UMIN-ICDS 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 2023/11/28 14:42:05

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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

Email

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


Email

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

Email

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


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

2023 Year 11 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060392


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name