UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062452 |
|---|---|
| Receipt number | R000071087 |
| Scientific Title | Intervention Study Using a Self-Compassion App for Nurses at Our Hospital |
| Date of disclosure of the study information | 2026/08/03 |
| Last modified on | 2026/08/03 17:00:39 |
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Basic information
Public title
Intervention Study Using a Self-Compassion App for Nurses at Our Hospital
Acronym
Intervention Study Using a Self-Compassion App
Scientific Title
Intervention Study Using a Self-Compassion App for Nurses at Our Hospital
Scientific Title:Acronym
Intervention Study Using a Self-Compassion App
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate whether the use of a self-compassion app improves the mental health of nurses at our hospital. We will investigate the efficacy and safety of the self-compassion app intervention program. For the nurses at our hospital, who face various forms of mental and physical stress amidst their busy schedules, it is considered important to use smartphone applications to easily evaluate the utility of mental health treatments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese Version of the Burnout Assessment Tool (BAT-J)
Key secondary outcomes
PHQ-9 (Patient Health Questionnaire-9)
GAD-7 (Generalized Anxiety Disorder-7)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
We will have nurses at our hospital use Awarefy, a mental health self-care app, and conduct psychological assessments before and after its use.
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The study targets nurses working at Juntendo Hospital or the Juntendo University Hongo/Ochanomizu Campus between the date research implementation is approved and September 30, 2027.
1. Adults aged 18 to under 60
2. Individuals who understand the use of mobile applications
3. Individuals who have received a thorough explanation regarding participation in this study and have provided written consent of their own free will, based on a full understanding of the study
Key exclusion criteria
1. Individuals for whom use of the app could have an adverse effect on their health (e.g., severe epilepsy)
2. Individuals with physical limitations (e.g., severe visual or hearing impairments)
3. Individuals deemed unsuitable by the principal investigator based on factors such as current medical history, treatment history, or diagnosis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Narimasa |
| Middle name | |
| Last name | Katsuta |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Psychiatry
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
nkatsuta@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Narimasa |
| Middle name | |
| Last name | Katsuta |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Psychiatry
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
nkatsuta@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Awarefy Inc., Awarefy Mental Research Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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
| 2026 | Year | 08 | Month | 03 | 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 | 07 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 31 | 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 | 08 | Month | 03 | Day |
Last modified on
| 2026 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071087
