UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043759 |
|---|---|
| Receipt number | R000049955 |
| Scientific Title | Exploring features of romantic relationships in chronic depression: a cross-sectional study |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2023/06/11 00:03:19 |
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Basic information
Public title
Exploring features of romantic relationships in chronic depression: a cross-sectional study
Acronym
Exploring features of romantic relationships in chronic depression: a cross-sectional study
Scientific Title
Exploring features of romantic relationships in chronic depression: a cross-sectional study
Scientific Title:Acronym
Exploring features of romantic relationships in chronic depression: a cross-sectional study
Region
| Japan |
Condition
Condition
persistent depressive disorder in DSM-5
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.Are couples' attachment styles associated with the duration of chronic depression?
2.Are couples' attachment styles associated with the severity of chronic depression and marital distress?
3.Are couples' childhood adversity experiences and atypical developmental characteristics (ASD trait, ADHD trait) associated with the duration of chronic depression?
Basic objectives2
Others
Basic objectives -Others
multivariate regression analysis, etc
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the duration of chronic depression
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients:married women who meet DSM-5 criteria for persistent depressive disorder.
2.Patients:those who are under treatment at psychiatric.
3.Patients:those who have married for at least one year and lived with their spouse for at least one year.
4.Patients:those who can give a written informed consent.
5.Spouses: those who can give a written informed consent.
6.Patients and spouses: those who can access to the Internet.
Key exclusion criteria
1.Patients: comorbid psychiatric disorders,i.e.intellectual disability, schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, and neurocognitive disorders.
2.Patients: partial or complete remission in persistent depressive disorder.
3:Patients: other reasons inadequate for study participation.
4.Patients and/or spouses: difficult for understanding the questionnaire in Japanese.
5.Patients and/or spouses: difficult for completing the questionnaire due to mental and/or physical condition.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Toshishige |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Psychiatry and Cognitive-Behavioral Medicine
Zip code
467-8601
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, JAPAN
TEL
052-851-5511
yuu0323uchi@gmail.com
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Toshishige |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Psychiatry and Cognitive-Behavioral Medicine
Zip code
467-8601
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, JAPAN
TEL
052-851-5511
Homepage URL
yuu0323uchi@gmail.com
Sponsor or person
Institute
Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science, and Technology
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
Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, JAPAN
Tel
0528587215
clinical_research@med.nagoya-cu.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational-trans-sectional study
Management information
Registered date
| 2021 | Year | 03 | Month | 27 | Day |
Last modified on
| 2023 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049955
| 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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| Registered date | File name |
