UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Internet-delivered psychoeducation program named "Imacoco-care" on improving psychological distress among workers under COVID-19 infection
Acronym	Effect of "Imacoco-care" on psychological distress under COVID-19 infection
Scientific Title	Effect of Internet-delivered psychoeducation program named "Imacoco-care" on improving psychological distress among workers under COVID-19 infection: a randomized controlled trial
Scientific Title:Acronym	Effect of "Imacoco-care" on psychological distress under COVID-19 infection
Region	Japan

Condition
Condition	Psychological distress, Fear about COVID-19 infection
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of newly developed Internet-delivered psychoeducational program named "Imacoco-care" on improving psychological distress and fear about COVID-19 infection among workers using randomized controlled trial design.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Psychological distress (K6) Fear about COVID-19 (Fear of COVID-19 Scale)
Key secondary outcomes	Depressive symptoms (PHQ-9) Non-specific anxiety symptoms (GAD-7) Work engagement (UWES) Work performance (HPQ) Well-being (TOMH well-being 24 scale) The Japanese version of the Insomnia Severity Index (ISI-J) Basic lifestyle (smoking, drinking, exercise) Communication (the number of people directly communicated with)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Internet-delivered psychoeducational program for managing stress under spreading COVID-19 infection will be provided.
Interventions/Control_2	treatment-as-usual
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	1) Adults 2) Full-time employee
Key exclusion criteria	1) Having 15 sick leave days or more during the past 3 months. 2) Having consultations with mental health professionals during the past a months. 3) having watched this intervention program in the past.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Norito Middle name Last name Kawakami
Organization	The University of Tokyo
Division name	Department of mental health
Zip code	113-0033
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 Japan
TEL	03-5841-3521
Email	norito@m.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Kotaro Middle name Last name Imamura
Organization	The University of Tokyo
Division name	Department of mental health
Zip code	113-0033
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 Japan
TEL	03-5841-3612
Homepage URL
Email	kouima-tky@umin.ac.jp

Sponsor
Institute	Department of Mental Health, Graduate School of Medicine The University of Tokyo
Institute
Department

Funding Source
Organization	Department of Mental Health, Graduate School of Medicine The University of Tokyo
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	Office for Human Research Studies (OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
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	2020 Year 12 Month 01 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	2020 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date	2020 Year 12 Month 05 Day
Last follow-up date	2021 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 11 Month 26 Day
Last modified on	2020 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048548

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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