UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056014 |
|---|---|
| Receipt number | R000064014 |
| Scientific Title | A randomized controlled study to evaluate the acceptability of a mental health care app for pregnant women and its effectiveness in improving depressive symptoms (Protocol No:NBP-24-01) |
| Date of disclosure of the study information | 2024/11/11 |
| Last modified on | 2024/12/06 15:11:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A clinical study : Mental Health Care Application for Pregnant Women (Protocol No:NBP-24-01)
Acronym
NBP-24-01
Scientific Title
A randomized controlled study to evaluate the acceptability of a mental health care app for pregnant women and its effectiveness in improving depressive symptoms (Protocol No:NBP-24-01)
Scientific Title:Acronym
NBP-24-01
Region
| Japan |
Condition
Condition
First-time pregnant women aged 18 years or older and under 40 years old
Classification by specialty
| Obstetrics and Gynecology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the acceptability of a healthcare app developed based on IPT for the purpose of providing mental healthcare for pregnant and postpartum women during their first pregnancy between 16 and 28 weeks and 6 days, and to examine its usefulness in improving depressive symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of subjects with moderate to high satisfaction (CSQ-8J score is 17 or more) at Visit 5
Change in PHQ-9 score from baseline at Visit 5
Key secondary outcomes
Percentage of subjects showing medium to high satisfaction level (CSQ-8J score is 17 or more) at Visit 6
Change in CSQ-8 score at Visit 6 from Visit 5
Change in PHQ-9 score from baseline at Visit 2, Visit 3, Visit 4, Visit 5, and Visit 6
Amount of change in EPDS score from baseline at Visit 5 and Visit 6
Change in ECR-RS score from baseline at Visit 5 and Visit 6
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
In this study, subjects in the app usage group are instructed to install the app on their own smartphones in accordance with the app installation support manual, and to use the app for approximately 5 to 10 minutes per day for approximately 57 days.
Interventions/Control_2
In this study, only the questionnaire survey will be administered to the subjects in the control 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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1. Able to electronically obtain voluntary consent to participate in the study from the individual.
2. A primiparous woman aged 18 years or older and under 40 years old at the time of obtaining consent.
3. Between 16 and 28 weeks and 6 days pregnant at the time of obtaining consent.
4. Have a partner or spouse, including a common-law marriage.
5. Have basic reading and writing skills in Japanese and can use the app and answer questionnaires without any problems.
Key exclusion criteria
1. Currently receiving treatment at a psychiatric or psychosomatic clinic (regardless of past medical history)
2. Pre-screening PHQ-9 score of 2 or more on item 9 of the PHQ-9 questionnaire indicates suicidal ideation
3. Not having a partner or spouse, or pregnant with someone other than a partner or spouse
4. Other cases where a medical advisor has determined that participation in this study is inappropriate based on concomitant medications or medical findings
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Gaku |
| Middle name | |
| Last name | Sakaguchi |
Organization
Shionogi & Co., Ltd.
Division name
New Business Promotion Department
Zip code
541-0045
Address
3-1-8, Doshomachi, Osaka Shi Chuo Ku, Osaka Fu, 541-0045, Japan
TEL
08024588057
gaku.sakaguchi@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Machitani |
Organization
Integrity Healthcare Co., Ltd.
Division name
Digital Therapy Business Department
Zip code
103-0014
Address
Yamato Bld.1kai, 1-27-5, Nihombashikakigaracho, Chuo Ku, Tokyo To, 103-0014, Japan
TEL
0366610858
Homepage URL
admin_studyformaternity@integrity-healthcare.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asai Dermatology Institutional Review Board
Address
1-14, Katabiracho, Hodogaya Ku, Yokohama Shi, Kanagawa Ken, 240-0013, Japan
Tel
045-334-3412
jimukyoku@smo-msr.co.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 | 11 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 09 | 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
| 2024 | Year | 11 | Month | 01 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064014
