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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041743
Receipt No. R000045041
Scientific Title Development and evaluation of a peer-led learning program about romantic relationships and marriage of persons with mental disorders
Date of disclosure of the study information 2020/09/09
Last modified on 2020/09/09

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Basic information
Public title Development and evaluation of a peer-led learning program about romantic relationships and marriage of persons with mental disorders
Acronym Peer-led learning program about romantic relationships and marriage
Scientific Title Development and evaluation of a peer-led learning program about romantic relationships and marriage of persons with mental disorders
Scientific Title:Acronym Peer-led learning program about romantic relationships and marriage
Region
Japan

Condition
Condition mental disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this intervention is to develop a peer-learning program on the theme of romantic relationships and marriage for people with mental disorders and evaluate its effectiveness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recovery Assessment Scale
Key secondary outcomes Self-esteem scale, Hope Herth Index, etc

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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
Behavior,custom
Interventions/Control_1 The intervention period is 2 days
For the intervention group, perform a questionnaire-based outcome evaluation before, immediately after, and one month later.
In the intervention group, conduct an interview survey one month later after answering the questionnaire and evaluate the intervention process.
1 group 2-3 facilitators, up to 10 people in total including participants
I carry out 60 minutes five times once in two days
Use text (A5 size, about 60 pages)
Interventions/Control_2 In the control group, conduct a questionnaire survey at three points at the same timing as the intervention group without intervention. After completing the questionnaire survey at three-time points, ethical considerations will provide the applicant with a program similar to 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Adults (aged 20 and over) who meet all of the following
1. Outpatient receiving a diagnosis of mental illness
2. It is judged that the mental symptoms are stable enough to allow the attending psychiatrist to participate in this study
3. The psychiatrist of mental illness judges that participation in this study is not expected to hinder psychiatric treatment
4. Communicate well, understand research explanations well, and judge research cooperation by themselves
5. Participate in group discussions using Japanese without difficulty
Key exclusion criteria Persons with disabilities other than mental disorders (development, intellectual, physical disabilities)
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Masako
Middle name
Last name Kageyama
Organization Osaka University Graduate School of Medicine
Division name Division of Health Sciences
Zip code 565-0871
Address Yamadaoka 1-7, Suita, Osaka
TEL 06-6879-2553
Email kageyama@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Masako
Middle name
Last name Kageyama
Organization Osaka University Graduate School of Medicine
Division name Division of Health Sciences
Zip code 565-0871
Address Yamadaoka 1-7, Suita, Osaka
TEL 06-6879-2553
Homepage URL
Email kageyama@sahs.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization KAKENHI
Organization
Division
Category of Funding Organization Other
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, 565-0871
Tel 06-6210-8289
Email 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 横浜など

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 09 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 09 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2025 Year 12 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
2020 Year 09 Month 09 Day
Last modified on
2020 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045041

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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