UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054078 |
|---|---|
| Receipt number | R000061286 |
| Scientific Title | Development of Cognitive Behavioral Therapy based midwifery Care Program for Perinatal Depression and Anxiety in Preterm High-risk Pregnant Women. |
| Date of disclosure of the study information | 2024/04/07 |
| Last modified on | 2024/10/07 16:58:16 |
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Basic information
Public title
Development of Cognitive Behavioral Therapy based midwifery Care Program for Perinatal Depression and Anxiety in Preterm High-risk Pregnant Women.
Acronym
Development of Cognitive Behavioral Therapy based midwifery Care Program for Perinatal Depression and Anxiety in Preterm High-risk Pregnant Women.
Scientific Title
Development of Cognitive Behavioral Therapy based midwifery Care Program for Perinatal Depression and Anxiety in Preterm High-risk Pregnant Women.
Scientific Title:Acronym
Development of Cognitive Behavioral Therapy based midwifery Care Program for Perinatal Depression and Anxiety in Preterm High-risk Pregnant Women.
Region
| Japan |
Condition
Condition
High-risk Pregnant Women Diagnosed with Threatened Premature Labor, Cervical Incompetency, Premature Rupture of the Membranes, Placenta Previa, Hypertensive Disorders of Pregnancy and Fetal Growth Restriction
Classification by specialty
| Obstetrics and Gynecology | Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A program of midwifery care, based on cognitive behavioral therapy, has been developed to address depression and anxiety in preterm high-risk pregnant women. The program will be examined in a future RCT to determine its effectiveness. The study aims to pre-test the program and evaluate its content validity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in STAI (State-Trait Anxiety Inventory) scores before and after the program intervention is calculated for each case.
Key secondary outcomes
Changes in the EPDS (Edinburgh Postnatal Depression Scale), PHQ-9 (Patient Health Questionnaire-9), GAD-7 (Generalized Anxiety Disorder-7), MIBS-J (Mother to Infant Bonding Scale-Japanese version) and EQ-5D-5L (EuroQol-5dimension-5level) before and after the program. Post-program impressions.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The program is based on standard midwifery care from admission to the one-month postpartum check-up. It consists of six 30-minute interventions, including a cognitive-behavioral therapy component.The initial session provides psychoeducation on perinatal depression and anxiety and promotes self-understanding. This includes raising awareness of one's thinking habits and identifying whether one has fallen into a vicious cycle of thinking, using the cognitive-behavioral model. The second session aims to capture cognitions that are strongly associated with emotions, such as anxiety about preterm birth, in order to modify cognitive biases and prepare the mind for the possibility of preterm birth. The third intervention aims to transform the cognitive experience of premature birth into a positive one. This is based on the fact that the treatment resulted in the continuation of the pregnancy. The fourth session suggests integrating NICU visits and childcare behaviors into daily life as enjoyable activities. The objective of the fifth session is to facilitate behavioral change by collaboratively addressing post-discharge difficulties and problems through problem-solving techniques. The sixth session reflects on the cognitive-behavioral therapy techniques used thus far and shares what can be applied to childcare after the one-month check-up.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
This study includes only singleton pregnancies. Upon admission, the pregnant woman must be between 24 and 35 weeks' gestation. Additionally, fetal well-being has been confirmed.Symptoms have been stabilized with post-hospitalization treatment and the pregnancy is expected to continue for at least one week after admission.
Key exclusion criteria
Pregnant women with psychiatric complications, multiple gestations, fetal diseases, or who are unable to communicate in Japanese.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Tanii |
Organization
Tokyo Women's Medical University Yachiyo Medical Center
Division name
Nursing Department
Zip code
276-8524
Address
477-96 Owada Shinden, Yachiyo City, Chiba Prefecture
TEL
047-450-6000
tanii.chie@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Tanii |
Organization
Tokyo Women's Medical University Yachiyo Medical Center
Division name
Nursing Department
Zip code
276-8524
Address
477-96 Owada Shinden, Yachiyo City, Chiba Prefecture
TEL
047-450-6000
Homepage URL
tanii.chie@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Tokyo Women's Medical University
Address
8-1, Kawatachou,Shinjuku-ku,Tokyo
Tel
03-3353-8111
tanii.chie@twmu.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
| 2024 | Year | 04 | Month | 07 | 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
3
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
| 2024 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 09 | 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
| 2024 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061286
