UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024940
Receipt No. 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 2018/05/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Hiroo Matsuoka
Organization Tohoku University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-1, Seiryo-machi, aoba-ku, Sendai
TEL 022-717-7262
Email mtok-thk@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Saya Kikuchi
Organization Tohoku University Hospital
Division name Department of Psychiatry
Zip code
Address 1-1, Seiryo-machi, aoba-ku, Sendai
TEL 022-717-7262
Homepage URL
Email kiksaya@gmail.com

Sponsor
Institute Tohoku University Hospital
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 30 Day
Last follow-up date
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
2018 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027463

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.