UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058204 |
|---|---|
| Receipt number | R000065778 |
| Scientific Title | Development of a training program to support sexuality for people with mental illness |
| Date of disclosure of the study information | 2025/06/18 |
| Last modified on | 2025/06/23 09:33:42 |
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Basic information
Public title
Development of a training program to support sexuality for people with mental illness
Acronym
Development of a training program to support sexuality for people with mental illness
Scientific Title
Development of a training program to support sexuality for people with mental illness
Scientific Title:Acronym
Development of a training program to support sexuality for people with mental illness
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this project is to develop a training program to enable mental health professionals to appropriately support the sexuality of people with mental illness living in the community and to evaluate its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Inadequate Qualification Scale for Sex Education Practice
Key secondary outcomes
Attitudes towards sexuality scale, knowledge about sex education, knowledge about preconception care for people with mental illness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
This is an online training on sexuality support, conducted in small groups of up to 8 participants and facilitators combined, for a total of approximately 4 hours. It uses a combination of a sex education text compliant with the International Sexuality Guidance and an original text created on sexuality support for people with mental illness. Participants will gain knowledge from the text and exchange opinions on support cases.
Interventions/Control_2
No intervention
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
Professionals (qualified) over 18 years old who support people with mental illness in the community
Key exclusion criteria
People who cannot participate via web survey or ZOOM
People who have difficulty discussing in Japanese in a group
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Kageyama |
Organization
The University of Osaka
Division name
Institute of Advanced Co-Creation Studies, The University of Osaka / Division of Health Sciences, Graduate School of Medicine, The University of Osaka
Zip code
565-0871
Address
Yamadaoka 1-7, Suita, Osaka, Japan
TEL
0668792553
kageyama@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Kageyama |
Organization
The University of Osaka
Division name
Institute of Advanced Co-Creation Studies, The University of Osaka / Division of Health Sciences,
Zip code
565-0871
Address
Yamadaoka 1-7, Suita, Osaka, Japan
TEL
0668792553
Homepage URL
https://kageyamaresearch.wixsite.com/srhr
kageyama@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Masako Kageyama
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board Osaka University Hospital
Address
Yamadaoka 2-2. Suita, Osaka, Japan
Tel
06-6210-8290
rinri@hp-crc.med.osaka-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 18 | 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
| 2025 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2025 | Year | 06 | Month | 17 | Day |
Last modified on
| 2025 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065778
