UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062154 |
|---|---|
| Receipt number | R000070360 |
| Scientific Title | A Non-Randomized Cluster-Controlled Trial to Examine the Effects of a Workplace Mental Health Improvement Program Based on Cognitive Behavioral Therapy Focused on Positive Emotions on Reducing Presenteeism and Enhancing Psychological Resources |
| Date of disclosure of the study information | 2026/07/07 |
| Last modified on | 2026/07/07 10:07:50 |
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Basic information
Public title
A Non-Randomized Cluster-Controlled Trial to Examine the Effects of a Workplace Mental Health Improvement Program Based on Cognitive Behavioral Therapy Focused on Positive Emotions on Reducing Presenteeism and Enhancing Psychological Resources
Acronym
A Non-Randomized Cluster-Controlled Trial to Examine the Effects of a Workplace Mental Health Improvement Program Based on Cognitive Behavioral Therapy Focused on Positive Emotions on Reducing Presenteeism and Enhancing Psychological Resources
Scientific Title
A Non-Randomized Cluster-Controlled Trial to Examine the Effects of a Workplace Mental Health Improvement Program Based on Cognitive Behavioral Therapy Focused on Positive Emotions on Reducing Presenteeism and Enhancing Psychological Resources
Scientific Title:Acronym
A Non-Randomized Cluster-Controlled Trial to Examine the Effects of a Workplace Mental Health Improvement Program Based on Cognitive Behavioral Therapy Focused on Positive Emotions on Reducing Presenteeism and Enhancing Psychological Resources
Region
| Japan |
Condition
Condition
Healthy workers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a workplace group-based mental health improvement program, based on cognitive behavioral therapy, on work performance
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Single-Item Presenteeism Question (SPQ)
Key secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Generalized Anxiety Disorder 7-item scale (GAD-7)
Innovation Mind Scale
World Health Organization-Five Well-Being Index (WHO-5)
Psychological Safety Scale
Cognitive Flexibility Scale
Emotion Regulation Skills Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mental Health Improvement Program Based on Cognitive Behavioral Therapy
Interventions/Control_2
Waiting Group
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
Workers who are not on leave of absence or furlough and do not have significant mental health issues
Key exclusion criteria
Workers who are currently on leave or furlough, or who are undergoing treatment for a mental illness and already have mental health issues
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
260-8677
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Ohashi |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
260-8677
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2975
Homepage URL
shoichi.o@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Kashiwado Memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
Tel
043-226-2975
chibarccmd@ML.chiba-u.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
| 2026 | Year | 07 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 07 | Month | 07 | Day |
Last modified on
| 2026 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070360
