UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050466 |
|---|---|
| Receipt number | R000057483 |
| Scientific Title | A Study on Self-Efficacy Enhancement of Ground Self-Defense Force Personnel -Support based on the theory of cognitive-behavioral therapy |
| Date of disclosure of the study information | 2023/03/02 |
| Last modified on | 2025/01/15 20:50:46 |
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Basic information
Public title
A Study on Self-Efficacy Enhancement of Ground Self-Defense Force Personnel
-Support based on the theory of cognitive-behavioral therapy
Acronym
A Study on Self-Efficacy Enhancement of Ground Self-Defense Force Personnel
Scientific Title
A Study on Self-Efficacy Enhancement of Ground Self-Defense Force Personnel
-Support based on the theory of cognitive-behavioral therapy
Scientific Title:Acronym
A Study on Self-Efficacy Enhancement of Ground Self-Defense Force Personnel
Region
| Japan |
Condition
Condition
nothing
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine, using qualitative and quantitative methods, whether support based on cognitive-behavioral therapy theory is effective in improving the self-efficacy of GSDF personnel.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree to which mental discomfort makes the study intolerable.For example, during the interview survey, the patient recalls unpleasant experiences in the past, resulting in palpitations and emotional incontinence, etc.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Two hundred and fifty GSDF members will take a total of three questionnaires: the Self-Efficacy Scale, the Resilience Test, and the Beck Depression Test.
Interventions/Control_2
50 of the 250 GSDF members will attend the psycho-education program.
Interventions/Control_3
Conduct interviews with several of the participants in the psycho-education program.
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Ground Self-Defense Forces personnel
Key exclusion criteria
Persons who cannot tolerate this research
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Fujimaru |
| Middle name | |
| Last name | Takahiro |
Organization
Asahikawa Medical University
Division name
Psychology Class
Zip code
078-8510
Address
1-1-1, Midorigaoka Higashi 2-jo, Asahikawa-shi, Hokkaido
TEL
08060978127
excellentkeeperf@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Fujimaru |
Organization
Asahikawa Medical University
Division name
Psychology Class
Zip code
078-8510
Address
1-1-1, Midorigaoka Higashi 2-jo, Asahikawa-shi, Hokkaido
TEL
08060978127
Homepage URL
excellentkeeperf@yahoo.co.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical 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
Asahikawa Medical University
Address
1-1-1, Midorigaoka Higashi 2-jo, Asahikawa-shi, Hokkaido
Tel
0166652111
excellentkeeperf@yahoo.co.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 | 03 | Month | 02 | 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
In the first stage, 108 people were asked to complete three questionnaires each for the GSES, BDI, and SHR.
In the second stage, cognitive behavioral therapy was implemented for 10 people in individual interviews and three groups (10 people per group) in group interviews.
Before and after cognitive behavioral therapy, people were asked to complete three questionnaires each for the GSES, BDI, and SHR. We are currently working on compiling the changes in the values.
Results date posted
| 2025 | Year | 01 | Month | 15 | Day |
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 03 | Month | 01 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057483
