UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049393 |
|---|---|
| Receipt number | R000056241 |
| Scientific Title | An investigation of the differential effects of cognitive restructuring and cognitive defusion on reducing aggressive behavior toward significant others. |
| Date of disclosure of the study information | 2022/11/07 |
| Last modified on | 2022/11/01 18:02:22 |
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Basic information
Public title
An investigation of the differential effects of cognitive restructuring and cognitive defusion on reducing aggressive behavior toward significant others.
Acronym
An investigation of the differential effects of cognitive restructuring and cognitive defusion on reducing aggressive behavior toward significant others.
Scientific Title
An investigation of the differential effects of cognitive restructuring and cognitive defusion on reducing aggressive behavior toward significant others.
Scientific Title:Acronym
An investigation of the differential effects of cognitive restructuring and cognitive defusion on reducing aggressive behavior toward significant others.
Region
| Japan |
Condition
Condition
Aggressive behavior
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of cognitive restructuring and cognitive defusion on the reduction of verbal abuse and violence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of verbal and violent assaults in the past week
Degree of aggression
Degree of emotional control
Degree of cognitive fusion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
Cognitive defusion for one week
Interventions/Control_2
Cognitive restructuring for one week
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
Must be able to operate an online conferencing system using a personal computer, etc.; must be able to prepare a personal computer, etc. with a camera and microphone at home; must have experience in verbal abuse or violence (including minor verbal altercations, swearing, etc.) toward those close to them.
Key exclusion criteria
Must be using a medical facility for mental health problems.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Nomura |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
Kitasato1-15-1, Minami ku, Sagamihara city, Kanagawa prefecture
TEL
042-778-9389
nomura.kazutaka@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Nomura |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
Kitasato1-15-1, Minami ku, Sagamihara city, Kanagawa prefecture
TEL
042-778-9389
Homepage URL
nomura.kazutaka@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Wayo Women's University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of Kitasato University School of Allied Health Sciences
Address
1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan
Tel
0427789602
a-soumu@kitasato-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
| 2022 | Year | 11 | Month | 07 | 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
| 2022 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 23 | 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
| 2022 | Year | 11 | Month | 01 | Day |
Last modified on
| 2022 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056241
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
