UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040464 |
|---|---|
| Receipt number | 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 17:52:29 |
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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
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
rcbtdst@gmail.com
Sponsor or person
Institute
Musashino University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
