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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023166
Receipt No. R000026642
Scientific Title Controlled Clinical Trial of Interpersonal Psychotherapy Versus Psychoeducation Program for Pregnant Women with Psychiatric Disorders during Perinatal Period
Date of disclosure of the study information 2016/07/15
Last modified on 2016/07/14

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Basic information
Public title Controlled Clinical Trial of Interpersonal Psychotherapy Versus Psychoeducation Program for Pregnant Women with Psychiatric Disorders during Perinatal Period
Acronym Controlled Clinical Trial of Interpersonal Psychotherapy Versus Psychoeducation Program for Pregnant Women with Psychiatric Disorders during Perinatal Period
Scientific Title Controlled Clinical Trial of Interpersonal Psychotherapy Versus Psychoeducation Program for Pregnant Women with Psychiatric Disorders during Perinatal Period
Scientific Title:Acronym Controlled Clinical Trial of Interpersonal Psychotherapy Versus Psychoeducation Program for Pregnant Women with Psychiatric Disorders during Perinatal Period
Region
Japan

Condition
Condition psychiatric disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of this study were to determine the efficacy of interpersonal psychotherapy versus psychoeducation program for pregnant women with psychiatric disorders.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We conducted outcome measures, including Hamilton Depression Rating Scale, Primary Care Evaluation of Mental Disorders Patient Health Questionaire, Hospital Anxiety and Depression Scale, Zungs Self-rating Depression Scale, Edinburgh Postnatal Depression Scale, Montgomery-Asberg Depression Rating Scale, and Global Assessment of Functioning at pre-and post-intervention during the perinatal period and at 1month after delivery.
Key secondary outcomes obstetrical complications
fetus and neonatal complications

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 interpersonal psychotherapy,45min,16times
Interventions/Control_2 psychoeducation,45min,16times
Interventions/Control_3 standerd therapy
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
100 years-old >=
Gender Female
Key inclusion criteria Pregnant women with psychiatric disorders
Key exclusion criteria Patients were acute risks for suicide, or had medical conditions likely to interfere with participation in the study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisato Matsunaga
Organization Hyogo College of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 1-1 Mukogawacho Nishinomiya City Hyogo Japan
TEL 0798456051
Email hisa1311@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitomi Seino
Organization Hyogo College of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 1-1 Mukogawacho Nishinomiya City Hyogo Japan
TEL 0798456051
Homepage URL
Email seishin@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization None
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
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 07 Month 15 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 Enrolling by invitation
Date of protocol fixation
2016 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 15 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 07 Month 14 Day
Last modified on
2016 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026642

Research Plan
Registered date File name
2017/07/19 研究計画書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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