UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035131
Receipt number R000040043
Scientific Title 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 2019/12/13 11:37:08

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Basic information

Public title

Prospective observational study on factors associated with personal recovery for inpatients with psychotic disorders

Acronym

Prospective observational study on factors associated with personal recovery for inpatients with psychotic disorders

Scientific Title

Prospective observational study on factors associated with personal recovery for inpatients with psychotic disorders

Scientific Title:Acronym

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

1st name Norika
Middle name
Last name Mitsunaga

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Psychiatric Nursing

Zip code

9800875

Address

2-1,Seiryo-machi, Aoba-Ku, Sendai, 980-8575, Japan

TEL

0227177916

Email

mitsuanga@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Norika
Middle name
Last name Mitsunaga

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Psychiatric Nursing

Zip code

9808574

Address

2-1,Seiryo-machi, Aoba-Ku, Sendai, 980-8575, Japan

TEL

022-717-7916

Homepage URL


Email

mitsuanga@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tohoku University Graduate School of Medicine

Address

2-1,Seiryo-machi, Aoba-Ku, Sendai, 980-8575, Japan

Tel

0227177916

Email

mitsunaga@med.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



Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 07 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

40

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

Completed

Date of protocol fixation

2018 Year 12 Month 01 Day

Date of IRB

2018 Year 11 Month 26 Day

Anticipated trial start date

2019 Year 01 Month 16 Day

Last follow-up date

2020 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

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

2019 Year 12 Month 13 Day



Link to view the page

Value
https://center6.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