UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052438 |
|---|---|
| Receipt number | R000059851 |
| Scientific Title | Intervention and Effectiveness of Cognitive Behavioral Therapy (dCBT-I) for Maternal Insomnia in Late Pregnancy to 4 Months Postpartum |
| Date of disclosure of the study information | 2023/10/07 |
| Last modified on | 2024/01/14 15:35:22 |
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Basic information
Public title
Intervention and Effectiveness of Cognitive Behavioral Therapy (dCBT-I) for Maternal Insomnia in Late Pregnancy to 4 Months Postpartum
Acronym
Intervention and Effectiveness of Cognitive Behavioral Therapy (dCBT-I) for Maternal Insomnia in Late Pregnancy to 4 Months Postpartum
Scientific Title
Intervention and Effectiveness of Cognitive Behavioral Therapy (dCBT-I) for Maternal Insomnia in Late Pregnancy to 4 Months Postpartum
Scientific Title:Acronym
Intervention and Effectiveness of Cognitive Behavioral Therapy (dCBT-I) for Maternal Insomnia in Late Pregnancy to 4 Months Postpartum
Region
| Japan |
Condition
Condition
Maternal Insomnia
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of dCBT-I intervention in late pregnancy to 4 months postpartum on subsequent sleep and anxiety, fatigue, etc.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intervention effectiveness of the dCBT-I programme and Athens Insomnia Scale scores.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention in this study will use the dCBT-I program application. This app will use a personal sleep coach developed by NEC.
In the intervention group, the first pre-intervention Web survey will be administered, the 2-week CBT-I program will be administered around 34-35 weeks of pregnancy, the second post-intervention Web questionnaire will be administered around 36-37 weeks of pregnancy, the third Web questionnaire will be administered at 1 month postpartum, and the fourth Web questionnaire will be administered at 4 months postpartum.
Interventions/Control_2
In the control group, the first web questionnaire will be administered at around 34-35 weeks, the second at 36-37 weeks, and the third and fourth at 1 month and 4 months postpartum, respectively, at the same time as the intervention group.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
singleton, pregnant women who can understand Japanese
Key exclusion criteria
Pregnancies with serious complications (cardiac, hematological, autoimmune, etc.)
Pregnancies with serious fetal complications (fetal malformations, chromosomal abnormalities, etc.)
Stillbirth or neonatal death
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | Kaguchi |
Organization
Nagasaki University Graduate School
Division name
Division of Nursing Science, Department of Medical Science, Graduate School of Biomedical Sciences
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki City, Nagasaki
TEL
095-819-7000
bb55322011@ms.nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Kaguchi |
Organization
Kobe City College of Nursing
Division name
Women's Health Nursing and Midwifery
Zip code
651-2103
Address
3-4, Gakuen-Nishi-machi, Nishi-ku, Kobe City, Hyogo
TEL
078-794-8085
Homepage URL
kaguchi@kobe-ccn.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
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)
IRB Contact (For public release)
Organization
Nagasaki University Graduate School
Address
1-12-4 Sakamoto, Nagasaki City, Nagasaki
Tel
095-819-7000
bb55322011@ms.nagasaki-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
| 2023 | Year | 10 | Month | 07 | 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
| 2023 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 10 | 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
| 2023 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059851
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
