Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
Modify the research title
Modify the sample collection place
Modify the research titlesample collection place
اصلاح عنوان پژوهش
اصلاح محل جمع آوری نمونه
اصلاح عنوان پژوهشمحل جمع آوری نمونه
Recruitment centers
#1
Name of recruitment center - English: Beautiful Mind Psychology Clinic
Name of recruitment center - Persian: کلینیک روانشناسی ذهن زیبا
Full name of responsible person - English: Jaber Alizadehgoradel
Full name of responsible person - Persian: جابر علیزاده گورادل
Street address - English: Moallem Street - Amin Doctors Building
Street address - Persian: خیابان معلم- ساختمان پزشکان امین
City - English: Ardabil
City - Persian: اردبیل
Province: Ardabil
Country: Iran (Islamic Republic of)
Postal code: 5619163111
Phone: +98 45 3325 0055
Fax:
Email: j.alizadeh45@gmail.com
Web page address:
Name of recruitment center - English: University of Mohaghegh Ardabili
Name of recruitment center - Persian: دانشگاه محقق اردبیلی
Full name of responsible person - English: Eisa Jafari
Full name of responsible person - Persian: عیسی جعفری
Street address - English: University Street - University of Mohaghegh Ardabili
Street address - Persian: خیابان دانشگاه- دانشگاه محقق اردبیلی
City - English: Ardabil
City - Persian: اردبیل
Province: Ardabil
Country: Iran (Islamic Republic of)
Postal code: 5619911367
Phone: +98 45 3150 5000
Fax:
Email: jafari.esa60@gmail.com
Web page address:
Name of recruitment center - English: Beautiful Mind Psychology ClinicUniversity of Mohaghegh Ardabili Name of recruitment center - Persian: کلینیک روانشناسی ذهن زیبادانشگاه محقق اردبیلی Full name of responsible person - English: Jaber AlizadehgoradelEisa Jafari Full name of responsible person - Persian: جابر علیزاده گورادلعیسی جعفری Street address - English: MoallemUniversity Street - Amin Doctors BuildingUniversity of Mohaghegh Ardabili Street address - Persian: خیابان معلمدانشگاه- ساختمان پزشکان امیندانشگاه محقق اردبیلی City - English: Ardabil City - Persian: اردبیل Province: Ardabil Country: Iran (Islamic Republic of) Postal code: 56191631115619911367 Phone: +98 45 3325 00553150 5000 Fax: Email: j.alizadeh45jafari.esa60@gmail.com Web page address:
Protocol summary
Study aim
Determining the the impact of transcranial electrical stimulation over the doroslateral and ventromedial prefrontal cortices on reduction of social anxiety symptoms
Design
The present study is a clinical trial with pre-test, post-test and follow-up design with control group.
Settings and conduct
This study was performed in Ardabil city and among those referred to psychiatric clinics with diagnosis of social anxiety disorder and will be randomly assigned to study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ages 18 to 45 years old; diagnosis of social anxiety disorder based on DSM5 criteria and exclusion criteria: diagnosis of bipolar mood disorder or psychotic disorder based on DSM5 criteria; intracranial implants and a history of epilepsy and seizures.
Intervention groups
Two intervention groups and one control group
Main outcome variables
Symptoms of social anxiety disorder, attention bias, depression, quality of life
General information
Reason for update
Modify the sample collection place
Acronym
IRCT registration information
IRCT registration number:IRCT20181013041327N2
Registration date:2019-12-16, 1398/09/25
Registration timing:prospective
Last update:2021-04-02, 1400/01/13
Update count:2
Registration date
2019-12-16, 1398/09/25
Registrant information
Name
jaber Alizadehgoradel
Name of organization / entity
The University of shahid beheshti
Country
Iran (Islamic Republic of)
Phone
+98 45 3325 0055
Email address
j.alizadeh45@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
2020-01-05, 1398/10/15
Actual recruitment end date
2020-03-15, 1398/12/25
Trial completion date
2020-07-05, 1399/04/15
Scientific title
The impact of transcranial electrical stimulation over the doroslateral and ventromedial prefrontal cortices on reduction of social anxiety symptoms
Public title
Transcranial direct current stimulation and social anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 18 to 45 years old
Diagnosis of social anxiety disorder based on DSM5 criteria
Exclusion criteria:
Diagnosis of bipolar mood disorder or psychotic disorder based on DSM5 criteria
Intracranial Implants
History of epilepsy and seizures
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
36
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
For small studies, random numbers can be used to sort individuals into groups. Persons participating in the research will be given a code or machine number in order to use the random or random numbers table. Since the number of people we want will be selected from 80 people, so the assigned codes and numbers will be double digits. To select sample people from the table, it will randomly start from a table point in the row or column direction. Subjects are then randomly assigned to one of four study groups using the random number table and receive intervention in the same group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, both the participant and the performer are blinded by electrical stimulation and do not know which stimulus is real and which is artificial.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
End of University Street, Ardabil University of Medical Sciences Administrative Complex
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2019-12-01, 1398/09/10
Ethics committee reference number
IR.ARUMS.REC.1398.478
Health conditions studied
1
Description of health condition studied
Social anxiety disorder
ICD-10 code
F40.1
ICD-10 code description
Social phobias
Primary outcomes
1
Description
Symptoms of social anxiety disorder
Timepoint
Before the intervention, after the intervention and three months after the intervention
Method of measurement
Social Anxiety Disorder Questionnaire
2
Description
Attention bias
Timepoint
Before the intervention, after the intervention and three months after the intervention
Method of measurement
Dot probe test
3
Description
Quality of Life
Timepoint
Before the intervention, after the intervention and three months after the intervention
Method of measurement
Quality of Life Questionnaire
4
Description
Depression
Timepoint
Before the intervention, after the intervention and three months after the intervention
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Electrical stimulation of the dorsolateral prefrontal cortex (DLPFC) area with an intensity of 1 mA
Category
Rehabilitation
2
Description
Intervention group 2: Electrical stimulation of the dorsolateral prefrontal cortex (DLPFC) area with an intensity of 2 mA
Category
Rehabilitation
3
Description
Control group: Mock stimulation of orsolateral prefrontal cortex (DLPFC)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Mohaghegh Ardabili
Full name of responsible person
Eisa Jafari
Street address
University Street - University of Mohaghegh Ardabili
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5000
Email
jafari.esa60@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Payame Noor University of Ardabil
Full name of responsible person
Esac Jafari
Street address
Janabazan Square - University Street - Next to Shorabil Recreation Complex - Payame Noor University of Ardabil
City
Ardabil
Province
Ardabil
Postal code
5619913115
Phone
+98 45 3351 3002
Email
jafari.esa60@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Payame Noor University of Ardabil
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Beautiful Mind Psychology Clinic
Full name of responsible person
Jaber Alizadehgoradel
Position
PhD in Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Moallem Street - Amin Doctors Building
City
Ardabil
Province
Ardabil
Postal code
5619163111
Phone
09804533250055
Email
j.alizadeh45@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Beautiful Mind Psychology Clinic
Full name of responsible person
Jaber Alizadehgoradel
Position
PhD in Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Moallem Street - Amin Doctors Building
City
Ardabil
Province
Ardabil
Postal code
5619163111
Phone
+98 45 3325 0055
Email
j.alizadeh45@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Beautiful Mind Psychology Clinic
Full name of responsible person
Jaber Alizadehgoradel
Position
PhD in Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Moallem Street - Amin Doctors Building
City
Ardabil
Province
Ardabil
Postal code
5619163111
Phone
+98 45 3325 0055
Email
j.alizadeh45@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Behavioral data files, study protocols, informed consent forms, and clinical trial reports after identifiable individuals are shared.
When the data will become available and for how long
The access period starts 5 years after the results are published.
To whom data/document is available
Behavioral data for this study will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use of data is permitted only for articles related to the field of addiction.
From where data/document is obtainable
Jaber Alizadehgoradel - j.alizadeh45@gmail.com
What processes are involved for a request to access data/document
Researchers who want to access the data should receive a letter from their workplace university and send it to the responsible person's email address, and the data will be available in less than 1 month.