UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038847 |
|---|---|
| Receipt number | R000044263 |
| Scientific Title | Development of the psycho-education program of postnatal depressive symptoms and behavioral activation |
| Date of disclosure of the study information | 2019/12/11 |
| Last modified on | 2020/12/10 10:19:57 |
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Basic information
Public title
Development of the psycho-education program of postnatal depressive symptoms and behavioral activation
Acronym
Behavioral activation for the prevention of postnatal depression
Scientific Title
Development of the psycho-education program of postnatal depressive symptoms and behavioral activation
Scientific Title:Acronym
Behavioral activation for the prevention of postnatal depression
Region
| Japan |
Condition
Condition
Depression,Postnatal Depression
Classification by specialty
| Obstetrics and Gynecology | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We carry out the behavioral activation psychological program using SNS for the women within one year after giving birth, and examine the effect of it.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Edinburgh Postnatal Depression Scale(Japanese Version; EPDS)
Key secondary outcomes
Behavioral Activation for Depression Scale
Environmental Reward Observation Scale
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
We conduct a 7-day psycho-education program for behavioral activation using SNS.
Interventions/Control_2
No treatment
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
(a)An adult woman who is within one year after giving birth,
(b)Informed consent.
Key exclusion criteria
(a) If there is a physical problem with the fetus or the person during this pregnancy, (b) If they have experienced miscarriage or stillbirth, (c)If they have a history of mental illness, (d) if they have experienced of family or friendship death, illness or accident during this pregnancy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Miki |
| Middle name | |
| Last name | Matsunaga |
Organization
Rikkyo University
Division name
Department of Psychology
Zip code
3528558
Address
1-2-26 Kitano, Niiza-shi, Saitama 352-8558, Japan
TEL
048-471-6901
mikim@rikkyo.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Matsunaga |
Organization
Rikkyo University
Division name
Department of Psychology
Zip code
3528558
Address
1-2-26 Kitano, Niiza-shi, Saitama 352-8558, Japan
TEL
048-471-6901
Homepage URL
mikim@rikkyo.ac.jp
Sponsor or person
Institute
Rikkyo University
Institute
Department
Personal name
Funding Source
Organization
Rikkyo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rikkyo University
Address
3-34-1, NishiIkebukuro, Toshima, Tokyo
Tel
03-3985-4589
lifescience@rikkyo.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
愛和病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | 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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 12 | Month | 11 | Day |
Last modified on
| 2020 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044263
