UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063312 |
|---|---|
| Receipt number | R000072379 |
| Scientific Title | Examining the Mechanisms of Resilience Enhancement Through a Solution-Focused Intervention: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/10/16 |
| Last modified on | 2026/10/16 13:02:09 |
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Basic information
Public title
Examining the Mechanisms of Resilience Enhancement Through a Solution-Focused Intervention: A Randomized Controlled Trial
Acronym
Examining the Mechanisms of Resilience Enhancement Through a Solution-Focused Intervention: A Randomized Controlled Trial
Scientific Title
Examining the Mechanisms of Resilience Enhancement Through a Solution-Focused Intervention: A Randomized Controlled Trial
Scientific Title:Acronym
Examining the Mechanisms of Resilience Enhancement Through a Solution-Focused Intervention: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Stress-related diseases
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the Effects of Implementing a Solution-Focused Approach on Perceived Control and Resilience
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
resilience (Bidimensional Resilience Scale; Measurements were taken before the intervention (Time 1), immediately after the intervention (Time 2), and approximately two weeks later (Time 3).)
Key secondary outcomes
Perceived Control, Difficulty of Problem, Causal Attribution(Measurements were taken before the intervention (Time 1), immediately after the intervention (Time 2), and approximately two weeks later (Time 3).)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Recall one problem that has a persistent negative impact on your daily life, and freely describe how you envision resolving it in the following three time periods: "from when you wake up until noon," "from noon until evening," and "from evening until bedtime."
To achieve the desired solution, freely describe your behavioral goals for the following three time periods: "from waking up until noon," "from noon until evening," and "from evening until bedtime."
Write a free-form description of a situation in which the goal was achieved, even if only partially.
Interventions/Control_2
Recall one issue that has a persistent negative impact on your daily life, and freely write down your thoughts about it.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 20 to 59 who are Japanese
Key exclusion criteria
1. People under the age of 20 or 60 or older
2. People currently receiving treatment at a psychiatric or psychosomatic medicine clinic
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Fumiaki |
| Middle name | |
| Last name | Nitta |
Organization
Shibata Gakuen University
Division name
Department of Child Development, Faculty of Human Life Design
Zip code
036-8530
Address
1-1-16 Kiyohara, Hirosaki-shi, Aomori, Japan
TEL
0172-33-2289
f-nitta@shibata-univ.net
Public contact
Name of contact person
| 1st name | Fumiaki |
| Middle name | |
| Last name | Nitta |
Organization
Shibata Gakuen University
Division name
Department of Child Development, Faculty of Human Life Design
Zip code
036-8530
Address
1-1-16 Kiyohara, Hirosaki-shi, Aomori, Japan
TEL
0172-33-2289
Homepage URL
f-nitta@shibata-univ.net
Sponsor or person
Institute
Shibata Gakuen University
Institute
Department
Personal name
Fumiaki Nitta
Funding Source
Organization
Shibata Gakuen University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shibata Gakuen University Committee on Research Ethics Involving Human Subjects
Address
1-1-16 Kiyohara, Hirosaki-shi, Aomori, Japan
Tel
0172-33-2289
f-nitta@shibata-univ.net
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 | 10 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
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
| 2025 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 30 | 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 | 10 | Month | 16 | Day |
Last modified on
| 2026 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072379
