UMIN-CTR Clinical Trial

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
Email	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
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	Ethics Committee Tohoku University Hospital.
Address	1-1, Seiryo-machi, aoba-ku, Sendai
Tel	022-728-4105
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027463