UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055394 |
|---|---|
| Receipt number | R000063301 |
| Scientific Title | The Impact of Validating and Invalidating Responses on Emotional Reactivity -the effect of emotion dysregulation, alexithymia and alexisomia- |
| Date of disclosure of the study information | 2024/09/02 |
| Last modified on | 2025/01/29 12:51:47 |
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Basic information
Public title
The Impact of Validating and Invalidating Responses on Emotional Reactivity -the effect of emotion dysregulation, alexithymia and alexisomia-
Acronym
The Impact of Validating and Invalidating Responses on Emotional Reactivity -the effect of emotion dysregulation, alexithymia and alexisomia-
Scientific Title
The Impact of Validating and Invalidating Responses on Emotional Reactivity -the effect of emotion dysregulation, alexithymia and alexisomia-
Scientific Title:Acronym
The Impact of Validating and Invalidating Responses on Emotional Reactivity -the effect of emotion dysregulation, alexithymia and alexisomia-
Region
| Japan |
Condition
Condition
Emotion dysregulation
Complex Post-Traumatic Stress Disorder
Borderline Personality Disorder
Dissociative Disorders
Healthy adults
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of validating and invalidating responses on emotional reactivity in view of individual differences in emotion dysregulation, alexithymia and alexisomia tendencies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart Rate
Time points: pre-intervention (baseline), postintervention
Key secondary outcomes
PANAS(Positive and Negative Affect Schedule)
Time points: pre-intervention (baseline), postintervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants complete a set of mental arithmetic task as a cognitive stressor, describe their emotional experience, and then receive a set of validating responses.
Interventions/Control_2
Participants complete a set of mental arithmetic task as a cognitive stressor, describe their emotional experience, and then receive a set of invalidating responses.
Interventions/Control_3
Participants complete a set of mental arithmetic task as a cognitive stressor, describe their emotional experience.
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
Healthy adult
Key exclusion criteria
none
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Nakanishi |
Organization
Suzuka University of Medical Science
Division name
Faculty of Health Science Department of Medical Welfare
Zip code
513-0293
Address
1001-1 Kishioka-cho, Suzuka-city, Mie 513-0293
TEL
059-383-9208
nakaken@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Nakanishi |
Organization
Suzuka University of Medical Science
Division name
Faculty of Health Science Department of Medical Welfare
Zip code
510-0293
Address
1001-1 Kishioka-cho, Suzuka-city, Mie 513-0293
TEL
059-383-9208
Homepage URL
nakaken@suzuka-u.ac.jp
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
none
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
Suzuka University of Medical Science the ethics committees of clinical researches
Address
1001-1 Kishioka-cho, Suzuka-city, Mie 513-0293
Tel
059-383-9208
nakaken@suzuka-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
鈴鹿医療科学大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 02 | 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 | 06 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2027 | 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 | 09 | Month | 02 | Day |
Last modified on
| 2025 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063301
