NCT03568955

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

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

June 30, 2018

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2018

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

1 day

First QC Date

June 1, 2018

Last Update Submit

October 29, 2018

Conditions

Keywords

assessmentvalidationprolonged grief disordercross culturalquestionnaire

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

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

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

Diagnostic Test: International Prolonged Grief Disorder Scale (IPGDS)

Interventions

Assessment measure for Prolonged Grief disorder based on the ICD-11 (International Classification of Disorders) criteria for PGD (Prolonged Grief Disorder). 15 items

Chinese BereavedJapanese BereavedSwiss Bereaved

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

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

Study Sites (1)

University of Zurich, Department of Psychopathology and Clinical Intervention

Zurich, Canton of Zurich, 8001, Switzerland

Location

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.

MeSH Terms

Conditions

Prolonged Grief Disorder

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders
0

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

Locations