UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051354 |
|---|---|
| Receipt number | R000058520 |
| Scientific Title | Randomized controlled trial of a wellbeing smartphone application (Intellect app) aimed to reduce depressive symptoms in Japanese Working Adults presenting with depressive symptoms. |
| Date of disclosure of the study information | 2023/06/16 |
| Last modified on | 2024/02/19 16:27:50 |
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Basic information
Public title
Randomized controlled trial of a wellbeing smartphone application (Intellect app) aimed to reduce depressive symptoms in Japanese Working Adults presenting with depressive symptoms.
Acronym
Randomized controlled trial of a wellbeing smartphone application (Intellect app) aimed to reduce depressive symptoms in Japanese Working Adults presenting with depressive symptoms.
Scientific Title
Randomized controlled trial of a wellbeing smartphone application (Intellect app) aimed to reduce depressive symptoms in Japanese Working Adults presenting with depressive symptoms.
Scientific Title:Acronym
Randomized controlled trial of a wellbeing smartphone application (Intellect app) aimed to reduce depressive symptoms in Japanese Working Adults presenting with depressive symptoms.
Region
| Japan |
Condition
Condition
Depressive symptoms
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to evaluate whether a wellbeing smartphone application (Intellect app) aimed at reducing depressive symptoms improves depressive symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Depressive symptoms (Measured by PHQ-4) at 2-month follow-up after 1-month intervention
Key secondary outcomes
Wellbeing and Organizational Outcome (Measured by EW-OO-S)
Cognitive Behavioral Therapy Skills (Measured by CBT-SS)
Usability/Accessibility (Measured by iOSDMH)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Engage with the "Intellect" application for at least 20 mins / week, for 4 consecutive weeks.
Interventions/Control_2
assessment only
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A full-time Japanese employees wi
th mild, moderate, severe levels o
f depressive symptoms
Have given consent to participate in the study
Those who use smartphones on a daily basis
Key exclusion criteria
With suicidal thoughts
Other persons deemed inappropriate as subjects of this study by the principal investigator
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Yokomitsu |
Organization
University of Human Environments
Division name
School of Psychological Sciences
Zip code
790-0825
Address
9-12, dogo-himata, Matsuyama, Ehime 790-0825, Japan
TEL
089-926-7007
k-yokomitsu@uhe.ac.jp
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Yokomitsu |
Organization
University of Human Environments
Division name
School of Psychological Sciences
Zip code
7900825
Address
9-12, dogo-himata, Matsuyama, Ehime 790-0825, Japan
TEL
08066417784
Homepage URL
yokomitsuken5@gmail.com
Sponsor or person
Institute
University of Human Environments
Institute
Department
Personal name
Funding Source
Organization
Intellect Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Intellect Japan Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, School of Psychological Sciences, University of Human Environments
Address
9-12, dogo-himata, Matsuyama, Ehime 790-0825, Japan
Tel
089-926-7007
k-yokomitsu@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
| 2023 | Year | 06 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | 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
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 16 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058520
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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