UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058038 |
|---|---|
| Receipt number | R000066338 |
| Scientific Title | The effects of the self-guided iCBT app on depressive symptoms and psychological distress: a randomized controlled trial |
| Date of disclosure of the study information | 2025/06/10 |
| Last modified on | 2025/06/01 15:21:37 |
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Basic information
Public title
The effects of the iCBT app on mental health
Acronym
The effects of the iCBT app on mental health
Scientific Title
The effects of the self-guided iCBT app on depressive symptoms and psychological distress: a randomized controlled trial
Scientific Title:Acronym
The effects of the self-guided iCBT app on depressive symptoms and psychological distress: a randomized controlled trial
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effects of the self-guided iCBT app on depressive symptoms and psychological distress among workers, using a randomized controlled trial design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depressive symptoms (PHQ-9)
Psychological distress (K6)
Key secondary outcomes
Work engagement (UWES)
Work performance (HPQ)
Well-being (WHO5)
(Only intervention group)
Implementation outcome (iOSDMH)
Japanese version of the user version of the Mobile Application Rating Scale e application assessment scale (uMARS)
Complete rate of the program (System log)
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The self-guided iCBT app consists of the following six modules:
1) Psychoeducation based on the transactional model of stress and coping
2) Case-formulation based on the cognitive behavioral model
3) Behavioral activation
4) Cognitive restructuring (Part 1)
5) Cognitive restructuring (Part 2)
6) Problem-solving
Each module includes approximately 15 minutes of learning and exercises. Participants progress through the program via a chat-style interaction with an in-app character.
Interventions/Control_2
No treatment
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) Those who are more than 18 years old.
2) Individuals in full-time employment
Key exclusion criteria
N/A
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Imamura |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Digital Mental Health
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9621
kouima-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Imamura |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Digital Mental Health
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9621
Homepage URL
kouima-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
emol inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
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
| 2025 | Year | 06 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 06 | Month | 01 | Day |
Last modified on
| 2025 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066338
