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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044147
Receipt No. 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 2021/11/01

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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
Email 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
Email yuihidaka-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

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
Email 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 Open public 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
2021 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050410

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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