UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052932 |
|---|---|
| Receipt number | R000060392 |
| Scientific Title | Implementing a psychoeducation program to reduce self-stigma for patients with schizophrenia at a psychiatric acute ward in Japan: a pilot study for healthy subjects |
| Date of disclosure of the study information | 2023/11/28 |
| Last modified on | 2024/05/29 14:56:40 |
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Basic information
Public title
Implementing a psychoeducation program to reduce self-stigma for patients with schizophrenia at a psychiatric acute ward in Japan: a pilot study for healthy subjects
Acronym
Implementing a psychoeducation program to reduce self-stigma for patients with schizophrenia at a psychiatric acute ward in Japan: a pilot study for healthy subjects
Scientific Title
Implementing a psychoeducation program to reduce self-stigma for patients with schizophrenia at a psychiatric acute ward in Japan: a pilot study for healthy subjects
Scientific Title:Acronym
Implementing a psychoeducation program to reduce self-stigma for patients with schizophrenia at a psychiatric acute ward in Japan: a pilot study for healthy subjects
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to examine the safety and feasibility of a psychoeducation program, and modify the content of the program and survey by doing a pilot study to nurses who work at a psychiatric acute ward in Japan.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
qualitative interview
Key secondary outcomes
the response time and answer completion rate of questionnaire surveys: SAI-J, DAI-10, PANSS, KIDI
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
psychoeducation
Interventions/Control_2
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
1. registered nurse or licensed vocational nurse
2. a regular staff working at the hospital
3. regardless of age
4. regardless of gender
5. no history of psychiatric treatment
6. those who consented to participate in the study
Key exclusion criteria
none
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hatsumi |
| Middle name | |
| Last name | Yoshii |
Organization
Tohoku University Graduate School of Medicine
Division name
Psychiatric Nursing
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7954
hatsumi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Toshi |
Organization
Tohoku University Graduate School of Medicine
Division name
Psychiatric Nursing
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7916
Homepage URL
keita.toshi.t2@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku 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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
医療法人菅野愛生会緑ヶ丘病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 28 | 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
| 2023 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2028 | Year | 10 | 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
| 2023 | Year | 11 | Month | 28 | Day |
Last modified on
| 2024 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060392
