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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040464
Receipt No. R000046185
Scientific Title Research on the effectiveness of dialogue skill training (CBT-DST) utilizing cognitive behavioral therapy for the perinatal period.
Date of disclosure of the study information 2020/05/20
Last modified on 2020/05/20

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Basic information
Public title Research on the effectiveness of dialogue skill training (CBT-DST) utilizing cognitive behavioral therapy for the perinatal period.
Acronym Effectiveness of dialogue skill
training (CBT-DST) utilizing
cognitive behavioral therapy for
the perinatal period.
Scientific Title Research on the effectiveness of dialogue skill training (CBT-DST) utilizing cognitive behavioral therapy for the perinatal period.
Scientific Title:Acronym Effectiveness of dialogue skill
training (CBT-DST) utilizing
cognitive behavioral therapy for
the perinatal period.
Region
Japan

Condition
Condition Professionals working in the perinatal period: doctors, midwives,
public health nurses, nurses, psychologists, Preschool teacher.
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to verify the effects and changes of dialogue skill training utilizing
cognitive behavioral therapy for
professionals involved in
perinatal support.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Self-efficacy regarding dialogue
Key secondary outcomes 1. General Self-Efficacy Scale(GSE)
2. Self-efficacy regarding support for mental health
3. Recognition of mental health
4. Training program evaluation
5. Impression

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 dialogue skill training
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Participants who give full consent in the participation
of the study.
2) Over 20 years old.
3) Participants who can understand Japanese.
Key exclusion criteria 1) Others who have been determined ineligible by principal investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ayako
Middle name
Last name Kanie
Organization National Center of Neurology and Psychiatry
Division name National Center of Cognitive-Behavior Therapy and Research
Zip code 187-8551
Address 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan, 187-8551
TEL +81-42-341-2711
Email rcbtdst@gmail.com

Public contact
Name of contact person
1st name Miyuki
Middle name
Last name Makino
Organization Musashino University
Division name Institution of Cognitive Behavioral Therapy and Research
Zip code 135-8181
Address 3-3-3 Ariake, Koto-ku, Tokyo, JAPAN
TEL 03-5530-7403
Homepage URL
Email rcbtdst@gmail.com

Sponsor
Institute Musashino University
Institute
Department

Funding Source
Organization KAKENHI Grants-in-aid for
Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor National Center of Neurology and Psychiatry
Name of secondary funder(s)

IRB Contact (For public release)
Organization Administration Department, Musashino University
Address Ariake 3-3-3,Koto-Ku,Tokyo,Japan
Tel 03-5530-7695
Email a_gakubu@musashino-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
2020 Year 05 Month 20 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 Enrolling by invitation
Date of protocol fixation
2020 Year 01 Month 08 Day
Date of IRB
2020 Year 01 Month 08 Day
Anticipated trial start date
2020 Year 01 Month 17 Day
Last follow-up date
2022 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
2020 Year 05 Month 20 Day
Last modified on
2020 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046185

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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