Clinical trial NCT03568955: Measurement and Assessment of Prolonged Grief Disorder in Asia
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prolonged Grief Disorder
Keywords: assessment
validation
prolonged grief disorder
cross cultural
questionnaire
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Jichi Medical University
name: Beijing Normal University
First posted: 2018-06-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.

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:

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
2. Beta draft of a mobile app version of the IPGDS questionnaire

   Sub-study 2:
3. 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:
4. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* • Severe mental health disorder (e.g. Major depression, suicidality, current schizophrenia),

  * currently in-patient,

Primary outcomes:
measure: Development and validity of the International Prolonged Grief Disorder Scale (IPGDS), A questionnaire
timeFrame: 24 months
Secondary outcomes:
measure: Emotional control beliefs about grief scale (ECBG)
timeFrame: 36 months
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: 36 months
measure: Emotional regulation repertoire(ERR)
timeFrame: 36 months
measure: The social network inventory
timeFrame: 36 months
measure: Idiographic Interview task
timeFrame: 36 months
measure: Positive and Negative Affect Scale
timeFrame: 36 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University of Zurich, Department of Psychopathology and Clinical Intervention
state: Zurich
Study officials:
References:
citation: 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.