Protocol summary
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Study aim
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Determining the the impact of transcranial electrical stimulation over the doroslateral and ventromedial prefrontal cortices on reduction of social anxiety symptoms
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Design
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The present study is a clinical trial with pre-test, post-test and follow-up design with control group.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Two intervention groups and one control group
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Main outcome variables
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Symptoms of social anxiety disorder, attention bias, depression, quality of life
General information
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Reason for update
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Modify the sample collection place
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Acronym
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IRCT registration information
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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
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Registration date
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2019-12-16, 1398/09/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-12-22, 1398/10/01
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Expected recruitment end date
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2020-05-09, 1399/02/20
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Actual recruitment start date
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2020-01-05, 1398/10/15
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Actual recruitment end date
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2020-03-15, 1398/12/25
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Trial completion date
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2020-07-05, 1399/04/15
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Scientific title
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The impact of transcranial electrical stimulation over the doroslateral and ventromedial prefrontal cortices on reduction of social anxiety symptoms
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Public title
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Transcranial direct current stimulation and social anxiety disorder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 45 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
36
Actual sample size reached:
36
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-12-01, 1398/09/10
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Ethics committee reference number
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IR.ARUMS.REC.1398.478
Health conditions studied
1
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Description of health condition studied
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Social anxiety disorder
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ICD-10 code
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F40.1
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ICD-10 code description
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Social phobias
Primary outcomes
1
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Description
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Symptoms of social anxiety disorder
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Timepoint
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Before the intervention, after the intervention and three months after the intervention
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Method of measurement
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Social Anxiety Disorder Questionnaire
2
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Description
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Attention bias
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Timepoint
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Before the intervention, after the intervention and three months after the intervention
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Method of measurement
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Dot probe test
3
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Description
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Quality of Life
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Timepoint
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Before the intervention, after the intervention and three months after the intervention
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Method of measurement
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Quality of Life Questionnaire
4
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Description
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Depression
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Timepoint
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Before the intervention, after the intervention and three months after the intervention
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Method of measurement
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Beck Depression Inventory
Intervention groups
1
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Description
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Intervention group: Electrical stimulation of the dorsolateral prefrontal cortex (DLPFC) area with an intensity of 1 mA
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Category
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Rehabilitation
2
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Description
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Intervention group 2: Electrical stimulation of the dorsolateral prefrontal cortex (DLPFC) area with an intensity of 2 mA
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Category
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Rehabilitation
3
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Description
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Control group: Mock stimulation of orsolateral prefrontal cortex (DLPFC)
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Payame Noor University of Ardabil
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Behavioral data files, study protocols, informed consent forms, and clinical trial reports after identifiable individuals are shared.
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When the data will become available and for how long
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The access period starts 5 years after the results are published.
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To whom data/document is available
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Behavioral data for this study will only be available to researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Use of data is permitted only for articles related to the field of addiction.
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From where data/document is obtainable
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Jaber Alizadehgoradel - j.alizadeh45@gmail.com
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What processes are involved for a request to access data/document
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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.
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Comments
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