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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041266
Receipt No. R000046962
Scientific Title Effect of internet-based attention bias modification for anxiety of Japanese worker: a randomized controlled trial.
Date of disclosure of the study information 2020/07/31
Last modified on 2020/07/31

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Basic information
Public title Effect of internet-based attention bias modification for anxiety of Japanese worker: a randomized controlled trial.
Acronym Effect of internet-based attention bias modification for anxiety of Japanese worker: a randomized controlled trial.
Scientific Title Effect of internet-based attention bias modification for anxiety of Japanese worker: a randomized controlled trial.
Scientific Title:Acronym Effect of internet-based attention bias modification for anxiety of Japanese worker: a randomized controlled trial.
Region
Japan

Condition
Condition Job stress
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the psychological effects of 1-month attention bias modification on workers in a randomized controlled trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes State-Trait Anxiety Inventory
Key secondary outcomes Utrecht Work Engagement Scale
Dutch Workaholic Scale
The Japanese version of recovery experience questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 internet-based attention bias modification
Interventions/Control_2 No treatment group
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
60 years-old >
Gender Male and Female
Key inclusion criteria Worker
Full-time worker
Working in Japan
Key exclusion criteria Person with mental illness
Person who has a heart disease
Company manager
Company executive
Foreign worker
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Tayama
Organization Nagasaki University
Division name Center for Health and Community Medicine
Zip code 852-8521
Address 1-14, Bunkyo, Nagasaki, Japan
TEL 095-819-2214
Email jtayama@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Sayaka
Middle name
Last name Ogawa
Organization Nagasaki University
Division name Center for Health and Community Medicine
Zip code 852-8521
Address 1-14, Bunkyo, Nagasaki, Japan
TEL 095-819-2214
Homepage URL
Email ogawa-sa@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 Ethics Committee of Nagasaki University Graduate School of Biomedical Sciences
Address 1-12-4, Sakamoto, Nagasaki, Japan
Tel 095-819-7195
Email gakujutu_gakuji@ml.nagasaki-u.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 31 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 300
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 No longer recruiting
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
2018 Year 08 Month 23 Day
Anticipated trial start date
2018 Year 10 Month 05 Day
Last follow-up date
2020 Year 03 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 07 Month 31 Day
Last modified on
2020 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046962

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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