UMIN-CTR Clinical Trial

Basic information
Public title	dr
Acronym	Dr
Scientific Title	The Social Adjustment and Depression during Outbreak of COVID-19 among Iranian people
Scientific Title:Acronym	The Depression during Outbreak of COVID-19
Region	Asia(except Japan)

Condition
Condition	in progress
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	comparison of social adjustment during an outbreak of COVID-19 in Iranian men regarding physical activity participation before the outbreak.
Basic objectives2	Others
Basic objectives -Others	comparison of depression during an outbreak of COVID-19 in Iranian men regarding physical activity participation before the outbreak.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	active individuals have higher/lower social adjustment than inactive individuals. Social adjustment is elated with 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	25 years-old <=
Age-upper limit	50 years-old >=
Gender	Male
Key inclusion criteria	Iranian man among employees in the areas of education, services, banking, executive, technical, medical, and administrative
Key exclusion criteria	completing questionnaire less than 75%
Target sample size	403

Research contact person
Name of lead principal investigator	1st name Faezeh Middle name Last name Zamanian
Organization	The University of Art
Division name	The University of Art
Zip code	1136813518
Address	Iran, Tehran, Hafez bridge
TEL	989131147329
Email	faezezamanian@yahoo.com

Public contact
Name of contact person	1st name Elham Middle name Last name Froozandeh
Organization	Islamic Azad University,
Division name	Naein Branch
Zip code	8391965931
Address	Naein, Iran
TEL	00989128952134
Homepage URL
Email	f.zamanian@art.ac.ir

Sponsor
Institute	The art university of Tehran
Institute
Department

Funding Source
Organization	The art university of Tehran
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	The art university of Tehran
Address	Iran, Tehran, Hafez bridge
Tel	00982166733401
Email	f.zamanian@art.ac.ir

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 02 Month 19 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	2020 Year 06 Month 15 Day
Date of IRB	2020 Year 05 Month 15 Day
Anticipated trial start date	2020 Year 08 Month 16 Day
Last follow-up date	2021 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	the social adjustment, the economic adjustment, the deprassion

Management information
Registered date	2021 Year 01 Month 05 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048996

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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