UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051597 |
|---|---|
| Receipt number | R000058412 |
| Scientific Title | Verification of the Effectiveness of Mental Health Support Program Using Self-Compassion for Local Residents |
| Date of disclosure of the study information | 2023/07/12 |
| Last modified on | 2023/07/12 21:16:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Verification of the Effectiveness of Mental Health Support Program Using Self-Compassion for Local Residents
Acronym
Verification of the Effectiveness of Mental Health Support Program Using Self-Compassion for Local Residents
Scientific Title
Verification of the Effectiveness of Mental Health Support Program Using Self-Compassion for Local Residents
Scientific Title:Acronym
Verification of the Effectiveness of Mental Health Support Program Using Self-Compassion for Local Residents
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to implement a mental health support program with self-compassion for people living in the community and to clarify the effectiveness of the program.
Basic objectives2
Others
Basic objectives -Others
The mental health support program with self-compassion will be implemented for people living in the community, and its effectiveness will be clarified using the K6 and the Mental Resilience Scale as secondary evaluation items.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
self-compassion
Key secondary outcomes
K6, Resilience
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Implement mental health support programs that focus on self-compassion.
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
| 66 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A. Local residents aged 20-65, male and female.
B. Must be able to attend all four sessions of the program.
C. Never attended an outpatient psychiatric clinic and have a cutoff point of less than 15 on the K6 (Anxiety and Depression Scale) in the selection criteria check.
Key exclusion criteria
Even if a subject meets the selection criteria, he/she will be excluded if he/she declines to participate in the study. Even if the cutoff point is less than 15 in K6, this is only a guideline, and those who are judged to be unsuitable by the researcher will be excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasuko |
| Middle name | |
| Last name | Koyano |
Organization
The Jikei University
Division name
School of Nursing/ Graduate School of Medicine
Zip code
182-8570
Address
8-3-1 kokuryo, Cyofu, Tokyo
TEL
+81-3-480-1151
ykoyano@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Koyano |
Organization
The Jikei University
Division name
School of Nursing/ Graduate School of Medicine
Zip code
182-8570
Address
8-3-1 kokuryo, Cyofu, Tokyo
TEL
+81-3-480-1151
Homepage URL
ykoyano@jikei.ac.jp
Sponsor or person
Institute
The Jikei University
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University
Address
3-25-8,nishisinbasi ,Minato-ku,Tokyo
Tel
03(3433)1111/+81-3-3433-1111
ykoyano@jikei.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
| 2023 | Year | 07 | Month | 12 | 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
| 2022 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2023 | Year | 07 | Month | 12 | Day |
Last modified on
| 2023 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058412
