UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040304 |
|---|---|
| Receipt number | 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 | 2023/06/07 14:01:01 |
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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
Pregnant women in the intervention group will receive a total of three sessions after 22 weeks of gestation and throughout the gestation period, according to the pamphlet. The content of the sessions will be on understanding mental health in the perinatal period, how emotions work, and how to solve problems using cognitive-behavioral therapy.
The second session will be a brainstorming session on baby crying and feeding, using illustrations to brainstorm ideas for patterns that change ideas and patterns that change behavior.
The third session will be conducted in the same way as the second session. The content of the session will be to brainstorm ideas for patterns of changing ideas and patterns of changing behavior based on the illustrations regarding human relationships during child-rearing.
Follow-up emails will be sent two weeks after the session, one week after the delivery date, two weeks after the delivery date, and three weeks after the delivery date.
Interventions/Control_2
The control group is usual care.
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
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
18dn002@slcn.ac.jp
Sponsor or person
Institute
St.Luke's International Univercity
Institute
Department
Personal name
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
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
Not officially announced
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37163508/
Number of participants that the trial has enrolled
63
Results
The change in GAD-7 scores from prenatal to one month postpartum averaged -1.77 for the intervention group and -0.97 for the control group, with a p-value of .521, with no significant difference between the two groups, although the intervention group showed a greater decrease.
In particular, primiparas showed a greater change in GAD-7 scores in the intervention group, and some expressed a desire for postpartum sessions, suggesting that additional postpartum follow-up sessions would be beneficial.
Results date posted
| 2023 | Year | 06 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean number of weeks of pregnancy at recruitment was 29 weeks for both groups.
The mean age was 32.1 years in the intervention group (SD = 3.11) and 34.1 years in the control group (SD = 4.33), with 15 (45.5%) first-time mothers in the intervention group and 14 (46.7%) in the control group.
Participant flow
A target of 60 participants was recruited, and 63 participants who met the final inclusion criteria consented to participate in the study.
Sixty-three women who met the inclusion criteria were randomly assigned to receive the program or to a control group. Sixty-three women were randomly assigned to two groups, an intervention group and a control group, with stratified block random assignment of first-time mothers and transient mothers.
Thirty-three women were assigned to the intervention group, one of whom was hospitalized for preterm labor and dropped out, and the remaining 32 women responded to a questionnaire at 1 month postpartum (97% follow-up). The control group consisted of 30 women, one of whom dropped out due to preterm labor, and the remaining 29 women responded to the 1-month postpartum questionnaire (follow-up rate: 97%). The remaining 29 women responded to the questionnaire up to 1 month postpartum (follow-up rate: 96.7%). In the end, 32 women in the intervention group and 29 women in the control group were included in the analysis.
The remaining 29 women responded to the questionnaire up to 1 month postpartum (follow-up rate: 96.7%).
Adverse events
There was no adverse event.
Outcome measures
Primary Outcome:
Change in anxiety level from pre-intervention to 1 month postpartum (GAD-7)
Secondary Outcome:
1) Change in anxiety before and after the program (GAD-7)
2) Change in depression and anxiety from pre-program to 1 month postpartum (K6)
3) Level of postpartum depression risk at 1 month postpartum (EPDS)
4) Change in self-efficacy for CBT response: A self-efficacy evaluation chart for CBT response in the perinatal period was developed independently.
5) Program satisfaction (CSQ-8J)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 04 | Day |
Last modified on
| 2023 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045983
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