UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059979 |
|---|---|
| Receipt number | R000068508 |
| Scientific Title | Effect of Brief Sleep Cognitive Behavioral Therapy on Preventing Depression in Postpartum Couples: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/12/18 |
| Last modified on | 2025/12/18 14:36:17 |
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Basic information
Public title
Effect of Brief Sleep Cognitive Behavioral Therapy on Preventing Depression in Postpartum Couples: A Randomized Controlled Trial
Acronym
Effect of Brief Sleep Cognitive Behavioral Therapy on Preventing Depression in Postpartum Couples: A Randomized Controlled Trial
Scientific Title
Effect of Brief Sleep Cognitive Behavioral Therapy on Preventing Depression in Postpartum Couples: A Randomized Controlled Trial
Scientific Title:Acronym
Effect of Brief Sleep Cognitive Behavioral Therapy on Preventing Depression in Postpartum Couples: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Healthy pregnant women and their husbands or partners
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To develop a brief cognitive behavioral therapy for insomnia program (brief CBT-I program) for couples from pregnancy through the postpartum period.
2. To evaluate the effectiveness of the developed brief CBT-I program in reducing postpartum depression among postpartum couples through a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postpartum depression among couples at 3 months postpartum (Assessed by EPDS and PHQ-9)
Key secondary outcomes
1.Postpartum depression among couples at 9 months pregnant (Assessed by EPDS and PHQ-9)
2.Insomunia among couples at 9 months pregnant and 3 months postpartum (Assessed by ISI)
3.Anxiety among couples at 9 months pregnant and 3 months postpartum (Assessed by GAD-7)
4.Marital satisfaction among couples at 9 months pregnant and 3 months postpartum (Assessed by QMI)
5.Bonding to infant among couples at months postpartum (Assessed by MIBS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
At 8 months of pregnancy (first intervention), participants will be asked to watch a video-based brief CBT-I program consisting of sleep hygiene education, sleep restriction therapy, stimulus control therapy, and relaxation techniques.
The program also includes content on physiological changes during pregnancy, sleep alterations in pregnant women, sex differences in sleep, and lifestyle changes.
Interventions/Control_2
At 1 month postpartum (second intervention), participants will be asked to watch a video-based brief CBT-I program consisting of sleep hygiene education, sleep restriction therapy, stimulus control therapy, and relaxation techniques.
In addition to reviewing the content from the first prenatal session, the program also includes information on understanding newborn nighttime awakenings, as well as postpartum daily life and strategies for securing adequate sleep.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Couples who participate in municipal maternal-child health services or visit a hospital/clinic between October 1, 2025, and June 30, 2026.
2. Couples in which both partners are 18 years or older.
3. Couples in which the pregnant partner is between 4 and 8 months of gestation.
4. Couples with an expected delivery date between April 2, 2026, and August 5, 2026.
5. Couples who have concerns or interests regarding sleep.
6. Couples who receive an explanation of the study and provide informed consent to participate.
Note: Couples are defined as a man and a woman who will share childbirth and child-rearing, regardless of legal marital status.
Key exclusion criteria
1. Couples in which either partner is currently receiving psychiatric or psychosomatic medical care.
2. Couples with a multiple pregnancy.
3. Couples in which only one partner can participate in the study.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Tanaka |
Organization
kitasato University
Division name
School of Nursing
Zip code
252-0373
Address
1-15-1 Kitazato, Minami, Sagamihara, Kanagawa
TEL
042-778-9243
mktanaka@nrs.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Matsunaga |
Organization
Tokyo Women's Medical University
Division name
Center for Medical and Nursing Education
Zip code
162-8666
Address
Kawadacho 8-1, Shinjuku, Tokyo
TEL
03-3353-8111
Homepage URL
matsunaga.shota@twmu.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokai University, Tokyo Women's Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Nursing Research Ethics Committee
Address
1-15-1 Kitazato, Minami, Sagamihara, Kanagawa
Tel
042-778-8111
ttsukada@kitasato-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
| 2025 | Year | 12 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068508
