UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039918 |
|---|---|
| Receipt number | R000044111 |
| Scientific Title | Effects of an internet-based acceptance and commitment therapy (iACT) intervention for improving psychological well-being among working mothers with pre-school child in Japan:a randomized controlled trial |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2021/03/25 16:57:13 |
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Basic information
Public title
Effects of an internet-based acceptance and commitment therapy (iACT) intervention for improving psychological well-being among working mothers with pre-school child in Japan:a randomized controlled trial
Acronym
Effects of an internet-based acceptance and commitment therapy (iACT) intervention for improving psychological well-being among working mothers with pre-school child in Japan:a randomized controlled trial
Scientific Title
Effects of an internet-based acceptance and commitment therapy (iACT) intervention for improving psychological well-being among working mothers with pre-school child in Japan:a randomized controlled trial
Scientific Title:Acronym
Effects of an internet-based acceptance and commitment therapy (iACT) intervention for improving psychological well-being among working mothers with pre-school child in Japan:a randomized controlled trial
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to examine the effectiveness of a new developed internet based acceptance and commitment therapy program on improving psychological well-being, as primary outcomes, among working mothers with pre-school child in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological well-being [PWBS-J](42 items)
Key secondary outcomes
Psychological distress (assessed by using the [K6])
Parental burnout (assessed by using the Parental Burnout Assessment [PBA-J])
Work engagement (assessed by using the Utrecht Work Engagement Scale [UWES])
Intention to leave their organization during the last month
Job performance (assessed by using the WHO Health and Productivity Questionnaire[HPQ])
Sick leave days in the past 3 months
Job and life satisfaction (assessed by using the Brief Job Stress Questionnaire [BJSQ])
Positive Affect Adjective (assessed by using The Positive and Negative Affect Schedule [PANAS] and affect-related items from Mroczek,1998)
Social Support
Global fear of COVID-19
Euthymia scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
This study's iACT program is a 8-module web-based program that provides stress management skills based on ACT in selp-help workbook style. The iACT program is comprised 8 modules, each covering a different component of ACT: introduction and psychological well-being (in module 1), acceptance and willingness (in module 2), defusion (in module 3), mindfullness and self-compassion (in module 4), self-as-context (in module 5), values (in module 6), committed actions (in module 7) and wrap up (in module 8).
Interventions/Control_2
Wait list control condition
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
1)Having a child in pre-school age (0-6 years old)
2)Currently employed for over 30 hours per week
3)Age over 20 years old
4)Can have an access for web site
Key exclusion criteria
Currently in maternity or childbirth leave
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Norito |
| Middle name | |
| Last name | Kawakami |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3364
nkawakami@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Natsu |
| Middle name | |
| Last name | Sasaki |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3364
Homepage URL
nasasaki-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Department of Mental Health/ Psychiatric Nursing, Graduate School of Medicine, University of Tokyo
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
Department of Mental Health, Graduate School of Medicine, The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-3364
nasasaki-tky@umin.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 | 04 | 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
842
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
The data from this trial will be made available upon reasonable request.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | 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 | 03 | Month | 24 | Day |
Last modified on
| 2021 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044111
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
