UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055316 |
|---|---|
| Receipt number | R000063203 |
| Scientific Title | The effect of Digital brief behavioral therapy for insomnia (dBBT-I) for women and the partners until 2nd trimester in pregnancy: Cluster Randomized controlled trial |
| Date of disclosure of the study information | 2024/08/23 |
| Last modified on | 2024/08/22 15:38:09 |
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Basic information
Public title
The effect of Digital brief behavioral therapy for insomnia (dBBT-I) for women and the partners until 2nd trimester in pregnancy: Cluster Randomized controlled trial
Acronym
The effect of Digital brief behavioral therapy for insomnia (dBBT-I) for women and the partners until 2nd trimester in pregnancy: Cluster Randomized controlled trial
Scientific Title
The effect of Digital brief behavioral therapy for insomnia (dBBT-I) for women and the partners until 2nd trimester in pregnancy: Cluster Randomized controlled trial
Scientific Title:Acronym
The effect of Digital brief behavioral therapy for insomnia (dBBT-I) for women and the partners until 2nd trimester in pregnancy: Cluster randomized controlled trial
Region
| Japan |
Condition
Condition
Maternal and Postpartum Sleep Disorder/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 test the effectiveness of dBBT-I by conducting a digital Brief Behavioral Therapy for Insomnia (dBBT-I) in first-time pregnant women and their partners in the second trimester and following them for insomnia and mental health until 4 months postpartum.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the Athens Insomnia Scale (AIS) scores before intervention (the 2nd trimester of pregnancy) and the 3rd trimester.
Key secondary outcomes
The following scales for women and partners at baseline (2nd trimester), immediately after intervention, 1 month after intervention, 3rd trimester, 1 month postpartum, and 4 months postpartum;
1 Athens Insomnia Scale
2 Edinburgh Postnatal Depression Scale (EPDS)
3 The Circadian Energy Scale (CIRENS)
4 Restorative Sleep Questionnaire (RSQ)
5 Sleep Debt Index (SDI)
6 Ford Insomnia Response to Stress Test (FIRST)
7 Cambridge-Hopkins RLS Short Form questionnaire 13 (CH-RLSq13) version 2.16
8 Three-Item Loneliness Scale
9 Generalized Anxiety Disorder-7 (GAD-7)
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
| Device,equipment | Behavior,custom |
Interventions/Control_1
The intervention group in this study will use the NEC Personal Sleep Coach, which is a sleep improvement program as a digital brief behavioural therapy for insomnia (dBBT-I).
In the intervention group, a pre-intervention questionnaire will be conducted before the intervention, and a 2-week dBBT-I program will be administered around 25 weeks gestation. The questionnaires will be given after intervention: immediately after intervention, one month, late third trimester, one month postpartum, and four months postpartum. All questionnaires are web-based questionnaires.
Interventions/Control_2
In the control group, the questionnaires will be conducted at the same periods in maternal and postpartum questionnaires 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
Male and Female
Key inclusion criteria
Singleton, low risk primiparas and their partners, and can understand Japanese.
Key exclusion criteria
Pregnancies with serious complications (cardiac, hematological, autoimmune, etc.)
Pregnancies with serious fetal complications (fetal malformations, chromosomal abnormalities, etc.)
Persons with any kind of sleep or wakefulness disorder, Persons undergoing treatment for mental illness.
Multipara
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoriko |
| Middle name | |
| Last name | Kotoku |
Organization
Nagasaki University
Division name
Institute of Biomedical Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki, 852-8520, Japan
TEL
095-819-7952
y-kotoku@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoriko |
| Middle name | |
| Last name | Kotoku |
Organization
Nagasaki University
Division name
Institute of Biomedical Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki, 852-8520, Japan
TEL
095-819-7952
Homepage URL
y-kotoku@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science (JSPS)
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 of Biomedical Sciences, General Affairs Division, Research Support Section
Address
1-12-4 Sakamoto, Nagasaki, 852-8520, Japan
Tel
095-819-7198
gakujutu_gakuji@ml.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
| 2024 | Year | 08 | Month | 23 | 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 | 12 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 08 | Month | 23 | Day |
Last modified on
| 2024 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063203
