UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023166
Receipt number 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 2022/07/20 16:50:59

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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 Hisato
Middle name
Last name Matsunaga

Organization

Hyogo College of Medicine

Division name

Department of Neuropsychiatry

Zip code

6638501

Address

1-1 Mukogawacho Nishinomiya City Hyogo Japan

TEL

0798456051

Email

hisa1311@hyo-med.ac.jp


Public contact

Name of contact person

1st name Hitomi
Middle name
Last name Seino

Organization

Hyogo College of Medicine

Division name

Department of Neuropsychiatry

Zip code

6638501

Address

1-1 Mukogawacho Nishinomiya City Hyogo Japan

TEL

0798456051

Homepage URL


Email

seishin@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

JSPS KAKENHI Grant

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

Hyogo college of medicine

Address

1-1,Mukogawa-cho,Nishinomiya,Hyogo,Japan

Tel

+81798456051

Email

rinri@hyo-med.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 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

Completed

Date of protocol fixation

2016 Year 07 Month 15 Day

Date of IRB

2016 Year 09 Month 13 Day

Anticipated trial start date

2016 Year 09 Month 13 Day

Last follow-up date

2022 Year 09 Month 13 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 07 Month 14 Day

Last modified on

2022 Year 07 Month 20 Day



Link to view the page

Value
https://center6.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