UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058273 |
|---|---|
| Receipt number | R000066617 |
| Scientific Title | A controlled trial on the effectiveness of a cognitive-behavioral diversity education program for university students |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/06/25 13:15:59 |
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Basic information
Public title
A controlled trial on the effectiveness of a cognitive-behavioral diversity education program for university students
Acronym
A controlled trial on the effectiveness of a cognitive-behavioral diversity education program for university students
Scientific Title
A controlled trial on the effectiveness of a cognitive-behavioral diversity education program for university students
Scientific Title:Acronym
A controlled trial on the effectiveness of a cognitive-behavioral diversity education program for university students
Region
| Japan |
Condition
Condition
Ability to adapt to diversity
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will conduct a comparative study with an intervention group and a control group to examine the effectiveness of a cognitive-behavioral diversity education program targeted at university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary evaluation indicators
1) We used the Diversity Adaptability Assessment Scale (Tsuki et al., 2015). Measured using 32 items and 7-point scale including "ability to demonstrate individuality," "willingness to take on challenges," "ability to see things from a bird's-eye view," "creativity," "altruism," "tolerance," "ability to build trust," and "communication skills."
Secondary evaluation indicators
2) We used the Diversity Climate Scale for University Students (Oue, 2022). This scale measured 32 items and 5-point scale including "gender education climate: 9 items," "equality education climate: 11 items," "diversity education environment climate: 9 items," and "women's active education climate: 6 items."
3) We used the Irrational Belief Scale (Mori et al., 1994). Measured using 20 items and 5-point scale including "self-expectation," "logical blame," "dependence," "problem avoidance," and "helplessness."
4) We used the Subjective Well-Being Scale (Ito et al., 2003). Measured using 12 items and 4-point scale.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
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
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group participated in a lecture on diversity + a talk on the difficulties minorities face in their student lives (two physically disabled students, two international students, and an LGBTQ person + group work (cognitive restructuring: listening to minorities talk about the difficulties they face in their lives, and clarifying the emotions they feel and their cognition at the time, rather than the difficulties in their lives).
Interventions/Control_2
The control group only received a 60-minute lecture on diversity.
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Undergraduate students enrolled in universities in Japan
Individuals aged 18 years or older who have provided written informed consent to participate in the study
Able to attend all sessions of the cognitive-behavioral diversity education program
No current diagnosis of mental illness and not receiving psychotherapy or psychiatric treatment at the time of the study
Able to read, write, and communicate in Japanese
Key exclusion criteria
Individuals with prior experience in cognitive-behavioral-based education or training
Individuals expected to be unable to participate continuously due to study abroad or prolonged absence during the study period
Individuals who exhibit significant resistance or anxiety toward the content of the cognitive-behavioral diversity education program
Individuals judged to have significant cognitive impairments (e.g., severe intellectual disabilities)
Any other individuals deemed inappropriate for participation by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | OHUE |
| Middle name | |
| Last name | TAKASHI |
Organization
Okayama University
Division name
Graduate School of Health Sciences
Zip code
7008558
Address
Okayama City, Kita Ward, Shikata-cho 2-5-1
TEL
0862356841
t-ohue@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | OHUE |
| Middle name | |
| Last name | TAKASHI |
Organization
Okayama University
Division name
Graduate School of Health Sciences
Zip code
7008558
Address
Okayama City, Kita Ward, Shikata-cho 2-5-1
TEL
0862356841
Homepage URL
t-ohue@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama 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
Hyogo University Ethics Committee
Address
2301 Shinzaike, Hiraoka-cho, Kakogawa City, Hyogo Prefecture
Tel
079-427-5111
ohue@hyogo-dai.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 | 08 | Month | 01 | 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
50
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 | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 01 | 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 | 25 | Day |
Last modified on
| 2025 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066617
