UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044079 |
|---|---|
| Receipt number | R000050312 |
| Scientific Title | The longitudinal observational study for mental health in women in the perinatal periods |
| Date of disclosure of the study information | 2021/04/30 |
| Last modified on | 2023/05/02 11:25:30 |
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Basic information
Public title
The longitudinal observational study for mental health in women in the perinatal periods
Acronym
The longitudinal observational study for mental health in women in the perinatal periods
Scientific Title
The longitudinal observational study for mental health in women in the perinatal periods
Scientific Title:Acronym
The longitudinal observational study for mental health in women in the perinatal periods
Region
| Japan |
Condition
Condition
Women in the perinatal periods
Classification by specialty
| Obstetrics and Gynecology | Psychiatry | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To examine mental health symptoms in the perinatal period and their relationships
2. To develop Japanese versions of the scales related to perinatal anxiety, obsession, and hypomania.
3. To examine the psychological processes that associated with perinatal mental health symptoms.
4. To identify psychological hurt and supported experience during the perinatal period.
Basic objectives2
Others
Basic objectives -Others
1. To examine mental health symptoms in the perinatal period and their relationships
2. To develop Japanese versions of the scales related to perinatal anxiety, obsession, and hypomania.
3. To examine the psychological processes that associated with perinatal mental health symptoms.
4. To identify psychological hurt and supported experience during the perinatal period.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mental health symptoms:
Cross-Cutting Symptom Measure(CCSM)
Depressive symptoms:
Edinburgh Postnatal Depression Scale(EPDS)
Patient Health Questionnaire-9(PHQ-9)
Hypomania symptoms:
Mood Disorder Questionnaire(MDQ)
Anxiety symptoms:
State-Trait Inventory for Cognitive and Somatic Anxiety(STICSA)
Brief Fear of Negative Evaluation Scale(BFNE)
Generalized Anxiety Disorder-7(GAD-7)
Penn State Worry Questionnaire(PSWQ)
Obsessive-Compulsive Inventory Revised(OCI-R)
Parental Thoughts and Behaviors Checklist(PTBC)
Primary Care PTSD Screen for DSM-5(PC-PTSD)
Posttraumatic Growth Inventory(PTGI)
Key secondary outcomes
Other Clinical indexes:
Insomnia Severity Index(ISI)
Fear of Coronaviruss-19 Scale(FCV-19S)
UCLA Loneliness Scale(R-UCLA)
Sheehan Disability Scale(SDISS)
Somatic Symptom Scale-8(SSS-8)
Violence Against Women Screen(VAWS)
Satisfaction and quality of life:
Satisfaction With Life Scale(SWLS)
Psychological processes:
Multidimensional perfectionism scale(MPS)
The Short Intolerance of Uncertainly Scale (SIUS)
Emotion Regulation Questionnaire(ERQ)
Sense of Authenticity Scale(SOA)
Mother and child, marital relations, and parenting:
Mother-to-Infant Bonding Scale(MIBS)
Parenting Sense of Competence Scale(PSOC)
The Breastfeeding Self-Efficacy Scale-Short Form(BSES-SF)
Multidimensional Scale of Perceived Social Support(MSPSS)
Marital Satisfaction Scale(MSS)
Others:
Psychological Hurt and Supported Experience
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1. Pregnant women who give consent to study participation
2. Pregnant women who have registered with an internet research company and can read and understand the research content on the explanation screen
Key exclusion criteria
None
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Ito |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
187-8551
Address
Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN
TEL
+81-42-341-2711
masaya-ito@umin.ac.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Yokoyama |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
187-8551
Address
Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN
TEL
+81-42-341-2711
Homepage URL
yokoyama-ck@umin.ac.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research(KAKENHI)of the Japan Society for the Promotion of Science
Intramural Research Grant for Neurological and Psychiatric Disorders of NCNP
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
Institutional Review Board at National Center of Neurology and Psychiatry
Address
Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN
Tel
042-341-2711
rinri-jimu@ncnp.go.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
| 2021 | Year | 04 | Month | 30 | 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
1739
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
| 2021 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Study design>
Observational study
Longitudinal study
<Method>
Registered monitors at an internet research company will be recruited, and pregnant women who have consented to participate will be surveyed at prenatal, 4 weeks postpartum, 26 weeks postpartum, and 52 weeks postpartum.
Management information
Registered date
| 2021 | Year | 04 | Month | 30 | Day |
Last modified on
| 2023 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050312
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
