UMIN-ICDS Clinical Trial

Public title

Reliability and Validity of the Japanese Version of the Structured Clinical Interview for Prolonged Grief Disorder (SCIP)

Acronym

Reliability and Validity of the Japanese Version of the Structured Clinical Interview for Prolonged Grief Disorder (SCIP)

Scientific Title

Reliability and Validity of the Japanese Version of the Structured Clinical Interview for Prolonged Grief Disorder (SCIP)

Scientific Title:Acronym

Reliability and Validity of the Japanese Version of the Structured Clinical Interview for Prolonged Grief Disorder (SCIP)

Region

Japan

Condition

Prolonged Grief Disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to standardize the Japanese version of the Structured Clinical Interview for Prolonged Grief Disorder (SCIP) through an examination of its reliability and validity among participants in Japan.

Basic objectives2

Others

Basic objectives -Others

The purpose of this study is to assess the reliability of the SCIP through internal consistency and inter-rater agreement, and to evaluate its validity through convergent and discriminant validity.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The Japanese version of the Structured Clinical Interview for Prolonged Grief Disorder (SCIP)

Key secondary outcomes

Japanese version of the Prolonged Grief Disorder scale: PG-13-Revised (PG-13-R)
Japanese version of the Prolonged Grief Disorder scale: Inventory of Complicated Grief (ICG)
Japanese version of the depression scale: Patient Health Questionnaire-9 (PHQ-9)
Japanese version of the posttraumatic stress disorder scale: PTSD Checklist for DSM-5 (PCL-5)
Japanese version of the generalized anxiety disorder scale: Generalized Anxiety Disorder-7 (GAD-7)
Japanese version of the quality of life scale: EuroQol-5 Dimensions-5 Level (EQ-5D-5L)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

79

years-old

>=

Gender

Male and Female

Key inclusion criteria

Individuals who have experienced the loss of a significant other (e.g., a family member, friend, or partner)
Individuals whose bereavement occurred between 1 and 10 years ago
Men and women aged between 18 and 79 years at the time of consent
Individuals who have provided written informed consent to participate in the study

Key exclusion criteria

Individuals who are unable to provide informed consent due to impaired decisional capacity
Individuals with insufficient comprehension of the Japanese language
Individuals judged to have severe suicidal ideation
Individuals deemed ineligible for the study by the investigators or other research personnel

Target sample size

150

Name of lead principal investigator

1st name	Yuko
Middle name
Last name	Toshishige

Organization

Nagoya City University

Division name

Graduate School of Medical Sciences Psychiatry and Cognitive-Behavioral Medicine

Zip code

467-8601

Address

1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan

TEL

052-853-8271

Email

yuu0323uchi@gmail.com

Name of contact person

1st name	Yuko
Middle name
Last name	Toshishige

Organization

Nagoya City University

Division name

Graduate School of Medical Sciences Psychiatry and Cognitive-Behavioral Medicine

Zip code

467-8601

Address

1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan

TEL

052-853-8271

Homepage URL

Email

yuu0323uchi@gmail.com

Institute

Nagoya City University

Institute

Department

Personal name

Yuko Toshishige

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nagoya City University Institutional Review Board

Address

1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan

Tel

052-851-5511

Email

clinical_research@med.nagoya-cu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

名古屋市立大学病院（愛知県）、武蔵野大学心理臨床センター・認知行動療法研究所（東京都）、兵庫県こころのケアセンター（兵庫県）

Date of disclosure of the study information

2026

Year

11

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2025

Year

06

Month

08

Day

Date of IRB

2025

Year

08

Month

27

Day

Anticipated trial start date

2025

Year

08

Month

30

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. Study Design
Observational cross-sectional study

2. Recruitment Method
Potential participants, including outpatients and their family members at Nagoya City University Hospital, individuals attending the Grief Care Outpatient Clinic at Nagoya City University Hospital and their family members, outpatients at the Hyogo Institute for Traumatic Stress, and individuals attending the Psychological Counseling Center or the Institute of Cognitive Behavioral Therapy at Musashino University, will be invited to participate in the study through the distribution of recruitment flyers. Participation will be entirely voluntary and based on each individual's free and informed decision.

3. Survey Items
(1) Structured Clinical Interview for Prolonged Grief Disorder (SCIP), Japanese Version
(2) Basic Information
Participant background: age, gender, educational background (highest level attained), marital history, current psychiatric disorders, past psychiatric history, psychiatric medication status, experience with structured psychotherapy
Bereavement background: relationship to the deceased, time since bereavement, type of bereavement, circumstances of death
(3) Self-administered Rating Scales
Prolonged Grief Disorder Scale: PG-13-Revised (PG-13-R), Japanese version
Prolonged Grief Disorder Scale: Inventory of Complicated Grief (ICG), Japanese version
Depression Scale: Patient Health Questionnaire-9 (PHQ-9), Japanese version
Post-Traumatic Stress Disorder Scale: PTSD Checklist for DSM-5 (PCL-5), Japanese version
Generalized Anxiety Disorder Scale: General Anxiety Disorder-7 (GAD-7), Japanese version
Quality of Life Scale: EuroQol-5 Dimensions-5 Level (EQ-5D-5L), Japanese version

Registered date

2026

Year

11

Month

11

Day

Last modified on

2026

Year

11

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066428