UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059627 |
|---|---|
| Receipt number | R000068204 |
| Scientific Title | The Relationship Between Emotional Experiencing Processes in Psychological Interviews and Interoceptive Sensitivity. |
| Date of disclosure of the study information | 2025/11/03 |
| Last modified on | 2025/11/03 20:07:35 |
* 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
The Relationship Between Emotional Experiencing Processes in Psychological Interviews and Interoceptive Sensitivity.
Acronym
The Relationship Between Emotional Experiencing Processes in Psychological Interviews and Interoceptive Sensitivity.
Scientific Title
The Relationship Between Emotional Experiencing Processes in Psychological Interviews and Interoceptive Sensitivity.
Scientific Title:Acronym
The Relationship Between Emotional Experiencing Processes in Psychological Interviews and Interoceptive Sensitivity.
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Basic Examination of Psychological Processes to Gain Insights into the Relationship Between the Body and Emotional Experience
Basic objectives2
Others
Basic objectives -Others
This study investigates the relationship between experiencing processes during psychotherapy and interoceptive sensitivity, using heartbeat perception tasks as an indicator of interoceptive accuracy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Experiencing Score (EXP Scale)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
semi-structured psychological interview
Participants underwent a 10-minute semi-structured simulated psychological interview, and immediately afterward, their subjective emotional experiences were assessed using the Experiencing Scale (EXP Scale).
The intervention was conducted once only and was not intended for therapeutic purposes but served as a basic examination of psychological processes.
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Being a healthy university student.
Able to provide written informed consent to participate in this study.
Key exclusion criteria
History of or current psychiatric disorders.
Having cardiovascular or other disorders that may affect the autonomic nervous system.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Kanbara |
Organization
Graduate School of Medicine/Faculty of Medicine, Kagawa University
Division name
Psychosomatic Medicine
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-898-5111
kambara.kenji@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kanbara |
Organization
Graduate School of Medicine/Faculty of Medicine, Kagawa University
Division name
Psychosomatic Medicine
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-898-5111
Homepage URL
kambara.kenji@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
No institution
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
Ethics Committee, Faculty of Medicine, Kagawa University
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
Tel
087-898-5111
kenkyushien-m@kagawa-u.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
| 2025 | Year | 11 | Month | 03 | Day |
Related information
URL releasing protocol
Not publicly available
Publication of results
Unpublished
Result
URL related to results and publications
Not publicly available
Number of participants that the trial has enrolled
20
Results
Experiential process scores correlated positively with heartbeat perception, showing higher interoception links to deeper experiences. Multiple regression indicated heartbeat perception predicted experiential process scores after controlling for age and TAS-20. In negative emotion contexts, TAS-20 weakly negatively correlated with experiential process scores.
Results date posted
| 2025 | Year | 11 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adults, mean age 21.95 years, SD=0.89
Gender: 9 males, 11 females
No current medication, no psychiatric disorders
Participant flow
20 participants enrolled
Pre-interview assessment: heartbeat perception task and TAS-20 questionnaire
Conducted simulated psychological interviews
EXP ratings collected during interviews
All participants included in the analysis
Adverse events
None reported
Outcome measures
Primary outcome: EXP scores (total, positive EXP, negative EXP)
Secondary outcomes: Heartbeat perception score, TAS-20 score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2023 | 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
| 2025 | Year | 11 | Month | 03 | Day |
Last modified on
| 2025 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068204
