UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047495 |
|---|---|
| Receipt number | R000054165 |
| Scientific Title | Effects of Metacognitive Training for Depression on the Prevention of Depression in College Students |
| Date of disclosure of the study information | 2022/04/18 |
| Last modified on | 2023/04/17 10:02:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Metacognitive Training for Depression on the Prevention of Depression in College Students
Acronym
Effects of D-MCT on the Prevention of Depression in College Students
Scientific Title
Effects of Metacognitive Training for Depression on the Prevention of Depression in College Students
Scientific Title:Acronym
Effects of D-MCT on the Prevention of Depression in College Students
Region
| Japan |
Condition
Condition
College students
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of D-MCT on preventing depression in college students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Patient Health Quetionnaire 9
Before and after the intervention and 1weeks after the end of the intervention
Key secondary outcomes
Metacognitions Questionnaire
Automatic thought questionnaire revised
Self esteem scale
Before and after the intervention and 1weeks after the end of the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
D-MCT will be conducted once a week for a total of 7 sessions.
Interventions/Control_2
Waiting-list
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) College students over 18 years old.
2) Those who have agreed to participate in the study.
Key exclusion criteria
1) Those who do not agreed to participate in the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Takeda |
Organization
The University of Human Environments
Division name
Department of Psychological Sciences
Zip code
790-0005
Address
9-12,Himata,Dogo,Matsuyama,Ehime
TEL
089-926-7007
t-takeda@uhe.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Takeda |
Organization
The University of Human Environments
Division name
Department of Psychological Sciences
Zip code
790-0005
Address
9-12,Himata,Dogo,Matsuyama,Ehime
TEL
089-926-7007
Homepage URL
t-takeda@uhe.ac.jp
Sponsor or person
Institute
The University of Human Environments
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Human Environments
Address
6-2, Kamisanbonmatsu, Motojyukutyo, Okazaki-shi, Aichi
Tel
0564-48-7811
t-takeda@uhe.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
| 2022 | Year | 04 | Month | 18 | 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
175
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to the addition of the test.
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 15 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054165
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
