UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061063 |
|---|---|
| Receipt number | R000069870 |
| Scientific Title | An Observational Study on the Epidemiology of Psychosomatic Conditions and the Effectiveness and Safety of Psychosomatic Approach |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/03/26 09:01:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An Observational Study on the Epidemiology of Psychosomatic Conditions and the Effectiveness and Safety of Psychosomatic Approach
Acronym
PSY-CARE Study
Scientific Title
An Observational Study on the Epidemiology of Psychosomatic Conditions and the Effectiveness and Safety of Psychosomatic Approach
Scientific Title:Acronym
PSY-CARE Study
Region
| Japan |
Condition
Condition
Patients with psychosomatic tendencies
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the clinical and psychosocial profiles of patients with psychosomatic tendencies and evaluates changes in quality of life and interoceptive awareness after a psychosomatic approach.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the total WHOQOL-26 score from baseline to 2 months after treatment initiation
Key secondary outcomes
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consecutive patients attending their first visit to psychosomatic medicine departments at participating hospitals will be enrolled during the study period.
Key exclusion criteria
Patients with psychiatric disorders that impair communication, such as cognitive dysfunction, and who are judged to have difficulty participating in the study
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine, Kansai Medical University
Zip code
573-1010
Address
2-5-1-505 Shinmachi, Hirakata
TEL
0728040101
h.hasuo7@gmail.com
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
573-1010
Address
2-5-1-505 Shinmachi, Hirakata
TEL
0728040101
Homepage URL
h.hasuo7@gmail.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Hideaki Hasuo
Funding Source
Organization
Self funding
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
Department of Psychosomatic Medicine, Kansai Medical University
Address
2-5-1-505 Shinmachi, Hirakata
Tel
0728040101
h.hasuo7@gmail.com
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 | 06 | 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
| 2026 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2026 | Year | 03 | Month | 26 | Day |
Last modified on
| 2026 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069870
