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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043759
Receipt No. 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 2021/03/27

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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
Email 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
Email yuu0323uchi@gmail.com

Sponsor
Institute Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
Email 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 Enrolling by invitation
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 04 Month 01 Day
Last follow-up date
2025 Year 12 Month 31 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
2021 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049955

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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