Measurement and Assessment of Prolonged Grief Disorder in Asia

Prolonged Grief Disorder Clinical Trial

— MAP 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03568955
• Other study ID #: MAPAsia2018
• Status: Withdrawn
• Start date: June 30, 2018
• Est. completion date: July 2, 2018

Study information

• Verified date: October 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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,

Related Conditions & MeSH terms

• Disease
• Prolonged Grief Disorder

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Switzerland	University of Zurich, Department of Psychopathology and Clinical Intervention	Zürich	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Beijing Normal University, Jichi Medical University

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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".	36 months
Secondary	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.	36 months
Secondary	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.	36 months
Secondary	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).	36 months
Secondary	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.	36 months
Secondary	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).	36 months