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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029866
Receipt No. R000034109
Official scientific title of the study Development of cognitive behavior therapy program to reduce parenting stress
Date of disclosure of the study information 2018/11/07
Last modified on 2017/11/07

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Basic information
Official scientific title of the study Development of cognitive behavior therapy program to reduce parenting stress
Title of the study (Brief title) Development of cognitive behavior therapy program to reduce parenting stress
Region
Japan

Condition
Condition Pregnant women
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Develop programs based on cognitive behavioral therapy to alleviate child rearing stress.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We referred to cognitive behavioral therapy for depressed patients and created a program for childcare stress. The program will be improved based on opinions from pregnant women.
The first: When mothers' class is in the middle of pregnancy. The 2nd: When mothers' class is in the late pregnancy. Third time: during one month checkup.
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
Behavior,custom
Interventions/Control_1 We will conduct an hour's program for pregnant women visiting mothers' class.The first: When mothers' class is in the middle of pregnancy. The 2nd: When mothers' class is in the late pregnancy. Third time: during one month checkup.
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

Not applicable
Gender Female
Key inclusion criteria Pregnant women who can receive all three programs Pregnant women
Key exclusion criteria Pregnant women suffering from mental illness.
Target sample size 25

Research contact person
Name of lead principal investigator Sankai Chihoko
Organization University of Tsukuba Hospital
Division name Nursing Department
Address 2-1-1 Amakubo, Tsukuba, Ibaraki ,Japan
TEL 029-853-7671
Email sankaichihoko@ob.md.tsukuba.ac.jp

Public contact
Name of contact person Sankai Chihoko
Organization University of Tsukuba Hospital
Division name Nursing Department
Address 2-1-1 Amakubo, Tsukuba, Ibaraki ,Japan
TEL 029-853-7671
Homepage URL
Email sankaichihoko@ob.md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba Hospital
Institute
Department

Funding Source
Organization Japan Society for the promotion of Science

Ministry of education, Culture, Sports, Science and Technology - Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 椎名産婦人科(茨城県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 07 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 10 Month 17 Day
Anticipated trial start date
2017 Year 11 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2017 Year 11 Month 07 Day
Last modified on
2017 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034109

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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