UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043822 |
|---|---|
| Receipt number | R000050016 |
| Scientific Title | A randomized controlled trial of brief interpersonal psychotherapy for Japanese women with perinatal depression. |
| Date of disclosure of the study information | 2021/04/05 |
| Last modified on | 2025/10/15 14:54:19 |
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Basic information
Public title
A randomized controlled trial of brief interpersonal psychotherapy for Japanese women with perinatal depression.
Acronym
A randomized controlled trial of brief interpersonal psychotherapy for Japanese women with perinatal depression.
Scientific Title
A randomized controlled trial of brief interpersonal psychotherapy for Japanese women with perinatal depression.
Scientific Title:Acronym
A randomized controlled trial of brief interpersonal psychotherapy for Japanese women with perinatal depression.
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate an effectiveness of brief interpersonal psychotherapy for Japanese women with perinatal depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Edinburgh Postnatal Depression Scale
Key secondary outcomes
Patient Health Questionnaire-9,Hospital Anxiety and Depression Scale, Self-rating Depression Scale, Rate of Depression diagnosis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Brief Interpersonal Psychotherapy
Interventions/Control_2
Treatment as usual
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Perinatal women who met criteria for current major depressive disorder on the Structured Clinical Interview for DSM-5 disorders, Research Version.
Key exclusion criteria
Disturbance of consciousness
Diagnosis of schizophrenia or bipolar disorder
Psychotic symptoms
Substance abuse or dependence within the preceding six months
Actively suicidal ideation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Seino |
Organization
Hyogo College of Medicine
Division name
Department of Neuropsychiatry
Zip code
6638501
Address
1-1 Mukogawa-cho Nishinomiya city Hyogo, Japan
TEL
0798456051
hitomi-s@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Seino |
Organization
Hyogo College of Medicine
Division name
Department of Neuropsychiatry
Zip code
6638501
Address
1-1 Mukogawa-cho Nishinomiya city Hyogo, Japan
TEL
0798456051
Homepage URL
hitomi-s@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College of Medicine
Address
1-1 Mukogawa-cho Nishinomiya city Hyogo, Japan
Tel
0798456066
rinri@hyo-med.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
| 2021 | Year | 04 | Month | 05 | 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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2027 | 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
| 2021 | Year | 04 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050016
