UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036732 |
|---|---|
| Receipt number | R000041220 |
| Scientific Title | A longitudinal study of stress tolerance related to regional brain volume change based on deep emotion |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2025/05/18 16:39:26 |
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Basic information
Public title
A longitudinal study of stress tolerance related to regional brain volume change based on deep emotion
Acronym
A study of stress tolerance and brain volume change with deep emotion
Scientific Title
A longitudinal study of stress tolerance related to regional brain volume change based on deep emotion
Scientific Title:Acronym
A study of stress tolerance and brain volume change with deep emotion
Region
| Japan |
Condition
Condition
depression, reaction to severe stress, and adjustment disorders
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the relation between regional brain change based on deep emotion and stress tolerance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
At absent from work because of illness or lower performance than usual in work place and 6 months later.
Key secondary outcomes
At time of reinstatement.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Two times MRI scans at sick leave or lower performance than usual in work place and 6 months later.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with depression, reaction to severe stress, or adjustment disorder using ICD10 at sick leave.
Key exclusion criteria
Patients who have contraindication to MRI.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Seishu |
| Middle name | |
| Last name | Nakagawa |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Psychiatry
Zip code
983-8536
Address
Fukumuro, Miyagino-ku, 1-15-11, Sendai, Miyagi
TEL
0222591221
seishu@tohoku-mpu.ac.jp
Public contact
Name of contact person
| 1st name | Seishu |
| Middle name | |
| Last name | Nakagawa |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Psychiatry
Zip code
983-8536
Address
Fukumuro, Miyagino-ku, 1-15-11, Sendai, Miyagi
TEL
0222591221
Homepage URL
seishu@tohoku-mpu.ac.jp
Sponsor or person
Institute
Division of Psychiatry, Tohoku Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Independent Ethics Committee of Tohoku Medical and Pharmaceutical University Hospital
Address
Fukumuro, Miyagino-ku, 1-12-1, Sendai, Miyaagi
Tel
022-259-1221
tikenn@hosp.tohoku-mpu.ac.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
東北医科薬科大学病院 Tohoku Medical and Pharmaceutical University Hospital
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
At enrollment: The severity of depressive symptoms and chronic fatigue was significantly negatively correlated with the degree of general self-efficacy. Perfectionism was positively correlated with chronic fatigue.
Six months later: Loneliness was positively correlated with both depressive symptoms and chronic fatigue. Depressive symptoms were negatively correlated with self-efficacy, but the severity of chronic fatigue was positively correlated with workaholism.
Results date posted
| 2025 | Year | 05 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We have recruited 30 patients for this research.
Management information
Registered date
| 2019 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041220
