UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061482 |
|---|---|
| Receipt number | R000070353 |
| Scientific Title | Effect of a self-COMPAssion focused online psyChoTherapy for people with bereavement related grief: the COMPACT randomized controlled study |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/05/07 20:38:08 |
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Basic information
Public title
Effect of a self-COMPAssion focused online psyChoTherapy for people with bereavement related grief: the COMPACT randomized controlled study
Acronym
Effect of a self-COMPAssion focused online psyChoTherapy for people with bereavement related grief: the COMPACT randomized controlled study
Scientific Title
Effect of a self-COMPAssion focused online psyChoTherapy for people with bereavement related grief: the COMPACT randomized controlled study
Scientific Title:Acronym
Effect of a self-COMPAssion focused online psyChoTherapy for people with bereavement related grief: the COMPACT randomized controlled study
Region
| Japan |
Condition
Condition
Individuals aged 18 or older who have experienced bereavement more than six months ago and are experiencing grief related to bereavement.
Classification by specialty
| Medicine in general | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of online group psychotherapy focused on self-compassion for individuals experiencing bereavement grief, using grief scores as the primary outcome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Inventory Complicated Grief (Japanese version, 19 questions): Score at 12 weeks.
Key secondary outcomes
Inventory Complicated Grief (Japanese version, 19 questions)
Prolonged Grief Disorder Assessment Scale (PG-13, Japanese version)
PHQ-9
GAD-7
Self-Compassion Scale (26-question version)
Brief Resilience Scale (6 questions)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Online group psychotherapy focused on self-compassion
Interventions/Control_2
Wait list control
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Applicants must meet all of the following criteria:
* Be 18 years of age or older, have experienced bereavement at least six months ago, and are experiencing grief related to bereavement.
* Regularly use a smartphone (iPhone, Android, etc.) or computer with a stable internet connection, or be able to use a smartphone or computer with a stable internet connection with the support of family or friends.
* Be able to participate in the program and answer questionnaires in Japanese.
Key exclusion criteria
The following individuals will be excluded:
* Individuals currently receiving psychiatric treatment (unless authorized by a psychiatrist to participate in this study).
* Individuals deemed unsuitable for participation by researchers due to physical, mental, or cognitive problems, or difficulties with operating electronic devices.
Target sample size
182
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Uneno |
Organization
Kobe University Hospital
Division name
Department of Palliative and Supportive Care
Zip code
650-0017
Address
5-2 7 chome Kusunokicho Chuo-ku Kobe City
TEL
078-382-6531
uneno@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Uneno |
Organization
Kobe University Hospital
Division name
Department of Palliative and Supportive Care
Zip code
650-0017
Address
5-2 7 chome Kusunokicho Chuo-ku Kobe City
TEL
078-382-6531
Homepage URL
https://compact-trial.com/
uneno@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Yu Uneno
Funding Source
Organization
Japanese Society for Palliative Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital
Address
5-2 7 chome Kusunokicho Chuo-ku Kobe City
Tel
078-382-6531
uneno@med.kobe-u.ac.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
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | 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
| 2026 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | 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
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070353
