UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055387 |
|---|---|
| Receipt number | R000063293 |
| Scientific Title | Effectiveness of Stress Management Interventions Using Behavior Change Techniques Among University Students |
| Date of disclosure of the study information | 2024/08/31 |
| Last modified on | 2025/07/17 11:56:42 |
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Basic information
Public title
Effectiveness of Stress Management Interventions Using Behavior Change Techniques Among University Students
Acronym
Effectiveness of Stress Management Interventions Using Behavior Change Techniques Among University Students
Scientific Title
Effectiveness of Stress Management Interventions Using Behavior Change Techniques Among University Students
Scientific Title:Acronym
Effectiveness of Stress Management Interventions Using Behavior Change Techniques Among University Students
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether the introduction of behavior change techniques into standard breathing-based stress management can facilitate the integration and habituation of stress management practices into daily life, and whether it can further reduce stress responses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PsychologicalStressResponseScale (SRS-18; Suzuki et al., 1997) https://www.jstage.jst.go.jp/article/jjbm/4/1/4_22/_article/-char/ja/
Time 1 (Baseline), Time 2 (Immediately after watching the intervention video), Time 3 (One month after the start of the behavior change intervention), Time 4 (Follow-up one month after the end of the behavior change intervention)
Key secondary outcomes
1) Japaneseversion ef Positiveand NegativeAffectSchodule (PANAS: Sato & Yasuda, 2001) https://www.jstage.jst.go.jp/article/jjpjspp/9/2/9_KJ00001287160/_pdf
2) Short-form self-report measure to assess relaxation effects (S-MARE: Sakakibara et al., 2014) https://www.jstage.jst.go.jp/article/jjpsy/85/3/85_85.13210/_pdf/-char/ja
3) Self-efficacy for Practicing Breathing Techniques
4) Impressions of the Intervention Video
5) Subjective Sense of Relaxation
6) Impressions of the Behavior Change (Answered by the intervention group only)
Time 1 (Baseline), Time 2 (Immediately after watching the intervention video), Time 3 (One month after the start of the behavior change intervention), Time 4 (Follow-up one month after the end of the behavior change intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention Group 1 (Group with Behavior Change): After the Time 1 assessment, participants watch the intervention video and perform the breathing exercises as instructed in the video. The Time 2 assessment is conducted immediately after watching the video, followed by a one-month behavior change intervention. One month after the Time 2 assessment, the behavior change intervention concludes, and the Time 3 assessment is conducted. One month after the Time 3 assessment, the Time 4 assessment (follow-up) is conducted.
Interventions/Control_2
Intervention Group 2 (Group without Behavior Change): After the Time 1 assessment, participants watch the intervention video and perform the breathing exercises as instructed in the video. The Time 2 assessment is conducted immediately after watching the video, and the Time 3 assessment is conducted one month later. One month after the Time 3 assessment, the Time 4 assessment is conducted.
Interventions/Control_3
Control Group (Waiting-list Group): After the Time 1 assessment, participants are presented with a news article that can be read in approximately five minutes. The article's content is related to breathing techniques or diaphragmatic breathing and is selected from Asahi Shimbun Cross-Search, consisting of around 1,500 characters. The Time 2 assessment is conducted after presenting the article, and the Time 3 assessment is conducted one month later. One month after the Time 3 assessment, the Time 4 assessment is conducted. Additionally, after the completion of the Time 4 assessment, the waiting-list group begins the intervention with the behavior change group. The intervention schedule for the waiting-list group is determined individually based on the preferences of the research participants after the Time 4 assessment.
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
Inclusion criteria for this study are: university students aged 18 years or older enrolled at Chuo University, who are in good health and are capable of operating a smartphone or PC on a daily basis.
Key exclusion criteria
Exclusion criteria for this study include: individuals currently undergoing treatment for any mental or cardiovascular disorders, those who have been advised against participation by a physician, and those who are unable to operate a smartphone or PC on a daily basis.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nanako |
| Middle name | |
| Last name | Nakamura-Taira |
Organization
Chuo University
Division name
Faculty of Letters
Zip code
192-0393
Address
742-1 Higashinakano Hachioji-shi, Tokyo
TEL
042-674-3844
nanako@tamcc.chuo-u.ac.jp
Public contact
Name of contact person
| 1st name | Nanako |
| Middle name | |
| Last name | Nakamura-Taira |
Organization
Chuo University
Division name
Faculty of Letters
Zip code
192-0393
Address
742-1 Higashinakano Hachioji-shi, Tokyo
TEL
042-674-3844
Homepage URL
nanako@tamacc.chuo-u.ac.jp
Sponsor or person
Institute
Chuo University
Institute
Department
Personal name
Nanako Nakamura-Taira
Funding Source
Organization
Chuo Universiy
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
Chuo University Research Ethics Committee
Address
Kasuga 1-13-27, Bunkyo-ku, Tokyo
Tel
03-3817-7433
hitorinri-grp@g.chuo-u.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
中央大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 31 | 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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 31 | Day |
Last modified on
| 2025 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063293
