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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042237
Receipt No. R000048223
Scientific Title Effectiveness of Crisis intervention for patients who have serious mental illness: A randomized controlled trial
Date of disclosure of the study information 2021/01/01
Last modified on 2020/10/26

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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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 26 Day
Date of IRB
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
2020 Year 10 Month 26 Day


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

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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