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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047781
Receipt No. R000054472
Scientific Title Elucidation of biological mechanisms of pathological grief in a longitudinal investigation
Date of disclosure of the study information 2022/05/17
Last modified on 2022/05/17

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Basic information
Public title Understaning of mechanisms in coping with grief after bereavement
Acronym Mechanisms in coping with grief
Scientific Title Elucidation of biological mechanisms of pathological grief in a longitudinal investigation
Scientific Title:Acronym Biological mechanisms of grief
Region
Japan

Condition
Condition Prolonged grief disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Pathological factors
Basic objectives2 Others
Basic objectives -Others Etiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Brain functional and structural imaging measures
Key secondary outcomes Salivary inflammatory markers, salivary oxytocin concentration, oxytocin receptor DNA methylation polymorphism, heart rate variability, physical activity, grief symptoms, depression symptoms, anxiety symptoms, posttraumatic stress symptoms, qality of life, sleep quality, daytime sleepiness, pain empathy, attachment style

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Aged 20 years or older
2) Bereaved of a significant other (a family member, relative, friend, or partner)
3) Bereaved for more than 12 months
4) Capable to provide informed consent
5) MRI indicated
Key exclusion criteria 1) Any psychiatric disorders excluding prolonged grief disorder, depressive disorders, or posttraumatic stress disorder
2) Substance-related disorders within 6 months
3) Self-harm or suicide attempt within 6 months
4) A score less than 24 on Mini-Mental State Examination
5) Neurological disorders
6) Pregnancy

Target sample size 90

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name Yoshiike
Organization National Center of Neurology and Psychiatry
Division name Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code 187-8553
Address 4-1-1 Ogawahigashi, Kodaira, Tokyo
TEL 042-346-2071
Email yoshiike@ncnp.go.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Yoshiike
Organization National Center of Neurology and Psychiatry
Division name Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code 187-8553
Address 4-1-1 Ogawahigashi, Kodaira, Tokyo
TEL 042-346-2071
Homepage URL
Email yoshiike@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 Ethical Committee of National Center of Neuro logy and Psychiatry
Address 4-1-1 Ogawahigashi, Kodaira, Tokyo
Tel 042-346-2071
Email rinri-jimu@ncnp.go.jp

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

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 17 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 Open public recruiting
Date of protocol fixation
2022 Year 03 Month 15 Day
Date of IRB
2022 Year 03 Month 22 Day
Anticipated trial start date
2022 Year 05 Month 10 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2022 Year 05 Month 17 Day
Last modified on
2022 Year 05 Month 17 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054472

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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