UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056105 |
|---|---|
| Receipt number | R000059399 |
| Scientific Title | A Preliminary Randomized Controlled Trial with Healthy Subjects to Validate Interviewing Procedures for Self-Understanding |
| Date of disclosure of the study information | 2024/11/08 |
| Last modified on | 2024/11/08 16:47:37 |
* 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
A Preliminary Randomized Controlled Trial with Healthy Subjects to Validate Interviewing Procedures for Self-Understanding
Acronym
Randomized Interview Study for Experiencing: RISE study
Scientific Title
A Preliminary Randomized Controlled Trial with Healthy Subjects to Validate Interviewing Procedures for Self-Understanding
Scientific Title:Acronym
A Preliminary Randomized Controlled Trial with Healthy Subjects to Validate Interviewing Procedures for Self-Understanding
Region
| Japan |
Condition
Condition
Healthy control
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to conduct a preliminary randomized controlled trial to assess the effectiveness of a validation procedure for interviewer listening, grounded in the Focusing approach, using healthy controls as participants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of occurrence of EXP scale during QOL interview
Key secondary outcomes
1. Mean change in SEIQoL-DW pre- and post-interview scores.
2. Mean change in PANAS pre- and post-interview scores.
3. Mean change in CORE-OM pre- and post-interview scores.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Content: Interviews featuring questions predicated on the EXP scale score of 3 or higher.
Frequency: Once
Interventions/Control_2
Content: Interviews featuring questions based on the EXP scale score of 2 or lower.
Frequency: Once
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
Individuals who are not presently receiving care at a psychiatric institution.
Key exclusion criteria
(1) Individuals who predominantly use a language other than their native language or Japanese in their daily activities.
(2) Participants who encounter challenges when conducting semi-structured interviews.
(3) Other potential subjects identified as unsuitable research participants by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Koshikawa |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry
Zip code
570-8507
Address
10-15 fumizono-cho, Moriguchi city, Osaka
TEL
06-6992-1001
foqsj2018@gmail.com
Public contact
Name of contact person
| 1st name | Ysouke |
| Middle name | |
| Last name | Koshikawa |
Organization
Kansai Medical University
Division name
Department of Neuropsychiatry
Zip code
570-8507
Address
10-15 fumizono-cho, Moriguchi city, Osaka
TEL
06-6992-1001
Homepage URL
foqsj2018@gmail.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Kansai Medical University Center for Ethical Review
Address
2-5-1, Shin-machi, Hirakata city, Osaka
Tel
072-804-2440
rinriirb@hirakata.kmu.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
関西医科大学総合医療センターほか
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 08 | 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
| 2024 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2024 | Year | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059399
