UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053159 |
|---|---|
| Receipt number | R000060559 |
| Scientific Title | Effects of web-based psycho-education of Memory Rescripting for work-related stress: A pilot randomized controlled trial |
| Date of disclosure of the study information | 2023/12/21 |
| Last modified on | 2024/01/02 12:20:30 |
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Basic information
Public title
Effects of web-based psycho-education of Memory Rescripting for work-related stress: A pilot randomized controlled trial
Acronym
Effects of web-based psycho-education of Memory Rescripting for work-related stress: A pilot randomized controlled trial
Scientific Title
Effects of web-based psycho-education of Memory Rescripting for work-related stress: A pilot randomized controlled trial
Scientific Title:Acronym
Effects of web-based psycho-education of Memory Rescripting for work-related stress: A pilot randomized controlled trial
Region
| Japan |
Condition
Condition
psychological distress in relation to work-related stressful memory
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a pilot randomozied controlled trial to examine web-based self-help psycho-education of memory rescripting for work-related stress for adult workers without medical care, who had psychological distress in relation to work-related stressful memory, compared with control.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Impact of Event Scale-Revised (IES-R)
Key secondary outcomes
WHO Health and Work Performance Questionnaire
Patient Health Questionnaire-9
Generalized Anxiety Disorder-7
Athens Insomnia Scale
The Center for Epidemiologic Studies Depression Scale
Brief Core Schema Scale
Strength and Difficulties Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Web-based psychoeducational program that enables you to be compassionate toward yourself by using memory (imagery) rescripting.
Interventions/Control_2
Web-based sham program
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
Persons between the ages of 18 and 65
Persons who are well at the time of consent, and who are not undergoing treatment for a mental or physical illness.
Persons working at least 20 hours per week
Persons who are still suffering from psychological distress in relation to work-related stressful memory
(total score of 25 or more on the IES-R (Impact of Event Scale-Revised) and wish to reduce distress through web psycho-education.
Persons who have internet access uging computer, smartphone, tablet and so on, and can use it for approximately 8 weeks (2 months).
Persons who can understand the explanation in Japanese and give their free and voluntary consent on the web.
Key exclusion criteria
Persons who have been diagnosed with any mental disorder including schizophrenia, bipolar disorder, depression, and alcohol dependence.
Persons who have symptoms of depression or anxiety (PHQ-9 score of 20 or higher or GAD-7 score of 15 or higher at screening)
Persons who have suicidal ideation (score of 2 or more on the item 9 of the PHQ-9 at screening)
Persons whose most recent physical examination indicated that they require close examination or treatment
(however, those with A: no abnormality, B: mild abnormality, and C: reexamination or lifestyle improvement required are not excluded).
Persons who have been found to be in a high stress state in the most recent stress check,
or those who are experiencing high stress in their current workplace.
Persons deemed by the investigator to be unsuitable for the safe conduct of this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University
Division name
Graduate School of Medicine, Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan
TEL
81-43-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Akane |
| Middle name | |
| Last name | Uratani |
Organization
Chiba University
Division name
Graduate School of Medicine, Department of Cognitive Behavioral Physiology,
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan
TEL
81-43-226-2027
Homepage URL
23fm0103@student.gs.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
The Research Institute of Economy, Trade and Industr
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 Hospital institutional review board (IRB)
Address
1-8-1 Inohana Chuo-ku Chiba 260-8677, Japan
Tel
81-43-222-7171
hsp-chibacrc@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
| 2023 | Year | 12 | Month | 21 | 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
| 2023 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | 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 | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060559
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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