UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055673 |
|---|---|
| Receipt number | R000063139 |
| Scientific Title | Evaluation of the Prevention Effectiveness of an Online CBT Program for Employees |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/07/04 10:03:37 |
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Basic information
Public title
Evaluation of the Prevention Effectiveness of an Online CBT Program for Employees
Acronym
Evaluation of the Prevention Effectiveness of an Online CBT Program for Employees
Scientific Title
Evaluation of the Prevention Effectiveness of an Online CBT Program for Employees
Scientific Title:Acronym
Evaluation of the Prevention Effectiveness of an Online CBT Program for Employees
Region
| Japan |
Condition
Condition
Well-being of workers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this pilot study is to examine the effectiveness of an online CBT (Cognitive Behavioral Therapy) program provided by Lezily Inc., aimed at workers as a preventive intervention. This research aims to improve mental health and prevent deterioration among workers by evaluating this preventive approach.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measure will be psychological well-being, assessed using the Psychological Well-Being Scale short-form (Iwano et al., 2015). Measurements will be taken at the start of the online CBT program and then at 3, 6, and 9 months after the program begins. Each measurement will be considered valid if it is conducted within a 2-week period before or after the scheduled time.
Key secondary outcomes
The following secondary outcome measures will be assessed at 0, 3, 6, and 9 months after the start of the online CBT program. The assessment period will be considered valid for a duration of two weeks before and after each assessment point. Additionally, "Program Satisfaction" and "Program Practicality" will be assessed only at 3 months after the program's start, while "Dropout" and "Safety Assessment Items" will be measured at each session.
Measures to be assessed:
Psychological distress (K6, Kessler et al., 2002)
Presenteeism (WHO-HPQ, Kessler et al., 2003)
Absence from work or resignation due to mental health reasons
Program Satisfaction
Program Practicality
Dropout
Safety Assessment Items
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Individuals who are affiliated with a company to which Lezily Inc. offers the programs and who have attended the programs
- Individuals who have agreed to participate in this study
Key exclusion criteria
- Individuals who were found to have suicidal thoughts during the program
- Individuals who do not have normal visual or auditory functions
- Individuals who are not Japanese speakers
Target sample size
77
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Fujiwara |
Organization
Lezily, Inc.
Division name
Unaffiliated
Zip code
104-0061
Address
2nd-floor Ginzaotakebijidensu 1-22-11 Ginza, Chuo-ku, Tokyo-to
TEL
03-6674-1203
y.fujiwara@lezily.com
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Fujiwara |
Organization
Lezily, Inc.
Division name
Unaffiliated
Zip code
104-0061
Address
2nd-floor Ginzaotakebijidensu 1-22-11 Ginza, Chuo-ku, Tokyo-to
TEL
03-6674-1203
Homepage URL
y.fujiwara@lezily.com
Sponsor or person
Institute
Lezily, Inc.
Institute
Department
Personal name
Funding Source
Organization
Lezily, 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
The ethics committee of Osaka University Hospital
Address
4th Floor, Center of Medical Innovation and Translational Research, 2-2 Yamadaoka, Suita City, Osaka Prefecture, Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
G24153-2
Org. issuing International ID_1
The ethics committee of Osaka University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-institution prospective observational study, so randomization is not conducted.
*Online CBT Program by Lezily Inc.*
The program is based on Behavioral Activation (BA) designed to improve mood through pleasant activities. The program is divided into two main parts: regular sessions and optional additional sessions. The additional sessions are available only to those who have completed the regular sessions and wish to continue.
Regular Sessions:
In the first session, participants are introduced to the "Lezily" service, receive some basic psychological education, and set personal goals for the program. In the second and third sessions, participants create a model to understand how they react to different events and plan pleasant activities to boost their mood. The fourth session, which is the final regular session, involves reviewing and summarizing what was done in the previous sessions to help reinforce the effects.
Additional Sessions:
The additional sessions repeat the content from the second to fourth regular sessions.
*Registration Procedure*
1. Online Information Session: An online session will be held for all participants in the online CBT program provided by Lezily, Inc., to explain the study's purpose and overview along with the service introduction. The session will use tools like Zoom, allowing participants to ask questions in real-time.
2. Consent via Web Survey: After the session, a web survey for obtaining consent will be sent to all participants.
3. Registration Completion: After confirming consent, participants will receive a document detailing the consent items, along with a notification of registration completion via email or similar methods.
Management information
Registered date
| 2024 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063139
