UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048563 |
|---|---|
| Receipt number | R000054621 |
| Scientific Title | Exploratory study of the effectiveness of interpersonal counseling for mental health associated with COVID-19 |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/03/17 11:01:16 |
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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 interpersonal counseling 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 study exploratory whether online-Interpersonal Counseling (o-IPC) is effective for COVID-19-related depression.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the comparison of the QIDS-J score changes from baseline to each measurement point (4 weeks, 8 weeks, 12 weeks after the intervention) between the o-IPC group and the waiting group.
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
Interpersonal Counseling(once a week, a total of 3 times)
Interventions/Control_2
Counseling with listening(once a week, a total of 3 times)
Interventions/Control_3
Waiting((waiting of 2 weeks: same as other intervention period))
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 the written consent to participate in the research.
2.Those who complain of depression related to COVID-19
3.The score of Quick Inventory of Depressive Symptomatology Japanese version (QIDS-J) is 6 points or more
4.Those who can get permission to participate in the research from the attending physician if he / she is undergoing outpatient treatment due to some illness.
Key exclusion criteria
Those who are at high risk of suicide.
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
6628501
Address
1-155 Uegahara Ichibancho, Nishinomiya-shi, Hyogo, JAPAN
TEL
0798544517
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
6628501
Address
1-155 Uegahara Ichiban-cho, Nishinomiya, Hyogo, Japan
TEL
0798544517
Homepage URL
hisaono@kwansei.ac.jp
Sponsor or person
Institute
Kwansei Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kwansei Gakuin University Committee for Regulations for Behavioral Research with Human Participants
Address
1-155 Uegahara Ichiban-cho, Nishinomiya, Hyogo, Japan
Tel
0798546104
human-ethic@kwansei.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
22K03136
Org. issuing International ID_1
Japan Society for the Promotion of Science
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | 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
| 2022 | Year | 08 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054621
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
