UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047621 |
|---|---|
| Receipt number | R000054294 |
| Scientific Title | Study on application of smartphone cognitive behavioral therapy to promote mental health and well-being in the workplace |
| Date of disclosure of the study information | 2022/05/06 |
| Last modified on | 2024/02/20 12:40:07 |
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Basic information
Public title
Study on application of smartphone cognitive behavioral therapy to promote mental health and well-being in the workplace
Acronym
Study on application of smartphone cognitive behavioral therapy to promote mental health and well-being in the workplace
Scientific Title
Study on application of smartphone cognitive behavioral therapy to promote mental health and well-being in the workplace
Scientific Title:Acronym
Study on application of smartphone cognitive behavioral therapy to promote mental health and well-being in the workplace
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A smartphone cognitive-behavioral therapy app aimed at improving the mental health and well-being of working adults and a chatbot that encourages continued use of that app will be randomly assigned to two groups depending on the presence or absence of a chatbot for 150 Sony employees. Then, check the effect of the message by the chatbot.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint is the completion of the smartphone cognitive-behavioral therapy app, which calculates the percentage of participants who completed the problem-solving component within 8 weeks (56 days) from the day they started using the app.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Have all participants use the smartphone cognitive behavioral therapy app. The app consists of five components(self-monitoring, cognitive reconstruction, behavioral activation, assertion, problem-solving), with participants working on lessons in turn at a pace of one component per week.
Interventions/Control_2
In addition to the above interventions, Chatbots that encourage continued use of the smartphone cognitive-behavioral therapy app are randomly assigned to two groups, with and without chatbots. Chatbot users are sent daily, morning and night with messages that encourage them to use the app.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Full-time employee of Sony Group Corporation or Sony Corporation
2) Living in Japan
3) Men and women between the ages of 20 and 60
4)They must have their own smartphone, either an Apple iPhone or Android device
5)They must provide electromagnetic or written informed consent to participate in this study
6)They must agree to use the smartphone cognitive behavioral therapy app
7)They must agree to the license and use of wearable device and messaging application.
Key exclusion criteria
1)Being unable to read or write Japanese sentences
2)Receiving professional treatment for mental health problems
3)PHQ-9 score of the pre-assessment meets the following two points
i)15 points or more
ii)10 points or more and 9th item (suicidal ideation item) is 2 or 3
4)Expected to retire during the participation period (retirement age or job change has been decided)
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Kishimoto |
Organization
Sony Group Corporation
Division name
R&D Center Tokyo Laboratory 11
Zip code
113-8510
Address
Sony Open Lab., Tokyo Medical and Dental University M&D Tower 20F ,1-5-45 Yushima Bunkyo-ku, Tokyo, Japan
TEL
070-7598-7140
Takuya.Kishimoto@sony.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Kishimoto |
Organization
Sony Group Corporation
Division name
R&D Center Tokyo Laboratory 11
Zip code
113-8510
Address
Tokyo Medical and Dental University M&D Tower 20F ,1-5-45 Yushima Bunkyo-ku, Tokyo, Japan
TEL
070-7598-7140
Homepage URL
sgc-rdc-tl11-dh-epoc-office@sony.com
Sponsor or person
Institute
Sony Group Corporation
Institute
Department
Personal name
Funding Source
Organization
Sony Group Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Sony Bioethics Committee
Address
1-7-1 Kounan, Minato-ku, TOKYO, JAPAN
Tel
03-6748-2111
info-s-rec@sony.com
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
ソニーグループ株式会社 R&Dセンター Tokyo Laboratory 11
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
https://mentalhealth.bmj.com/content/ebmental/27/1/e300881/DC2/embed/inline-supplementary-material-2
Publication of results
Published
Result
URL related to results and publications
https://mentalhealth.bmj.com/content/27/1/e300881
Number of participants that the trial has enrolled
142
Results
This is an implementation study to examine the effect of an automated chatbot to improve the adherence rate of iCBT.
We analysed data from 142 participants for the primary outcome. The completion rate of the iCBT+chatbot group was 34.8% (24/69, 95% CI 23.5 to 46.0), that of the iCBT group was 19.2% (14/73, 95% CI 10.2 to 28.2), and the risk ratio was 1.81 (95% CI 1.02 to 3.21).
Results date posted
| 2024 | Year | 02 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 11 | Day |
Baseline Characteristics
The inclusion criteria for participants were as follows: (1) full-time employees of Sony Group Corporation and Sony Corporation; (2) residents of Japan; (3) aged 20 - 60 years; (4) owned a smartphone (iPhone or Android); (5) agreed to use the iCBT app; and (6) agreed to use fitbit (Fitbit), fitabase (Small Step Labs LLC, fitbit data collection service) and LINE (LINE Corporation, messaging service).
The exclusion criteria for participants were as follows: (1) inability to read and write Japanese texts; (2) undergoing follow-up and treatment by a psychiatrist or other mental health professional; (3) a total Patient Health Questionnaire-9 (PHQ-9)score at the time of application of 15 or above, or 10 - 14 with 2 or 3 on the 9th item (suicidal ideation); and (4) plan to retire (retire or change jobs to other companies) during the participation period.
We recruited participants in April 2022, screened 334 applicants and invited 149 who met the eligibility criteria to an information session. They comprised 15 employees who scored four or less and 134 participants who scored between 5 and 9 or between 10 and 14 but scored 0 or 1 on the 9th item (suicidal ideation). The 149 applicants participated in an online information session and provided electromagnetic consent after a detailed explanation by a clinical research coordinator (CRC). Participants who completed IC (Informed Consent) were asked to complete the psychoeducation for the application during the orientation session. Participants who did not complete the psychoeducation during the orientation were asked to complete the psychoeducation lesson within a specified period. We discontinued the intervention for safety reasons if participants met the following conditions: a PHQ-9 score of 15 or higher or a score of 10 - 14 with a score of 2 or 3 on its 9th item (suicidal ideation) over 3 weeks.
Participant flow
A smartphone app named "Resilience Training SE (Sony Edition)" includes six iCBT components: psychoeducation (PE), behavioural activation (BA), self-monitoring (SM), cognitive restructuring (CR), assertiveness training (AT) and problem-solving (PS). During the orientation session, all participants first received psychological training on the importance of resilience to stress, CBT and weekly self-check (PHQ-9). According to PE, the app was programmed in the order of BA, SM, CR, AT and PS, each with an approximate completion time of 1 week. Each component consisted of a PE lesson describing a cognitive or a behavioural skill and a worksheet to practise what was learnt. Participants were told that the test period would end after 8 weeks. The app opened weekly and prompted participants to answer the self-check. If a participant did not respond for several days, an automated email was sent to the participant, asking them to respond to the self-check. If a participant scored 15 or higher, or between 10 and 14 with a score of 2 or 3 on the 9th item (suicidal ideation), the administration sent an email advising them to contact psychological services such as occupational health. If the condition persisted for 3 consecutive weeks, the administration advised them to contact health services and informed them that the intervention would be discontinued. Each of the nine items constituting the PHQ-9 scores from 0 (not at all) to 3 (almost every day), with a range of 0 - 27 points. Scores of 10 - 14 are classified as moderate, 15 - 19 as moderately severe and 20 - 27 as severe. The administration sent participants a web-based questionnaire during the information session and 4 and 8 weeks afterwards to collect their responses.
Adverse events
one of the participants had been hospitalised during the study because of a traffic accident which was judged unlikely to have been caused by this study. Apart from this, none of the participants had serious adverse events.
Outcome measures
The primary outcome was the completion rate of the "Resilience Training SE." Completion rate for the app was defined as the percentage of participants who completed the lesson, which consisted of five components, to completion within 8 weeks (56 days) from the day after the end of PE. Completing the lesson to the end was defined as reading the entire lesson and completing a problem-solving component worksheet before the epilogue.
Secondary outcomes were changes from baseline to week 8 on the PHQ-9 measuring depression, Generalized Anxiety Disorder-7 (GAD-7) measuring anxiety, CBT skills, The Satisfaction with Life Scale (SWLS) measuring well-being, WHO-5 measuring well-being, Presenteeism Scale from WHO Health and Work Performance Questionnaire (Presenteeism) measuring presenteeism, Work and Social Adjustment Scale (WSAS) measuring social function, and Utrecht Work Engagement Scale (UWES) measuring work engagement.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 05 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 26 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 28 | Day |
Last modified on
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054294
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/02/20 | ebmental-2024-January-27-1--inline-supplementary-material-2.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/02/20 | ebmental-2024-January-27-1--inline-supplementary-material-1.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/02/20 | ebmental-2024-January-27-1--inline-supplementary-material-3.pdf |
