UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057037 |
|---|---|
| Receipt number | R000065190 |
| Scientific Title | The effectiveness of web-based psychological education using a cognitive behavioral change approach for workers with anxiety problems: a randomized controlled study |
| Date of disclosure of the study information | 2025/02/14 |
| Last modified on | 2025/02/14 16:59:47 |
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Basic information
Public title
The effectiveness of web-based psychological education using a cognitive behavioral change approach for workers with anxiety problems: a randomized controlled study
Acronym
The effectiveness of web-based psychological education using a cognitive behavioral change approach for workers with anxiety problems: a randomized controlled study
Scientific Title
The effectiveness of web-based psychological education using a cognitive behavioral change approach for workers with anxiety problems: a randomized controlled study
Scientific Title:Acronym
The effectiveness of web-based psychological education using a cognitive behavioral change approach for workers with anxiety problems: a randomized controlled study
Region
| Japan |
Condition
Condition
Anxiety
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effectiveness of web-based psychological education using cognitive behavioral change approaches that can be undertaken by individuals themselves for workers who have anxiety problems but are basically healthy, have not visited a medical institution, and have not been diagnosed with a mental disorder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Penn State Worry Ques-tionnaire(PSWQ)
Key secondary outcomes
Patient Health Questionnaire-9(PHQ-9)
Generalized Anxiety Disorder-7(GAD-7)
World Health Organization Health and Work Performance Questionnaire(WHO-HPQ9
Minimally Important Difference(MID)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Cognitive behavioral therapy
Interventions/Control_2
Time and weather records
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Those aged between 18 and 65
2)Those working at least 20 hours per week
3)Those with symptoms of anxiety that have persisted for two weeks at two-week intervals with a score of 8 or more (Mildillness or higher) on the GAD-7 (Generalized Anxiety Disorder Scale)
(The GAD-7 is assessed twice, with a two-week gap between the first and second assessments, and a score of 8 or more on the GAD-7 is recorded for both assessments)
4)Those who have never visited a psychiatric clinic, psychosomatic clinic, or mental health clinic, and have never been diagnosed with a mental disorder
5)Those who have access to the internet (either a computer, smartphone, or tablet)
6)Those whose native language is Japanese, who can understand explanations in Japanese, and who can give their own free consent online
Key exclusion criteria
1) Those who are currently being treated for a physical or mental illness at a medical institution (including psychiatric, psychosomatic, or mental health clinics)
2) Those who were indicated as requiring a detailed examination or treatment in their most recent health checkup (however, this does not exclude those who were indicated as having no abnormalities, mild abnormalities, or requiring a re-examination or lifestyle improvement)
3) Those who were indicated as being in a high-stress state in their most recent stress checkup, or those who feel that they are in a high-stress state at their current workplace
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University
Division name
Graduate School of Medicine Cognitive Behavioral Physiology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2027
neurophys1@ML.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Seki |
Organization
Chiba University
Division name
Research Center for Child Development
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2975
Homepage URL
chibarccmd@ML.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Research Institute of Economy, Trade and Industry
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
Chiba University Graduate School of Medicine School of Medicine
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-222-7171
inohana-kyodo@chiba-u.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
| 2025 | Year | 02 | Month | 14 | 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
| 2024 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065190
