UMIN-CTR Clinical Trial

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

Psychological distress, Fear about COVID-19 infection

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

12

Month

01

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048548

Publication of results

Published

URL related to results and publications

https://formative.jmir.org/2022/3/e33883/

Number of participants that the trial has enrolled

1200

Results

The Imacoco Care intervention group showed a significant favorable effect on K6 scores (P=.03) with a small effect size (ES; Cohen d=-0.14) at 3-month follow-up. In the per protocol analysis (including only participants who had read the Imacoco Care content at least 1 time), the Imacoco Care intervention group also showed a significant favorable effect on reducing K6 scores (P=.03) at 3-month follow-up.

Results date posted

2022

Year

05

Month

30

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

In the whole sample, most participants were male, were married, received university or higher education, and did not report having chronic diseases. Only less than 30% were using telecommuting. About 192 (32%) participants in each group had psychological distress (ie, scored 5 or more on K6).

Participant flow

Recruitment and the baseline survey were conducted in December 2020. Follow-up surveys in both groups were conducted 1 month (January 2021) and 3 months (March 2021) after the baseline survey. Participants who had fulfilled the inclusion criteria (ie, aged over 20 years and full-time employed) were recruited from monitors of an internet survey company (N=9484). Of those, 1367 (14.41%) were excluded according to the exclusion criteria. Of the 8117 eligible participants, 1200 (14.75%) who completed the baseline survey were selected on a first-come-first-served basis. Participants were randomly allocated to an intervention or a control group, with 600 (50%) participants in each. At 1-month follow-up, 545 (90.8%) participants in the intervention group and 575 (95.8%) in the control group completed the follow-up survey. At the 3-month follow-up, 554(92.3%) participants in the intervention group and 539 (89.8%) in the control group completed the follow-up survey.

Adverse events

In the ITT analysis, The Imacoco Care intervention group showed an adverse effect on FCV-19S scores (P=.01) with a small ES (Cohen d=0.16) at 3-month follow-up. In the per protocol analysis (including only participants who had read the Imacoco Care content at least 1 time), an adverse effect on FCV-19S scores was not significant (P=.06) in the intervention group at 3-month follow-up.

Outcome measures

Psychological distress (K6)
Fear about COVID-19 (Fear of COVID-19 Scale)

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

11

Month

30

Day

Date of IRB

2020

Year

09

Month

16

Day

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 related information

Registered date

2020

Year

11

Month

26

Day

Last modified on

2022

Year

05

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048548