Protocol summary
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Study aim
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Determining the synergistic effect of CBT with tDCS in regulating brain waves and reducing the signs and symptoms of people with social anxiety.
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Design
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This study includes three groups, two of them are intervention and one of them is sham group. Sample members are randomly assigned to three groups using Excell software. The sample size of this study is 45 people, Considering drop out.
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Settings and conduct
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This research will be performed in person individually by the therapists in Shahid Beheshti Hospital in Zanjan. This study is one-blind and participants will be blind to the groups.
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Participants/Inclusion and exclusion criteria
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Suffering social anxiety disorder; willingness to participate in research; age range minimum 18 and maximum 50 years old; non-smoker; at least third junior high school; no severe psychiatric disorders such as psychotic disorders, cognitive disorders and other psychiatric disorders; lack of history of epileptic seizures and history of head injury; no metal device or other electrical device in the head; do not consume drugs and alcohol; not receiving psychological and technological treatments at least one month before entering the research.
Exclusion criteria: absence for more than two sessions; suicidal ideation during intervention sessions; the need for crisis-related interventions such as medication during intervention sessions; cancel continuation of intervention sessions.
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Intervention groups
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Intervention group 1: first receives transcranial electrical stimulation and in the second stage receives cognitive-behavioral therapy.
Intervention group 2: will receive only transcranial electrical stimulation.
The third group will first receive sham stimulation and then cognitive-behavioral therapy.
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Main outcome variables
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Social anxiety; depression; emotion regulation; attention bias; worry; quality of life; brainwave
General information
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Reason for update
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There is reason to doubt, the information is proven and should be corrected
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220421054607N1
Registration date:
2022-05-19, 1401/02/29
Registration timing:
prospective
Last update:
2024-02-03, 1402/11/14
Update count:
2
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Registration date
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2022-05-19, 1401/02/29
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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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2022-05-26, 1401/03/05
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Expected recruitment end date
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2023-07-21, 1402/04/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Synergistic effect of Transcranial direct current stimulation (tDCS) with cognitive behavioral therapy (CBT) on social anxiety, depression, emotion regulation, quality of life, EEG, attention bias in patients with social phobia disorder: randomize clinical trial
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Public title
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The Synergistic effect of Transcranial direct current stimulation (tDCS) with cognitive behavioral therapy (CBT) in patients with social phobia disorder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Suffering social anxiety disorder
Willingness to participate in research
Age range minimum 18 and maximum 50 years old
Non-smoker
At least third junior high school
No severe psychiatric disorders such as psychotic disorders, cognitive disorders and other psychiatric disorders
Lack of history of epileptic seizures and history of head injury
No metal device or other electrical device in the head
Do not consume drugs and alcohol
Not receiving psychological and technological treatments at least one month before entering the research
Exclusion criteria:
Absence for more than two sessions
Suicidal ideation during intervention sessions
The need for crisis-related interventions such as medication during intervention sessions
Cancel continuation of intervention sessions
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Age
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From 18 years old to 50 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
- Outcome assessor
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Sample size
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Target sample size:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Samples are assigned after screening using Excell program in three groups of treatment number 1, treatment number 2 and sham so that all participants have an equal chance to participate in the groups.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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None of the subjects will know about randomization and the group assignment process.
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Placebo
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Used
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Assignment
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Factorial
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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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2022-04-20, 1401/01/31
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Ethics committee reference number
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IR.ZUMS.REC.1401.029
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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ICD-10 code description
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Primary outcomes
1
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Description
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Social anxiety
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Timepoint
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Before intervention and immediately after intervention and three months after intervention
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Method of measurement
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Liebowitz Social Anxiety Scale
Secondary outcomes
1
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Description
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Depression
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Timepoint
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Before intervention and immediately after intervention and three months after intervention
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Method of measurement
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Beck Depression Inventory-II
2
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Description
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Emotion regulation
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Timepoint
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Before intervention and immediately after intervention and three months after intervention
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Method of measurement
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Difficulties in Emotion Regulation Scale
3
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Description
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Quality of life
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Timepoint
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Before intervention and immediately after intervention and three months after intervention
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Method of measurement
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WHOQUL questionnaire
4
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Description
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Attentional bias
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Timepoint
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Before intervention and immediately after intervention and three months after intervention
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Method of measurement
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Attentional bias task
5
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Description
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Worry
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Timepoint
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Before intervention and immediately after intervention and three months after intervention
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Method of measurement
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Penn State Worry Questionnaire
6
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Description
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Asymmetry of brain waves
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Timepoint
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Before intervention and immediately after intervention and three months after intervention
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Method of measurement
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Electroencephalography
7
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Description
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Coherence of brain waves
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Timepoint
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Before intervention and immediately after intervention and three months after intervention
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Method of measurement
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QEEG
8
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Description
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Amplitude of brain waves
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Timepoint
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Before intervention and immediately after intervention and three months after intervention
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Method of measurement
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QEEG
Intervention groups
1
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Description
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Intervention group 1: Transcranial electrical stimulation for five days. Two sessions every day. Each session is twenty minutes and cognitive-behavioral therapy for fifteen to twenty sessions
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Category
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Treatment - Other
2
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Description
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Intervention group 2: Transcranial electrical stimulation for five days. Two sessions every day. Each session is twenty minutes
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Category
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Treatment - Other
3
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Description
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Control group: Sham cranial electrical stimulation and cognitive-behavioral therapy for fifteen to twenty sessions.
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Category
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Treatment - Other
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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No
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Title of funding source
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Zanjan University of Medical Sciences
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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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Public
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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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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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By observing the data encoding, the whole data can be shared for the unidentifiable people.
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When the data will become available and for how long
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Access period starts 6 months after the results are published
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To whom data/document is available
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All researchers
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Under which criteria data/document could be used
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Allowed for research applications
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From where data/document is obtainable
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Prinaz Sadat Amiri
Email: ami. parinaz 399@gmail.com
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What processes are involved for a request to access data/document
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One Month
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Comments
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