UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061019 |
|---|---|
| Receipt number | R000069827 |
| Scientific Title | Long-Term Effects of an Anti-Stigma Educational Intervention During Psychiatric Clinical Clerkship on Medical Students' Stigma: A Single-Center Cluster-Randomized Longitudinal Study |
| Date of disclosure of the study information | 2026/03/23 |
| Last modified on | 2026/03/23 15:13:29 |
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Basic information
Public title
A study of the effects of anti-stigma education during psychiatric clinical clerkship on medical students
Acronym
A study of anti-stigma education during psychiatric clinical clerkship in medical students
Scientific Title
Long-Term Effects of an Anti-Stigma Educational Intervention During Psychiatric Clinical Clerkship on Medical Students' Stigma: A Single-Center Cluster-Randomized Longitudinal Study
Scientific Title:Acronym
Long-term effects of an anti-stigma educational intervention during psychiatric clinical clerkship on stigma among medical students
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine whether an additional anti-stigma educational intervention during psychiatric clinical clerkship affects stigma toward mental illness among fourth- and fifth-year medical students at Kitasato University School of Medicine, and whether these effects are sustained from baseline (T0) to the end of the clerkship (T1) and 6 months after completion of the clerkship (T2). Secondary objectives are to evaluate the effects of the intervention on knowledge about mental illness, stigmatizing attitudes, behavioral intentions, empathy, and help-seeking, as well as the durability of these changes. In addition, the study will explore associations with background factors and qualitatively supplement the findings using free-text responses regarding subjective experiences of the educational content and the reasons for attitudinal changes.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the effectiveness of an educational intervention
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the Japanese version of the Mental Illness: Clinicians' Attitudes Scale version 4 (MICA-4) score from baseline (T0, start of the clerkship) to 6 months after completion of the clerkship (T2)
Key secondary outcomes
1) Change in the Japanese version of the Mental Illness: Clinicians' Attitudes Scale version 4 (MICA-4) score from baseline (T0, start of the clerkship) to the end of the clerkship (T1)
2) Change in the Mental Illness and Disorder Understanding Scale (MIDUS), Jefferson Scale of Empathy Japanese version (JSE-J), Attitudes Toward Seeking Professional Psychological Help Scale-Short Form (ATSPPH-SF), and Reported and Intended Behaviour Scale Japanese version future domain (RIBS-J future) scores from baseline (T0) to 6 months after completion of the clerkship (T2)
3) Change in MIDUS, JSE-J, ATSPPH-SF, and RIBS-J future scores from baseline (T0) to the end of the clerkship (T1)
4) Associations of age, sex, intention to specialize in psychiatry, prior contact with people with mental illness, and previous anti-stigma education with RIBS-J future, MIDUS, MICA-4, JSE-J, and ATSPPH-SF scores at T0, T1, and T2
5) Themes extracted from free-text responses at the end of the clerkship (T1), including memorable experiences and educational content, changes in perceptions and attitudes, and intended future clinical practice
6) Themes extracted from free-text responses 6 months after completion of the clerkship (T2), including remembered educational content, subsequent changes in perceptions and attitudes, and changes in responses in later clinical or daily-life settings
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention group: In addition to usual psychiatric clinical clerkship, participants receive an additional anti-stigma educational intervention on the final day of the clerkship. Usual psychiatric clinical clerkship includes daily interviews and examinations of assigned inpatients, a basic lecture on stigma toward mental illness and small-group discussion using a vignette on the first day of the clerkship (30 minutes), and participation in or observation of psychoeducation/group sessions (90 minutes each, twice). The additional anti-stigma educational intervention is delivered on the final day of the clerkship before the T1 assessment and lasts approximately 30 minutes. It consists of viewing a video in which a person with lived experience of mental illness talks about stigma and recovery (approximately 15 minutes) and a structured reflection exercise on stigma-related experiences during the clerkship, including individual worksheet completion and group sharing (approximately 15 minutes).
Interventions/Control_2
Control group: Participants receive usual psychiatric clinical clerkship alone. Usual psychiatric clinical clerkship includes daily interviews and examinations of assigned inpatients, a basic lecture on stigma toward mental illness and small-group discussion using a vignette on the first day of the clerkship (30 minutes), and participation in or observation of psychoeducation/group sessions (90 minutes each, twice). No additional anti-stigma educational intervention is provided during the study period. For educational fairness, after completion of the 6-month follow-up assessment (T2), participants are provided with the same video material link and reflection worksheet used in the intervention group.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Fourth- or fifth-year medical students at Kitasato University School of Medicine who participate in psychiatric clinical clerkship between March 23, 2026 and March 3, 2028, and who receive an explanation of the study objectives and procedures and provide written informed consent.
Key exclusion criteria
1) Students who have previously completed psychiatric clinical clerkship at Kitasato University School of Medicine.
2) Students with no response to the self-administered questionnaire at baseline (T0).
3) Students who are absent from or discontinue the clerkship for 1 week or longer during the clerkship period.
4) Students who withdraw consent to participate in the study.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Inada |
Organization
Kitasato University School of Medicine
Division name
Department of Psychiatry
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
inadaken@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Inada |
Organization
Kitasato University School of Medicine
Division name
Department of Psychiatry
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
Homepage URL
inadaken@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Ken Inada
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Kitasato University School of Medicine and Hospital Research Ethics Committee
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel
042-778-8273
rinri@med.kitasato-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
北里大学医学部精神科学および北里大学病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 03 | Day |
Date of closure to data entry
| 2028 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2031 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069827
