UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024940 |
|---|---|
| Receipt number | R000027463 |
| Scientific Title | Effectiveness Study of Day Program in a Psychiatry Setting for Depressed or Anxious Women in Early Postpartum. |
| Date of disclosure of the study information | 2016/11/22 |
| Last modified on | 2020/05/26 10:13:40 |
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Basic information
Public title
Effectiveness Study of Day Program in a Psychiatry Setting for Depressed or Anxious Women in Early Postpartum.
Acronym
Effectiveness Study of Day Program in a Psychiatry Setting for Depressed or Anxious Women in Early Postpartum.
Scientific Title
Effectiveness Study of Day Program in a Psychiatry Setting for Depressed or Anxious Women in Early Postpartum.
Scientific Title:Acronym
Effectiveness Study of Day Program in a Psychiatry Setting for Depressed or Anxious Women in Early Postpartum.
Region
| Japan |
Condition
Condition
Depressed Disorders
Anxiety Disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of day program for depressed or anxious women in early postpartum
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depressed symptoms just after the intervention
Key secondary outcomes
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
Intervention:day program(group psychotherapy, psychoeducation, relaxation etc.)
2hour/day,once a week, total 8 times
Interventions/Control_2
Treatment as Usual: standard primary care with health visitor, midwives, clinical psychologist.standard psychiatric 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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1.Women within 6 months postpartum who can participate day program with her baby.
2.Women who gets treatment in psychiatric or obstetric department in our hospital
3.Depression suspected(EPDS>=9)
4.Depressive disorders or Anxiety disorders(DSM-5)
5.Women from 20 to 50 years old.
6.No baby's administration
7.Women has a hasband or a partner
8.Women has a consent
Key exclusion criteria
1.active suicidality
2.acute psychotic symptoms
3.When doctor-in-charge judged it is unfavorable to participate this study
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Matsuoka |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
9808574
Address
1-1, Seiryo-machi, aoba-ku, Sendai
TEL
022-717-7262
mtok-thk@umin.ac.jp
Public contact
Name of contact person
| 1st name | Saya |
| Middle name | |
| Last name | Kikuchi |
Organization
Tohoku University Hospital
Division name
Department of Psychiatry
Zip code
9808574
Address
1-1, Seiryo-machi, aoba-ku, Sendai
TEL
022-717-7262
Homepage URL
kiksaya@gmail.com
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education,Culture,Sports,Science and Technology.
Department of Psychiatry, Tohoku University Hospital
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
Ethics Committee Tohoku University Hospital.
Address
1-1, Seiryo-machi, aoba-ku, Sendai
Tel
022-728-4105
rinri-2@proj.med.tohoku.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
| 2016 | Year | 11 | Month | 22 | 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
| 2016 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 08 | 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
| 2016 | Year | 11 | Month | 22 | Day |
Last modified on
| 2020 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027463
