UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of Crisis intervention for patients who have serious mental illness: A randomized controlled trial
Acronym	Effectiveness of Crisis intervention for patients who have serious mental illness: A randomized controlled trial
Scientific Title	Effectiveness of Crisis intervention for patients who have serious mental illness: A randomized controlled trial
Scientific Title:Acronym	Effectiveness of Crisis intervention for patients who have serious mental illness: A randomized controlled trial
Region	Japan

Condition
Condition	Schizophrenia Spectrum disorders, Mood disorders, Anxiety disorders, Trauma and Stressor related disorders, Substance use disorders
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assess effectiveness and safety of crisis intervention to patient who have serious mental illness
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Global Assessment Scale: GAS
Key secondary outcomes	Death Hospital admission Harm Economic cost Brief Psychiatric Rating Scale: BPRS Client Satisfaction Questionnaire: CSQ-8 EuroQuol 5 dimension quality of life measure: EQ-5D Life skills profile: LSP

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Home treatment Duration 14days Frequency 24hours Multidisciplinary team provide drug treatment, psychotherapy, basic living training, family intervention, education for patient in home or residential facility
Interventions/Control_2	Standard care Duration 14days Multidisciplinary team provide drug treatment, psychotherapy, basic living training, family intervention, education for patient in psychiatric hospital unit.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Person experiencing overwhelming stress due to a life event such as bereavement, rape or major illness finds that their usual coping mechanisms for everyday life break down. Patient diagnosed Schizophrenia Spectrum disorders, Mood disorders, Anxiety disorders, Trauma and Stressor related disorders, Substance use disorders Person consent of this study
Key exclusion criteria	Violent or suicide behavior Person need acute medical intervention Organic brain syndrome Mental retardation Dual diagnosis Drug and alcohol dependency Non resident of local area
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Takuro Middle name Last name Matsubara
Organization	Matsubara hospital
Division name	Department of psychiatry
Zip code	920-8654
Address	4-3-5 ishibiki, kanazawa city, Ishikawa Prefecture
TEL	0762314138
Email	takurou1@med.kanazawa-u.ac.jp

Public contact
Name of contact person	1st name Takuro Middle name Last name Matsubara
Organization	Matsubara Hosptal
Division name	Department of psychiatry
Zip code	920-8654
Address	4-3-5 ishibiki, kanazawa city, Ishikawa Prefecture
TEL	0762314138
Homepage URL
Email	takurou1@med.kanazawa-u.ac.jp

Sponsor
Institute	Matsubara hospital
Institute
Department

Funding Source
Organization	Matsubara hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Matsubara Hospital
Address	4-3-5 ishibiki, kanazawa city, Ishikawa Prefecture
Tel	0762314138
Email	takurou1@med.kanazawa-u.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	2021 Year 01 Month 01 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	Terminated
Date of protocol fixation	2020 Year 10 Month 26 Day
Date of IRB	2020 Year 10 Month 26 Day
Anticipated trial start date	2021 Year 01 Month 01 Day
Last follow-up date	2022 Year 01 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	2020 Year 10 Month 26 Day
Last modified on	2022 Year 10 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048223