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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044079
Receipt No. 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 2021/04/30

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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
Obsterics 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
Email 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
Email yokoyama-ck@umin.ac.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

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
Email 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
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
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
2021 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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