UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058224 |
|---|---|
| Receipt number | R000066563 |
| Scientific Title | Randomized Controlled Trial on Affect Improvement Using an App-Based Stress Management Intervention |
| Date of disclosure of the study information | 2025/06/20 |
| Last modified on | 2025/06/19 17:03:45 |
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Basic information
Public title
Effect of an App-Based Stress Management Intervention on Affect in University Students: A Randomized Controlled Trial
Acronym
Affect Improvement by App-Based Stress Management
Scientific Title
Randomized Controlled Trial on Affect Improvement Using an App-Based Stress Management Intervention
Scientific Title:Acronym
Affect Improvement by App-Based Stress Management
Region
| Japan |
Condition
Condition
Mental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the effects of an app-based stress management intervention on affect (positive affect score, negative affect score, and positive affect balance) among university students at Kanazawa Institute of Technology. This study was retrospectively registered after study initiation, due to an initial lack of full awareness regarding the need for trial registration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in affect (positive affect score, negative affect score, and positive affect balance) will be assessed at three time points: pre-intervention, post-intervention, and follow-up (approximately three weeks after intervention). The Positive and Negative Affect Schedule (PANAS) will be used as the assessment tool.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
| Other |
Interventions/Control_1
Participants in the intervention group used the app over a period of three weeks to select and implement stress management behaviors such as music, relaxation, or breathing exercises.
Interventions/Control_2
Participants in the wait-list control group did not receive the intervention during the study period, but were provided access to the app after the follow-up assessment.
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
Students in Kanazawa Institute of Technology
Key exclusion criteria
We excluded the students who cannot understand Japanese.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Fusejima |
Organization
Kanazawa Institute of Technology
Division name
Department of Psychological Informatics and Design, College of Media and Informatics
Zip code
921-8501
Address
7-1 Ohgigaoka, Nonoichi, Ishikawa 921 8501, Japan
TEL
076-248-1100
fusejima@neptune.kanazawa-it.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Fusejima |
Organization
Kanazawa Institute of Technology
Division name
Department of Psychological Informatics and Design, College of Media and Informatics
Zip code
921-8501
Address
7-1 Ohgigaoka, Nonoichi, Ishikawa 921 8501, Japan
TEL
076-248-1100
Homepage URL
fusejima@neptune.kanazawa-it.ac.jp
Sponsor or person
Institute
Kanazawa Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
GOCCO Corporation.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Subjects Research Ethics Review Committee at Kanazawa Institute of Technology
Address
7-1 Ohgigaoka, Nonoichi, Ishikawa 921-8501, Japan
Tel
076-248-1100
rinri-j at mlist.kanazawa-it.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 | 06 | Month | 20 | Day |
Related information
URL releasing protocol
https://osf.io/qz9fh
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.11560/jahpp.36.0_106
Number of participants that the trial has enrolled
65
Results
The participants were randomly assigned to either the intervention group or the waiting list group. The analysis in the ITT analysis included 28 participants in the intervention group and 26 participants in the waiting list group. The application-based intervention was found to reduce negative affect and improve positive affect balance.
Results date posted
| 2025 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 02 | Day |
Baseline Characteristics
Intervention group
age (SD): 19.5(1.8)
sex:M/F: 11/17
Wait-list group
age(SD): 19.3 (1.8)
sex:M/F: 12/14
Participant flow
We invited students to participate in classes at the Kanazawa Institute of Technology.　After informed consent was obtained in writing, participants were invited to participate in the study.
Adverse events
none
Outcome measures
Log data (screen time, content and evaluation of content)
Questionnaire: PANAS
Impression of application use
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 16 | 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 | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066563
