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
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
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
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
