Japanese Bereaved | – | Diagnostic Test: International Prolonged Grief Disorder Scale (IPGDS)Adults from the Japanese population who have lost a loved one at least 6 months to 10 years prior to testing |
| Chinese Bereaved | – | Diagnostic Test: International Prolonged Grief Disorder Scale (IPGDS)Adults from the Chinese population who have lost a loved one at least 6 months to 10 years prior to testing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Swiss, Japanese, Chinese nationality or identity
Key exclusion criteria (2 listed)
- • Severe mental health disorder (e.g. Major depression, suicidality, current schizophrenia),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| International Prolonged Grief Disorder Scale (IPGDS)Assessment measure for Prolonged Grief disorder based on the ICD-11 (International Classification of Disorders) criteria for PGD (Prolonged Grief Disorder). 15 items | Diagnostic test | Chinese Bereaved, Japanese Bereaved, Swiss Bereaved |
Primary outcome
Development and validity of the International Prolonged Grief Disorder Scale (IPGDS), A questionnaire
Time frame: 24 months
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.
6 secondary outcomes
Emotional control beliefs about grief scale (ECBG)
Time frame: 36 months
Emotion Regulation Questionnaire (ERQ)
Time frame: 36 months
Emotional regulation repertoire(ERR)
Time frame: 36 months
The social network inventory
Time frame: 36 months
Idiographic Interview task
Time frame: 36 months
Positive and Negative Affect Scale
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Derived from this study: PubMed 33049644Stelzer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolonged Grief Disorder, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and validity of the International Prolonged Grief Disorder Scale (IPGDS), A questionnaire (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03568955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.