UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044147 |
|---|---|
| Receipt number | R000050410 |
| Scientific Title | Effects of interned-based transdiagnostic CBT preventive intervention blended with online group session on anxiety and depression among workers: randomized controlled trial |
| Date of disclosure of the study information | 2021/05/10 |
| Last modified on | 2023/07/20 04:20:48 |
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Basic information
Public title
Effects of interned-based transdiagnostic CBT preventive intervention blended with online group session on anxiety and depression among workers: randomized controlled trial
Acronym
Effects of interned-based transdiagnostic CBT preventive intervention blended with online group session on anxiety and depression among workers: randomized controlled trial
Scientific Title
Effects of interned-based transdiagnostic CBT preventive intervention blended with online group session on anxiety and depression among workers: randomized controlled trial
Scientific Title:Acronym
Effects of interned-based transdiagnostic CBT preventive intervention blended with online group session on anxiety and depression among workers: randomized controlled trial
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a preventive intervention consisting of e-learning and group sessions using transdiagnostic cognitive behavioral therapy on reducing anxiety and depressive symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depressive symptom (BDI-II)
Anxiety symptoms (GAD-7)
Key secondary outcomes
Psychological distress (K6)
Quality of life (EQ-5D-5L)
Work engagement (UWES)
Job performance (HPQ)
Depression and anxiety (DASS-21)
Social anxiety symptoms (LSAS)
Before randomization, 3- and 6-month post intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
<Intervention group>
Transdiagnostic cognitive behavioral therapy will be used. Subjects will learn cognitive behavioral techniques through a total of four online group-based workshop and six e-learning modules.
After taking the online workshop once, they will take two modules of the e-learning, making it a three-month program in total.
Interventions/Control_2
<control group>
nothing will be provided
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
Male and Female
Key inclusion criteria
Must be a worker who is at least 20 years old
Key exclusion criteria
Those who have been diagnosed with depression, generalized anxiety disorder, social anxiety disorder, or panic disorder within the past six months.
Those who have been diagnosed with bipolar disorder in the past.
Those who have been absent from work for 15 days or more within 3 months due to mental symptoms.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yui |
| Middle name | |
| Last name | Hidaka |
Organization
The University of Tokyo
Division name
Department of mental health
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo, Tokyo
TEL
03-5841-3364
yuihidaka-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yui |
| Middle name | |
| Last name | Hidaka |
Organization
The University of Tokyo
Division name
Department of mental health
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo, Tokyo
TEL
03-5841-3364
Homepage URL
yuihidaka-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
Health Science Center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo, Tokyo
Tel
03-5841-0818
ethics@m.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
| 2021 | Year | 05 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050410
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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