UMIN-CTR Clinical Trial

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