UMIN-CTR Clinical Trial

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
Email	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
Email	nasasaki-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044111