UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054001 |
|---|---|
| Receipt number | R000061644 |
| Scientific Title | Preliminary study for organizing and developing evidence for PRO indicators for depression, anxiety, and premenstrual syndrome used in healthcare |
| Date of disclosure of the study information | 2024/03/30 |
| Last modified on | 2024/05/05 15:26:35 |
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Basic information
Public title
Preliminary study for organizing and developing evidence for PRO indicators for depression, anxiety, and premenstrual syndrome used in healthcare
Acronym
Preliminary study for organizing and developing evidence for patient reported outcome indicators for depression, anxiety, and premenstrual syndrome used in healthcare
Scientific Title
Preliminary study for organizing and developing evidence for PRO indicators for depression, anxiety, and premenstrual syndrome used in healthcare
Scientific Title:Acronym
Preliminary study for organizing and developing evidence for PRO indicators for depression, anxiety, and premenstrual syndrome used in healthcare
Region
| Japan |
Condition
Condition
sub threshold depression, sub threshold anxiety, premenstrual syndrome
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this project, we aim to build a foundation to accumulate evidence and to enable the social implementation of health care services based on scientific evidence, and we will work on the following two tasks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Minimally Important Difference, MID
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
We provide psychoeducation based on cognitive behavioral therapy and stories (reading materials) that encourage behavior change, reading one a day.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Persons who work more than 32 hours a week
-You have never been seen or diagnosed with depression, anxiety, or premenstrual syndrome.
-Persons who do not have suicidal thoughts (score for suicidal thoughts in question 9 of the depression scale PHQ-9 is 0 or 1)
-Person who has an Internet environment (PC, smartphone, or tablet)
-Persons who have Japanese nationality, can understand explanations in Japanese, and can consent online of their own free will.
*Registration conditions for premenstrual syndrome
1) Women aged 18 to 45
2) Regular menstrual cycle (25 to 38 day cycle)
Key exclusion criteria
1) Depression is defined by a PHQ-9 score of 15 points or higher, anxiety is defined by a GAD-7 score of 15 points or higher, and premenstrual syndrome is defined by a score of 15 points or higher on the PHQ-9.
People who fall under PMDD according to the PMDD rating scale
2) People with gynecological diseases (fibroids, endometriosis, etc.)
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Numata |
Organization
Chiba University
Division name
Graduate School of Medicine, Cognitive Behavioral Physiology
Zip code
2608670
Address
1-8-1, Inohana Chuo-ku, Chiba city
TEL
043-226-2027
n_numata@chiba-u.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Numata |
Organization
Chiba University
Division name
Graduate School of Medicine, Cognitive Behavioral Physiology
Zip code
2608670
Address
1-8-1, Inohana Chuo-ku, Chiba city
TEL
043-226-2027
Homepage URL
n_numata@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 Chuo-ku, Chiba city
Tel
043-226-2027
n_numata@chiba-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
23rea522113h0001
Org. issuing International ID_1
Japan agency for medical research and development
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 30 | 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
400
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
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061644
