UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050620
Receipt number R000057657
Scientific Title Exploratory study of the effectiveness of interpersonal counseling for mental health associated with COVID-19
Date of disclosure of the study information 2023/04/01
Last modified on 2023/03/17 14:43:35

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Basic information

Public title

Study of the effect of interpersonal counseling on "COVID-19 depression"

Acronym

Study of the effect of IPC on "COVID-19 depression"

Scientific Title

Exploratory study of the effectiveness of interpersonal counseling for mental health associated with COVID-19

Scientific Title:Acronym

Exploratory study of the effectiveness of IPC for mental health associated with COVID-19

Region

Japan


Condition

Condition

depression

Classification by specialty

Psychiatry Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The primary objective is to demonstrate the efficacy of interactive online interpersonal counseling (o-IPC) for COVID-19-related depression, including sequelae, in a quasi-randomised controlled trial.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

Comparison of changes in PHQ-9 score from baseline to each measurement point (4 weeks, 8 weeks, 12 weeks after counseling) between o-IPC and waiting groups

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Interpersonl Counseling(once a week, atotal of 3 times)

Interventions/Control_2

Waiting (2 weeks)

Interventions/Control_3

Counseling with listening(once a week, a total of 3 times)

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

18 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Those who understand the purpose of the research and can obtain written consent to participate in the research
(2) Those who are 18 years old or older at the time of study participation
(3) Those who complaining of depression related to COVID-19 and its sequelae
(4) Those who are depressed (Those who have scored 6 points or more in QIDS-J)
(5) Those who can obtain permission to participate in research from their attending physician if they are undergoing outpatient treatment for some disease

Key exclusion criteria

(1) Persons at high risk of suicide*

* Those who fall under "moderate" and "high" in the M.I.N.I. "suicide risk" item.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Hisae
Middle name
Last name Ono

Organization

Kwansei Gakuin University

Division name

Department of Integrated Psychological Sciences, School of Humanities

Zip code

662-8501

Address

1-155 Uegahara Ichibancho, Nishinomiya, Hyogo

TEL

0798544517

Email

hisaono@kwansei.ac.jp


Public contact

Name of contact person

1st name Hisae
Middle name
Last name Ono

Organization

Kwansei Gakuin University

Division name

Department of Integrated Psychological Sciences, School of Humanities

Zip code

662-8501

Address

1-155 Uegahara Ichibancho, Nishinomiya, Hyogo

TEL

0798544517

Homepage URL


Email

hisaono@kwansei.ac.jp


Sponsor or person

Institute

Kwansei Gakuin University

Institute

Department

Personal name



Funding Source

Organization

Others

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

Ethics Committee for Life Science and Medical Research Involving Human Subjects

Address

Gakuen Uegahara 1 ban Sanda, Hyogo

Tel

0795659052

Email

med-ethic@kwansei.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

2023 Year 04 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

Open public recruiting

Date of protocol fixation

2023 Year 03 Month 17 Day

Date of IRB

2023 Year 03 Month 17 Day

Anticipated trial start date

2023 Year 03 Month 17 Day

Last follow-up date

2026 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

2023 Year 03 Month 17 Day

Last modified on

2023 Year 03 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057657


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name