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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042859
Receipt No. 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 2021/06/29

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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
Email 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
Email m-eguchi@kobe-tokiwa.ac.jp

Sponsor
Institute Kobe-Tokiwa University
Institute
Department

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
Email 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 37
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 No longer recruiting
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 03 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 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048922

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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