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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035131
Receipt No. R000040043
Official scientific title of the study Prospective observational study on factors associated with personal recovery for inpatients with psychotic disorders
Date of disclosure of the study information 2019/01/07
Last modified on 2018/12/04

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Basic information
Official scientific title of the study Prospective observational study on factors associated with personal recovery for inpatients with psychotic disorders
Title of the study (Brief title) Prospective observational study on factors associated with personal recovery for inpatients with psychotic disorders
Region
Japan

Condition
Condition psychotic disorders
Classification by specialty
Psychiatry Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To measure the change of indices of personal recovery among inpatients with psychotic disorders using four scales as main outcomes and to investigate relating factors with those.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recovery Assessment Scale 24 (RAS)
Self-Identified stage of recovery Part-A(SISR-A)
Self-Identified stage of recovery Part-B (SISR-B)
Questionnaire about the Process of Recovery(QPR-J
Key secondary outcomes Recovery Assessment Scale 24 (RAS)
Self-Identified stage of recovery Part-A(SISR-A)
Self-Identified stage of recovery Part-B (SISR-B)
Questionnaire about the Process of Recovery(QPR-J)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
16 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Patients with schizophrenia spectrum and other psychotic disorders such as delusional disorder, brief psychotic disorder, schizophreniform disorder, schizophrenia, or schizoaffective disorder including those in remission of psychotic episode diagnosed using DSM-5 who are hospitalized in psychiatric wards at recruitment in the study.
Key exclusion criteria Those who (1) have severe physical symptoms precluding the participation to the research, (2) are not able to comprehend speech in Japanese, (3) have psychotic disorders induced by substance use or medication, (4)with neurocognitive disorders, (5) are judged by doctors in charge not to have the sufficient ability to judge the matters, (6) are under compulsory admission by the power of local government"Sochi-nyuin"(7) are isolated or physically bound at the bed, or (8) are going to transfer to other hospitals
Target sample size 40

Research contact person
Name of lead principal investigator Norika Mitsunaga
Organization Tohoku University Graduate School of Medicine
Division name Department of Psychiatric Nursing
Address 2-1,Seiryo-machi, Aoba-Ku, Sendai, 980-8575, Japan
TEL 022-717-7916
Email mitsuanga@med.tohoku.ac.jp

Public contact
Name of contact person Norika Mitsunaga
Organization Tohoku University Graduate School of Medicine
Division name Department of Psychiatric Nursing
Address 2-1,Seiryo-machi, Aoba-Ku, Sendai, 980-8575, Japan
TEL 022-717-7916
Homepage URL
Email mitsuanga@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2019 Year 01 Month 07 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 01 Day
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information To measure the change of indices of personal recovery among inpatients with psychotic disorders using four scales as main outcomes and to investigate relating factors with those. Primari outcomes are Recovery Assessment Scale 24 (RAS), Self-Identified stage of recovery Part-A(SISR-A), Self-Identified stage of recovery Part-B (SISR-B), Questionnaire about the Process of Recovery(QPR-J). Key secondary outcoms are PANSS: positive and negative syndrome scale)General Self-Efficacy Scale (GSES)Rosenberg Self Esteem Scale(RSES)Client Satisfaction Questionnaire (CSQ)-8.



Management information
Registered date
2018 Year 12 Month 04 Day
Last modified on
2018 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040043

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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