UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018973 |
|---|---|
| Receipt number | R000021857 |
| Scientific Title | A pilot study of 5-minute Internet based Cognitive Behavioral Therapy Training to promote mental health in the workplace |
| Date of disclosure of the study information | 2015/09/14 |
| Last modified on | 2019/09/13 10:24:26 |
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Basic information
Public title
A pilot study of 5-minute Internet based Cognitive Behavioral Therapy Training to promote mental health in the workplace
Acronym
A pilot study of 5-minute ICBT to promote mental health in the workplace
Scientific Title
A pilot study of 5-minute Internet based Cognitive Behavioral Therapy Training to promote mental health in the workplace
Scientific Title:Acronym
A pilot study of 5-minute ICBT to promote mental health in the workplace
Region
| Japan |
Condition
Condition
Workers
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the efficacy of stress reduction in the workplace by 5-minute Internet based Cognitive Behavioral Therapy Training for 4 weeks, compared with non-intervention
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the Brief Job Stress Questionnaire
before the intervention and after 4-week intervention
Key secondary outcomes
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
5-minute Internet based Cognitive Behavioral Therapy Training
Interventions/Control_2
Non Interventions
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons who are in the Internet Environment for 5-minute Internet based Cognitive Behavioral Therapy Training
Key exclusion criteria
Persons who do not report seeing a doctor regularly
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1 ,Inohana,Chuo-ku,Chiba-shi,Chiba,Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Okamoto |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1, Inohana,Chuo-ku,Chiba-shi,Chiba,Japan
TEL
043-226-2027
Homepage URL
yoko_okamoto@chiba-u.jp
Sponsor or person
Institute
Department of Cognitive Behavioral Physiology ,Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cognitive Behavioral Physiology ,Chiba University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Graduate School of Medicine
Address
1-8-1, Inohana,Chuo-ku,Chiba-shi,Chiba,260-8670,Japan
Tel
043-226-2027
eiji@faculty.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
| 2015 | Year | 09 | Month | 14 | 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
480
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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2019 | 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
| 2015 | Year | 09 | Month | 10 | Day |
Last modified on
| 2019 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021857
