UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061207 |
|---|---|
| Receipt number | R000069933 |
| Scientific Title | Development of Early Support for Recovery in Individuals with Psychiatric and Neurodevelopmental Disorders |
| Date of disclosure of the study information | 2026/04/10 |
| Last modified on | 2026/04/06 11:14:51 |
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Basic information
Public title
Development of Early Support for Recovery in Individuals with Psychiatric and Neurodevelopmental Disorders
Acronym
Early Support for Recovery in Individuals with Psychiatric and Neurodevelopmental Disorders
Scientific Title
Development of Early Support for Recovery in Individuals with Psychiatric and Neurodevelopmental Disorders
Scientific Title:Acronym
Early Support for Recovery in Individuals with Psychiatric and Neurodevelopmental Disorders
Region
| Japan |
Condition
Condition
Psychiatric and Neurodevelopmental Disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a brief support aimed at promoting recovery among patients in the early stages of mental health problems.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scale for recovery, engagement and agency
Key secondary outcomes
Scale for depression and anxiety, quality of life, psychotic like experience, resilience, and social support
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A brief psychosocial intervention aimed at promoting recovery
Interventions/Control_2
Treatment as usual
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
| 12 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
12 to 30 years
Patients with mental disorders
Key exclusion criteria
Inability to communicate in Japanese
Presence of organic brain disorder requiring treatment
Presence of physical disorder requiring inpatient treatment
Subject to behavioral restrictions (seclusion or physical restraint) under the Mental Health and Welfare Act
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Tada |
Organization
The University of Tokyo Hospital
Division name
Department of Neuropsychiatry
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
tadam-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Usui |
Organization
The University of Tokyo Hospital
Division name
Department of Neuropsychiatry
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
usuikaori08@gmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Human Research Studies(OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2026 | Year | 04 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 09 | Day |
Last modified on
| 2026 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069933
