UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056151 |
|---|---|
| Receipt number | R000064156 |
| Scientific Title | Development of a Manual for the Use and Revision of Crisis Plans in Outpatient Treatment under the Medical Treatment and Supervision Act |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2026/01/21 16:25:42 |
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Basic information
Public title
Development of a Manual for the Use and Revision of Crisis Plans in Outpatient Treatment under the Medical Treatment and Supervision Act
Acronym
Development of a Manual for the Use and Revision of Crisis Plans in Outpatient Treatment under the Medical Treatment and Supervision Act
Scientific Title
Development of a Manual for the Use and Revision of Crisis Plans in Outpatient Treatment under the Medical Treatment and Supervision Act
Scientific Title:Acronym
Development of a Manual for the Use and Revision of Crisis Plans in Outpatient Treatment under the Medical Treatment and Supervision Act
Region
| Japan |
Condition
Condition
Individuals with a primary diagnosis of F2 (Schizophrenia, Schizotypal, and Delusional Disorders) or F3 (Mood Disorders) according to ICD-10, and in whom dementia is not suspected
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a manual for the use and revision of crisis plans in outpatient treatment, and to evaluate its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of voluntary and involuntary hospitalizations under the Mental Health and Welfare Act following transition to outpatient treatment.
Key secondary outcomes
<Outpatient Staff>
Level of understanding regarding the use of the crisis plan
Level of difficulty regarding the use of the crisis plan
Sense of efficacy regarding the use of the crisis plan
Level of understanding regarding the revision of the crisis plan
Level of difficulty regarding the revision of the crisis plan
Sense of efficacy regarding the revision of the crisis plan
Usefulness of the crisis plan
<Participants>
Level of understanding regarding the use of the crisis plan
Level of difficulty regarding the use of the crisis plan
Sense of efficacy regarding the use of the crisis plan
Level of understanding regarding the revision of the crisis plan
Level of difficulty regarding the revision of the crisis plan
Sense of efficacy regarding the revision of the crisis plan
Usefulness of the crisis plan
Presence or absence of participant's deterioration of condition
Presence or absence of participant's problematic behavior
Shared Decision-Making Scale
Recovery Scale
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Medical institutions will be randomly assigned as either intervention or control institutions. For the intervention institutions, training on the crisis plan manual will be conducted, followed by a six-month intervention based on the manual.
Interventions/Control_2
The control group will continue with treatment as usual. Since crisis plans are also used in usual treatment, it will be possible to evaluate the impact of the manual.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals with a primary diagnosis of F2 (Schizophrenia, Schizotypal, and Delusional Disorders) or F3 (Mood Disorders) according to ICD-10.
Key exclusion criteria
Individuals in whom dementia is not suspected, and whose condition and physical health have been evaluated by the multidisciplinary team to determine that there are no issues with their participation in the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Teruyuki |
| Middle name | |
| Last name | NOMURA |
Organization
Saigata Medical Center
Division name
Clinical Research Department
Zip code
9493193
Address
468-1 Saigata, Joetsu City, Niigata Prefecture
TEL
0255343131
teruyuki.nomura.ev@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Teruyuki |
| Middle name | |
| Last name | NOMURA |
Organization
Saigata Medical Center
Division name
Clinical Research Department
Zip code
9493193
Address
468-1 Saigata, Joetsu City, Niigata Prefecture
TEL
0255343131
Homepage URL
teruyuki.nomura.ev@mail.hosp.go.jp
Sponsor or person
Institute
Saigata Medical Center
Institute
Department
Personal name
Teruyuki NOMURA
Funding Source
Organization
National Center of Neurology and Psychiatry Research and Development Fund for Psychiatric and Neurological Disorders
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saigata Medical Center
Address
468-1 Saigata, Joetsu City, Niigata Prefecture
Tel
0255343131
teruyuki.nomura.ev@mail.hosp.go.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
| 2025 | 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
| 2024 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2030 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 14 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064156
