UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057735 |
|---|---|
| Receipt number | R000065715 |
| Scientific Title | Prospective observational study on "Kokoro Care", a recovery-oriented psychiatric short-care program |
| Date of disclosure of the study information | 2025/04/29 |
| Last modified on | 2025/10/29 12:35:43 |
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Basic information
Public title
Prospective observational study on "Kokoro Care", a recovery-oriented psychiatric short-care program
Acronym
Prospective observational study on "Kokoro Care", a recovery-oriented psychiatric short-care program
Scientific Title
Prospective observational study on "Kokoro Care", a recovery-oriented psychiatric short-care program
Scientific Title:Acronym
Prospective observational study on "Kokoro Care", a recovery-oriented psychiatric short-care program
Region
| Japan |
Condition
Condition
All psychiatric disorders in adults
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the discontinuation rate, satisfaction with the program, and changes in participants' recovery process by prospectively observing the "Kokoro Care" program, which is offered as a short-care program at the Psychiatric Rehabilitation Department of National Center Hospital, National Center of Neurology and Psychiatry.
Basic objectives2
Others
Basic objectives -Others
Discontinuation rate, satisfaction with the program.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Program discontinuation rate, satisfaction, and change in Flourish Scale and UCLA Loneliness Scale between pre-treatment (1st session) and at 14th session.
Key secondary outcomes
1. Change in Clinical Global Impressions-severity of illness (CGI-S) at the 14th session compared to before the start of treatment (the 1st session).
2. Clinical Global Impressions-improvement scale (CGI-I) at the 14th session compared to the baseline (1st session).
3. Subjective importance regarding the program.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients 18 years of age or older who have participated in the "Kokoro Care" program during the study period and have stable capacity to make a decision to participate in the study (i.e., have the ability to consent).
Key exclusion criteria
None.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Toshitaka |
| Middle name | |
| Last name | Hamamura |
Organization
National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry
Division name
Department of Training
Zip code
187-8551
Address
4-1-1 Ogawahigashimachi, Kodaira-shi, Tokyo, Japan
TEL
042-341-2711
thamamura@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Airi |
| Middle name | |
| Last name | Kato |
Organization
National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychi
Division name
Department of Training
Zip code
187-8551
Address
4-1-1 Ogawahigashimachi, Kodaira-shi, Tokyo, Japan
TEL
042-341-2711
Homepage URL
kato.a-md@ncnp.go.jp
Sponsor or person
Institute
National Research and Development Agency National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Research and Development Agency National Center of Neurology and Psychiatry
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
Institutional Review Board at National Center Hospital for Neurology and Psychiatry
Address
4-1-1 Ogawahigashimachi, Kodaira-shi, Tokyo, Japan
Tel
042-341-2711
rinri-jimu@ncnp.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 | 04 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study.The subjects are patients aged 18 and over who have received the "Kokoro Care" program at the National Center of Neurology and Psychiatry Hospital and have given written consent.The research period is from February 20, 2025 to March 31, 2030, as approved by the ethics committee. Information to be collected will be the Flourish Scale, UCLA Loneliness Scale, CGI-S and CGI-I, questionnaires (satisfaction, subjective importance, and free writing), and discontinuation rate, which are administered within the usual practice, as well as participants' gender, age, diagnosis, and severity from electronic medical records. In addition, a preliminary questionnaire will be administered to collect information on marital history, hospitalization history, family members living with the patient, employment experience, past use of social resources, current use of social resources, and history of specialized treatment in the past 3 months.
Management information
Registered date
| 2025 | Year | 04 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065715
