UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051900 |
|---|---|
| Receipt number | R000059123 |
| Scientific Title | Feasibility of smartphone-based cognitive behavioral therapy for employees |
| Date of disclosure of the study information | 2023/08/22 |
| Last modified on | 2024/08/14 23:02:07 |
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Basic information
Public title
Feasibility of smartphone-based cognitive behavioral therapy for employees
Acronym
Feasibility of smartphone-based cognitive behavioral therapy for employees
Scientific Title
Feasibility of smartphone-based cognitive behavioral therapy for employees
Scientific Title:Acronym
Feasibility of smartphone-based cognitive behavioral therapy for employees
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the feasibility of a smartphone-based cognitive behavioral therapy to improve employees' mental health and presenteeism.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the Brief Job Stress Questionnaire score from pre- to post-intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
All participants will be used smartphone-based cognitive behavioral therapy for one month.
The app consists of four modules (psychological education, relaxation, mindfulness, and behavioral activation).
Based on the assessment, appropriate modules will be offered to participants.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men and women between the ages of 20 and 49
2. They must have their smartphone, either an Apple iPhone or Android device
3. PHQ-9 total scores between 5 and 14, and they have no problem using smartphone-based cognitive behavioral therapy
4. Completion of all the baseline questionnaires at least three days before the start of the study
Key exclusion criteria
1. Cannot read or write Japanese
2. Receiving mental health treatment
3. PHQ-9 total scores less than 5 or higher than 15
4. PHQ-9 scored 2 or 3 on item 9
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kumano |
Organization
Waseda University
Division name
Faculty of Human Science
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
04-2949-8113
hikumano@waseda.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Saito |
Organization
Waseda University
Division name
Comprehensive Research Organization
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama
TEL
04-2949-8113
Homepage URL
tekuteke@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Logos Science Corp.
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
Ethics Review Com mittee , Waseda University
Address
2-579-15, Mikajima, Tokorozawa, Saitama
Tel
03-5272-1639
rinri@list.waseda.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 | 08 | Month | 22 | 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
50
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 | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 14 | Day |
Last modified on
| 2024 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059123
