UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061363 |
|---|---|
| Receipt number | R000070208 |
| Scientific Title | A clinical trial of individual psychoeducation to reduce self-stigma of patients with schizophrenia in acute psychiatric wards |
| Date of disclosure of the study information | 2026/04/24 |
| Last modified on | 2026/04/23 16:16:14 |
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Basic information
Public title
A clinical trial of individual psychoeducation to reduce self-stigma of patients with schizophrenia in acute psychiatric wards
Acronym
A clinical trial of individual psychoeducation to reduce self-stigma of patients with schizophrenia in acute psychiatric wards
Scientific Title
A clinical trial of individual psychoeducation to reduce self-stigma of patients with schizophrenia in acute psychiatric wards
Scientific Title:Acronym
A clinical trial of individual psychoeducation to reduce self-stigma of patients with schizophrenia in acute psychiatric wards
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As a preliminary step toward establishing an individual psychoeducation program aimed at reducing self-stigma among patients with schizophrenia in acute psychiatric wards, we will implement the program with a small group of patients to qualitatively and quantitatively evaluate its safety and feasibility regarding self-stigma reduction.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
qualitative data from interviews
Key secondary outcomes
Changes in ISMI, SAI-J, DAI-10, PANSS, and KIDI scores from pre- to post-intervention; completion rates for each questionnaire; session completion rates for the psychoeducation program; and impacts on other symptoms or treatments (e.g., level of participation in occupational therapy, frequency of pro re nata [PRN] medication use).
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
individual 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Diagnosis: Schizophrenia (ICD-10 code: F20.9).
(2)Phase of Illness: Ranging from the rest phase to the recovery phase.
(3)Age: 18 years of age or older.
(4)Sex/Gender: No restrictions.
(5)Setting: Currently hospitalized (Inpatients).
(6)Informed Consent: Patients who have provided written informed consent to participate in the study.
(7)Clinical Suitability: Patients judged by their attending physician to be capable of continuous participation in psychoeducation.
(8)Comorbidities: No comorbid psychiatric disorders other than schizophrenia.
(9)Communication: Patients capable of smooth/effective communication.
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hatsumi |
| Middle name | |
| Last name | Yoshii |
Organization
Tohoku University School of medicine
Division name
Psychiatric Nursing
Zip code
980-8575
Address
Bldg. B, School of Health Sciences, Tohoku University School of Medicine, 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
022-717-7954
hatsumi.yoshii.d8@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Toshi |
Organization
Tohoku University School of medicine
Division name
Psychiatric Nursing
Zip code
980-8575
Address
Bldg. B, School of Health Sciences, Tohoku University School of Medicine, 2-1 Seiryo-machi, Aoba-ku
TEL
080-3327-2415
Homepage URL
keita.toshi.t2@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Keita Toshi
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
Tohoku University
Address
Bldg. B, School of Health Sciences, Tohoku University School of Medicine, 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
Tel
080-3327-2415
keita.toshi.t2@dc.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
菅野愛生会緑ヶ丘病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 24 | 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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2031 | Year | 03 | 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
| 2026 | Year | 04 | Month | 23 | Day |
Last modified on
| 2026 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070208
