UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042237
Receipt number 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 2022/10/28 12:03:05

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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 or person

Institute

Matsubara hospital

Institute

Department

Personal name



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

Value
https://center6.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