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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040304
Receipt No. R000045983
Scientific Title Development and Effectiveness of Program Using Cognitive Behavioral Therapy for Pregnant Women at Risk for Anxiety Disorder : A Pilot Randomized Controlled Trial
Date of disclosure of the study information 2020/07/01
Last modified on 2020/05/04

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Basic information
Public title Development and Effectiveness of Program Using Cognitive Behavioral Therapy for Pregnant Women at Risk for Anxiety Disorder : A Pilot Randomized Controlled Trial
Acronym Development and Effectiveness of Program Using Cognitive Behavioral Therapy for Pregnant Women at Risk for Anxiety Disorder : A Pilot Randomized Controlled Trial
Scientific Title Development and Effectiveness of Program Using Cognitive Behavioral Therapy for Pregnant Women at Risk for Anxiety Disorder : A Pilot Randomized Controlled Trial
Scientific Title:Acronym Development and Effectiveness of Program Using Cognitive Behavioral Therapy for Pregnant Women at Risk for Anxiety Disorder : A Pilot Randomized Controlled Trial
Region
Japan

Condition
Condition Pregnant Women at Risk for Anxiety Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to develop an intervention program utilizing cognitive behavioral therapy for pregnant women at risk of anxiety disorder, and to examine the effect size of each outcome, the appropriateness and feasibility of the intervention program, etc. in a pilot randomized controlled trial. In addition, the extent to which anxiety in the first month after childbirth is affected by the presence or absence of programs that utilize cognitive behavioral therapy, age, support status, history of pregnancy, etc. will be explored.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change in GAD-7 score is calculated as the difference between the two groups in the change in anxiety one month after delivery.
Key secondary outcomes Changes in GAD7 score before and after the program. Changes in K6 score from before the program to one month after delivery. Degree of EPDS at 1 month postpartum. Degree of self-efficacy regarding childcare one month after delivery. Changes in self-efficacy related to cognitive behavioral therapy.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 intervention:At the pregnancy checkup during the 28-33 week , the researchers will conduct the first session according to the pamphlet.
At the end of the session, the researcher will give a pamphlet with the contents of all three times to the pregnant woman. The session contents are about understanding of mental health in perinatal period, emotional mechanism, and problem solving method using cognitive behavior therapy.
The content of the secoud session is about baby crying and breastfeeding. Based on the illustrations, we will come up with ideas for changing ideas and changing behavior.
The third session will be conducted in the same way as the second session. The content of the session is human relationships during childcare.
Based on the illustrations, we will come up with ideas for changing ideas and changing behavior.
The researchers will send a follow-up email at the two weeks after the session,One week after delivery, two weeks after delivery, three weeks after delivery,
Interventions/Control_2 The control group is usual care.
Around 24-26 weeks of pregnancy, the midwife checks the childcare support checklist and collects specific information. In addition, the midwife will hand out a general anxiety disorder assessment tool GAD-2 and a two-item questionnaire regarding depression in the pregnancy checkup after 28 weeks of pregnancy to screen for the risk of anxiety disorder and perinatal depression. is doing.
In addition, midwives measure EPDS at the end of pregnancy, and if the score is 9 or higher, judge a pregnant woman with a high risk of postpartum depression. The basics of care are to share information among staff, support as recommended in the Japanese Maternal and Mental Health Care Manual, that is, to avoid prejudice and listen to the maternal story with empathy.
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

Not applicable
Gender Female
Key inclusion criteria Pregnant women after 22 weeks of pregnancy, generalized anxiety disorder assessment tool GAD-7 5 to 14 points, pregnant women who can speak and read and write in Japanese.
Key exclusion criteria Pregnant women who regularly undergo psychiatry for the diagnosis of mental illness.
Pregnant women who need bed rest or hospital treatment for the diagnosis of pregnancy complications.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Aiko
Middle name
Last name Okatsu
Organization St.Luke's International Univercity,graduate School
Division name Doctral Program in Midwifery
Zip code 104-0045
Address 3-8-5,Tsukiji,Chuo-ku,Tokyo,JAPAN
TEL 03-6226-6361
Email 18dn002@slcn.ac.jp

Public contact
Name of contact person
1st name Aiko
Middle name
Last name Okatsu
Organization St.Luke's International Univercity,graduate School
Division name Doctral Program in Midwifery
Zip code 104-0045
Address 3-8-5,Tsukiji,Chuo-ku,Tokyo,JAPAN
TEL 03-6226-6361
Homepage URL
Email 18dn002@slcn.ac.jp

Sponsor
Institute St.Luke's International Univercity
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
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 St.Luke's International Univercity
Address 10-1,Akashi-cho,Chuo-ku,Tokyo,JAPAN
Tel 03-3543-6391
Email 18dn002@slcn.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
2020 Year 07 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 15 Day
Last follow-up date
2020 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 04 Day
Last modified on
2020 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045983

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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