UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041266 |
|---|---|
| Receipt number | 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 | 2021/05/19 17:13:26 |
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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
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
ogawa-sa@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
https://onlinelibrary.wiley.com/doi/full/10.1002/1348-9585.12229
Publication of results
Unpublished
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/1348-9585.12229
Number of participants that the trial has enrolled
300
Results
There was no significant difference in the net change in STAI scores between the intervention and control groups. The mean reaction time of the fifth session was significantly shorter than the mean reaction time of the first session. Furthermore, although there was no effect on the index of effect size (delta), the paired t-test showed a significant decrease in the anxiety score.
Results date posted
| 2021 | Year | 05 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
general workers
Participant flow
In total, 300 eligible participants were randomized according to sex and age; 180 were assigned to the intervention group and 120 to the control group.
Adverse events
Not applicable
Outcome measures
state anxiety
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046962
