UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057340 |
|---|---|
| Receipt number | R000062115 |
| Scientific Title | Impact of a group-based compassion-focused approach for socially isolated people |
| Date of disclosure of the study information | 2025/03/20 |
| Last modified on | 2025/03/19 16:09:34 |
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Basic information
Public title
Impact of a group-based compassion-focused approach for socially isolated people
Acronym
Impact of a group-based compassion-focused approach for socially isolated people
Scientific Title
Impact of a group-based compassion-focused approach for socially isolated people
Scientific Title:Acronym
compassion-focused approach for socially isolated people
Region
| Japan |
Condition
Condition
Social isolation such as hikikomori or non-attendance at school
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to examine the impact of a group-based, compassion-focused approach for socially isolated people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Self-compassion
Key secondary outcomes
Loneliness
State-Trait Anxiety
Satisfaction with the intervention
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention is based on the principles of Compassion Focused Therapy and comprises 12 sessions.
Interventions/Control_2
Control group/ None
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
- Persons aged 18 and over who have experienced social isolation such as hikikomori or non-attendance at school and are currently in a period of recovery.
- Family members of those who have experienced social isolation.
Key exclusion criteria
inability to speak Japanese well enough to participate in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Funakoshi |
Organization
Kobe City College of Nursing
Division name
Nursing
Zip code
651-2103
Address
3-4 Gakuennishi-machi, Nishi-ku, Kobe
TEL
078-794-8080
funakoshi@kobe-ccn.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Funakoshi |
Organization
Kobe City College of Nursing
Division name
Nursing
Zip code
651-2103
Address
3-4 Gakuennishi-machi, Nishi-ku, Kobe
TEL
078-794-8080
Homepage URL
funakoshi@kobe-ccn.ac.jp
Sponsor or person
Institute
Kobe City College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee of Kobe City College of Nursing
Address
3-4 Gakuennishi-machi, Nishi-ku, Kobe
Tel
078-794-8080
rinri@kobe-ccn.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 20 | 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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | 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 | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062115
