UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057923 |
|---|---|
| Receipt number | R000066212 |
| Scientific Title | A Study on Mental Health among Bereaved Individuals |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/20 17:19:46 |
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Basic information
Public title
Examining the Effects of Remembering the Deceased on Mental Health in Bereaved Individuals
Acronym
Study on Mental Health of Bereaved Individuals
Scientific Title
A Study on Mental Health among Bereaved Individuals
Scientific Title:Acronym
A Study on Mental Health among Bereaved Individuals
Region
| Japan |
Condition
Condition
Psychological Stress and Grief Reactions Associated with Bereavement
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of remembering the deceased (conversation and physical contact) on mental health indicators following bereavement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
K6 score
Key secondary outcomes
PANAS (affective state) scores, Changes in Brief Grief Questionnaire (BGQ), Single-item ICG, Meaning and Benefit Finding Scale, and Belongingness Reduction Scale.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Control group: No task to recall the deceased
Interventions/Control_2
Auditory recall group: Remembering conversation with the deceased
Interventions/Control_3
Tactile recall group: Remembering physical contact with the deceased
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults who lost a partner or child within the past year
Key exclusion criteria
None
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yotaro |
| Middle name | |
| Last name | Katsumata |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Humanities
Zip code
192-0397
Address
1-1 Minami-Osawa, Hachioji-shi, Tokyo, Japan
TEL
042-677-1111
yotaro-k@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Igarashi |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Humanities
Zip code
192-0397
Address
1-1 Minami-Osawa, Hachioji-shi, Tokyo, Japan
TEL
042-677-1111
Homepage URL
iga_y@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University, Minami-Osawa Campus Guidelines for Research Ethics
Address
1-1 Minami-Osawa, Hachioji-shi, Tokyo, Japan
Tel
N/A
N/A
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
オンライン調査（全国）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 20 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066212
