UMIN-CTR Clinical Trial

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