UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051796 |
|---|---|
| Receipt number | R000059110 |
| Scientific Title | A randomized controlled trial of the effect of mindfulness-based intervention using a self-help app among working women |
| Date of disclosure of the study information | 2023/08/03 |
| Last modified on | 2023/08/02 17:55:45 |
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Basic information
Public title
A study of mindfulness-based intervention using a self-help app among working women
Acronym
A study of mindfulness-based intervention using a self-help app among working women
Scientific Title
A randomized controlled trial of the effect of mindfulness-based intervention using a self-help app among working women
Scientific Title:Acronym
A randomized controlled trial of the effect of mindfulness-based intervention using a self-help app among working women
Region
| Japan |
Condition
Condition
Healthy Adult Population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a mindfulness-based intervention using a self-help app for mental health, work-related outcomes and parenting-related outcomes among working women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological distress(K6)
Job performance(HPQ)
Work-life balance(SWING)
Key secondary outcomes
Somatic symptom(SSS-8)
Mindful parenting(IM-P)
Mindfulness(MAAS)
Self-compassion(SCS-SF)
Job Stress(Brief Job Stress Questionnaire)
Perceived stress(PSS)
Well-being(SWLS)
Emotion Regulation(CERQ)
Trait anger(STAXI-2)
Psychological Safety(PSS)
Creativity(self-perceived creativity)
Symptoms of Premenstrual Syndrome (DRSP)
Help seeking(ATSPPH-SF)
Insomnia severity(ISI)
Marital relationship satisfaction
Pediatric symptom(PSC)
Affect(PANAS, Affect Grid)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
<Intervention group>
Participants will perform mindfulness-based meditation with guided audio on an app. The intervention groups will perform two-weeks of breath meditation, two-weeks of body scan, two-weeks of breath-sound-body meditation, and two-weeks of compassion meditation.
Interventions/Control_2
<Control group>
nothing will be provided for waiting-list controls.
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
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Workers who work more than 20 hours per week
(2) Biologically female
Key exclusion criteria
(1) On administrative leave
(2) Receiving treatment for mental health disorders
(3) Pregnant
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ryu |
| Middle name | |
| Last name | Takizawa |
Organization
Graduate School of Education, The University of Tokyo
Division name
Department of Clinical Psychology
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3904
takizawar-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ryu |
| Middle name | |
| Last name | Takizawa |
Organization
Graduate School of Education, The University of Tokyo
Division name
Department of Clinical Psychology
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3904
Homepage URL
takizawar-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Life Science Research Ethics and Safety of The University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0620
kenkyu-kihan.adm@gs.mail.u-tokyo.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
| 2023 | Year | 08 | Month | 03 | 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
| 2023 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 05 | 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
| 2023 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059110
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| Registered date | File name |
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| Registered date | File name |
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