UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061209 |
|---|---|
| Receipt number | R000070037 |
| Scientific Title | Effectiveness of a One-Day In-Person and Online CBT Workshop for Preventing Perinatal Depression Among Expectant Couples: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/04/09 |
| Last modified on | 2026/04/09 09:24:56 |
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Basic information
Public title
Preventing Perinatal Depression in Expectant Couples: A Randomized Controlled Trial of One-Day CBT Workshops via In-person and Online Delivery
Acronym
Preventing Perinatal Depression Through Workshops for Expectant Couples
Scientific Title
Effectiveness of a One-Day In-Person and Online CBT Workshop for Preventing Perinatal Depression Among Expectant Couples: A Randomized Controlled Trial
Scientific Title:Acronym
Preventive Effect of One-Day CBT for Perinatal Depression in Expectant Couples: An RCT
Region
| Japan |
Condition
Condition
NA
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the preventive effects of a "One-Day Cognitive Behavioral Therapy (CBT)" on perinatal depression among expectant couples using a randomized controlled trial. The program is designed for both in-person and online delivery. Beyond evaluating the efficacy of these two formats, the study seeks to clarify their respective strengths and limitations, as well as to develop strategic improvements for their practical application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depressive symptoms in mothers and fathers at 4 and 8 weeks postpartum
Key secondary outcomes
Anxiety
Mental health status
Loneliness
Sleep
Marital satisfaction
Work life balance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
One-Day CBT in person
Interventions/Control_2
Online One-Day CBT
Interventions/Control_3
Watching mental health-related videos
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Depressive symptoms in the pregnant woman are subthreshold (Patient Health Questionnaire-9 [PHQ-9] score <9).
(2) Depressive symptoms in the partner/father are subthreshold (PHQ-9 score <9).
(3) The pregnant woman is aged between 20 and 49 years (no age requirement for the partner).
(4) The pregnant woman is between 20 and 36 weeks of gestation.
(5) Proficiency in understanding, reading, and writing Japanese.
Key exclusion criteria
(1) Either the woman or her partner is currently receiving psychiatric or psychosomatic medical treatment.
(2) High-risk pregnancy, including but not limited to threatened miscarriage, threatened premature labor, placenta previa, severe pregnancy-induced hypertension, or multiple gestation.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Satomi |
| Middle name | Kato |
| Last name | Doi |
Organization
Institute of Science Tokyo
Division name
Department of Health Policy
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4031
doi.hlth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | Kato |
| Last name | Doi |
Organization
Institute of Science Tokyo
Division name
Department of Health Policy
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4031
Homepage URL
doi.hlth@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Kato
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Rikkyo University
Name of secondary funder(s)
Ministry of Education, Culture, Sports, Science and Technology
IRB Contact (For public release)
Organization
Research Ethics Group, Research Infrastructure Promotion Division, Department of Research Advancement, Institute of Science Tokyo
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4547
NA
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
| 2026 | Year | 04 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 04 | Month | 09 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070037
