UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042859 |
|---|---|
| Receipt number | R000048922 |
| Scientific Title | Effect of the cognitive behavioral therapy program as nursing intervention to rumination -use a parallel group comparison study- |
| Date of disclosure of the study information | 2021/03/15 |
| Last modified on | 2021/12/27 16:55:04 |
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Basic information
Public title
Effect of the cognitive behavioral therapy program as nursing intervention to rumination -use a parallel group comparison study-
Acronym
Effect of the cognitive behavioral therapy program as nursing intervention to rumination -use a parallel group comparison study-
Scientific Title
Effect of the cognitive behavioral therapy program as nursing intervention to rumination -use a parallel group comparison study-
Scientific Title:Acronym
Effect of the cognitive behavioral therapy program as nursing intervention to rumination -use a parallel group comparison study-
Region
| Japan |
Condition
Condition
Under the depression
Classification by specialty
| Geriatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of research is examining the effect of "the group cognitive-behavioral-therapy program (awareness) as nursing intervention to reflection."
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rumination
Key secondary outcomes
Mood
Cognitive bias
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A participant participates in a program (60 minutes and all the 8 times), and does homework (the breathing method) every day.
Interventions/Control_2
Non-intervention.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Person who has depressed mood.
person who can participate in a program 80 percent or more.
Key exclusion criteria
Person who have a critical body disease.
Person who are carrying out meditation and mindfulness daily.
Person who cannot do a Japanese understanding sufficiently.
Dementia.
Person who has serious suicide ideation, suicide related behavior.
Personality disorder
Doctor dose not agree.
The person whom the researcher judged to be unsuitable to participation of research.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Miki |
| Middle name | |
| Last name | Eguchi |
Organization
Kobe-Tokiwa University
Division name
Department of Nursing, Faculty of Health Science
Zip code
653-0838
Address
2-6-2Ootani-tyou nagata kobe
TEL
078-611-1821
m-eguchi@kobe-tokiwa.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Eguchi |
Organization
Kobe-Tokiwa University
Division name
Department of Nursing, Faculty of Health Science
Zip code
653-0838
Address
2-6-2Ootani-tyou nagata kobe
TEL
078-611-1821
Homepage URL
m-eguchi@kobe-tokiwa.ac.jp
Sponsor or person
Institute
Kobe-Tokiwa University
Institute
Department
Personal name
Funding Source
Organization
Kobe Tokiwa University
Grants Aid Scientific Research
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
Kobe-Tokiwa University
Address
2-6-2Ootani-tyou nagata kobe
Tel
078-611-1821
m-eguchi@kobe-tokiwa.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
| 2021 | Year | 03 | Month | 15 | 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
30
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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 26 | Day |
Last modified on
| 2021 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048922
| 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 |
