UMIN-CTR Clinical Trial

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