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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000042556 |
Receipt No. | R000048548 |
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 |
Date of disclosure of the study information | 2020/12/01 |
Last modified on | 2020/11/26 |
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 |
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Condition | ||
Condition | Psychological distress, Fear about COVID-19 infection | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Adults
2) Full-time employee |
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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. |
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Target sample size | 1000 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
norito@m.u-tokyo.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |