- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07099521
- Original Trial
The Effects of HD-tDCS on Cognitive Bias Among Individuals With Social Anxiety Symptoms
The Effects of High-definition Transcranial Direct Current Stimulation on Cognitive Bias Among Individuals With Social Anxiety Symptoms
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Guangzhou, China
- School of Psychology, South China Normal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 -24 years old
- No history of major organic brain diseases or mental disorders, and currently not taking hormone or mental disorder drugs, with no drug or alcohol dependence;
- No experience of transcranial direct current stimulation (tDCS) or transcranial magnetic stimulation (TMS) in the past six months;
- Participants are willing to participate and fill out the informed consent form;
- The score of the Patient Health Questionnaire (PHQ-9) is less than 5 points;
- The score of the Liebowitz Social Anxiety Scale (LSAS) is greater than or equal to 55 points
Exclusion Criteria:
- any psychiatric disorders;
- current or past diseases or injuries related to the brain;
- medical pumps, pacemakers and cochlear implants in the body;
- current pharmacological or mental treatments;
- tDCS or TMS experiences over past year were also excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: tDCS group
Participants underwent 10 sessions of anodal (2mA, 20 minutes) HD-tDCS over 5 days targeting the left dorsolateral prefrontal cortex (DLPFC).
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Participants completed 10 sessions of anodal HD-tDCS stimulation over 5 consecutive days (two 20-minute sessions per day, with a 3-hour interval between sessions).
Stimulation was delivered using an HD-tES device (Soterix Medical, Inc, Woodbridge, NJ, USA), targeting the left dorsolateral prefrontal context (DLPFC).
In the active HD-tDCS condition, current was ramped up to 2mA over 30 seconds, maintained for 20 minutes, then ramped down to 0mA at the end.
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Sham Comparator: Sham group
Participants underwent 10 sessions of sham HD-tDCS over 5 days targeting the left dorsolateral prefrontal cortex (DLPFC).
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Participants completed 10 sessions of sham HD-tDCS stimulation over 5 consecutive days (two 20-minute sessions per day, with a 3-hour interval between sessions).
Stimulation was delivered using an HD-tES device (Soterix Medical, Inc, Woodbridge, NJ, USA), targeting the left dorsolateral prefrontal context (DLPFC).
In the sham condition, the current was ramped up to 2mA within the first and last 30 seconds to mimic the sensation of stimulation, but then ramped down, with no current maintained at other times.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Trial-level Bias Score (Negative)
Time Frame: This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5).
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Assessment: Dot probe task;Indicator of Attention Avoidance. Dot probe task is a common experimental paradigm for measuring attention bias. After appearance of a fixed cross in the center of the computer screen, a pair of faces appear side by side. Then, a probe appears on the location previously occupied by one of the two faces. Participants were asked to response the location of the probe as quickly as possible and press the appropriate keys to answer. This study used the trail-level bias score (TL-BS) as a measure of the main outcomes of this task. TL-BS is an indicator of reaction time (RT), calculated by subtracting contiguous pairs of congruent trials (probe and emotional face appeared on the same location of the screen) from incongruent trials (probe and emotional face appeared on the opposite location of the screen).Negative scores represent avoidance of these stimuli. TL-BSnegative indicates the average value of TL-BSs <0ms |
This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5).
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Endorsement Rates of Negative Interpretations
Time Frame: This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5)
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Assessment: Word-sentence association paradigm; Indicator of Negative interpretation bias. Word sentence association paradigm (WSAP) was used to assess the interpretation bias in youth with social anxiety. Following the appearance of a fixed cross (500ms), an ambiguous sentence describing the social situation would be presented in the center of the screen (2000ms). Then, a word would appear at random for 500ms: the word might imply a threatening interpretation (e.g., "boring" or "rejection"), or imply a benign one (e.g., "captivating" or "accepted"). Participants were asked to decide whether the word was related to the ambiguous sentence ("F" for relevant and "J" for irrelevant). This study calculated the proportion of threaten interpretations that participants endorsed as being related to the sentence (Endorsement rates of negative interpretations), which was prescribed as the primary result of interpretation bias. |
This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5)
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Recognition Accuracy for Negative Words
Time Frame: This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5)
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Assessments: recognition task; Indicator of Negative Memory bias.
This study used free recall and recognition task to assess memory bias by the number of positive/negative words remembered.
First, in the "encoding phase", after a short time for a fixed cross, words were presented randomly in turn .
Participants were asked to read these words aloud and answer coding questions.After this phase, there was a 3-minute distraction task, during which participants were guided through 40 calculation problems.
They were then given 2 minutes to freely recall the words that had appeared before, regardless of the order of the words.
Next, they completed a recognition task.
Recognition Accuracy was calculated as: (number of correctly recognized negative words) ÷ (total number of negative words presented).
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This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Peak Trial-level Bias Score (Negative)
Time Frame: This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5)
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Assessments: Dot-probe task; Indicator of Attention Avoidance. Dot probe task is a common experimental paradigm for measuring attention bias. After appearance of a fixed cross in the center of the computer screen, a pair of faces appear side by side. Then, a probe appears on the location previously occupied by one of the two faces. Participants were asked to response the location of the probe as quickly as possible and press the appropriate keys to answer. This study used the trail-level bias score (TL-BS) as a measure of the main outcomes of this task. TL-BS is an indicator of reaction time (RT), calculated by subtracting contiguous pairs of congruent trials (probe and emotional face appeared on the same location of the screen) from incongruent trials (probe and emotional face appeared on the opposite location of the screen).Negative scores represent avoidance of these stimuli. Peak TL-BSnegative indicates the minimum TL-BS value. |
This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5)
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Bias Score
Time Frame: This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5)
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Assessments: Word-sentence association paradigm; Indicator of Negative interpretation bias. Word sentence association paradigm (WSAP) was used to assess the interpretation bias in youth with social anxiety. Following the appearance of a fixed cross (500ms), an ambiguous sentence describing the social situation would be presented in the center of the screen (2000ms). Then, a word would appear at random for 500ms: the word might imply a threatening interpretation (e.g., "boring" or "rejection"), or imply a benign one (e.g., "captivating" or "accepted"). Participants were asked to decide whether the word was related to the ambiguous sentence ("F" for relevant and "J" for irrelevant). This study recorded the response time and calculated the bias index (BI): threat BI = response times (reject threat - endorse threat) and benign BI = response times (endorse benign - reject benign). |
This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5)
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Recall Accuracy for Negative Words
Time Frame: This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5)
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Assessments: free recall task; Indicator of negative memory bias.
This study used free recall and recognition task to assess memory bias by the number of positive/negative words remembered.
First, in the "encoding phase", after a short time for a fixed cross, words were presented randomly in turn .
Participants were asked to read these words aloud and answer coding questions.After this phase, there was a 3-minute distraction task, during which participants were guided through 40 calculation problems.
They were then given 2 minutes to freely recall the words that had appeared before, regardless of the order of the words.
Next, they completed a recognition task.
Recall Accuracy was calculated as: (number of correctly recall negative words) ÷ (total number of negative words presented).
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This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5)
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Social Anxiety Symptoms
Time Frame: Self-report questionnaires were administered at baseline (Day 1), immediately after the last stimulation session (Day 5), and at a 4-week follow-up (Day 30).
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Assessments: the Liebowitz Social Anxiety Scale.
The Liebowitz Social Anxiety Scale (LSAS) was used to identify participants with social anxiety and to assess changes in social anxiety symptoms before and after the tDCS intervention.
The scale contains 24 items, each of which assesses two aspects of fear and avoidance, using a 4-point Likert scale ("0" means "never" and "3" means "severe"), for a total of 48 items.
A higher score indicated more severe social anxiety.
The score ranges from 0 to 144.
The total score would be categorized into 5 severity levels: 0-54 (normal), 55-64 (moderate), 65-79 (marked), 80-94 (severe), and ≥95 (very severe).
In this study, participants scoring between 55 and 95 were included.
The LSAS has demonstrated good internal consistency across three assessments (Cronbach's alpha = 0.87-0.90),
and acceptable test-retest consistency (r = 0.47-0.79,
p < 0.001).
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Self-report questionnaires were administered at baseline (Day 1), immediately after the last stimulation session (Day 5), and at a 4-week follow-up (Day 30).
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Trait Anxiety
Time Frame: Self-report questionnaires were administered at baseline (Day 1), immediately after the last stimulation session (Day 5), and at a 4-week follow-up (Day 30).
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Assessments: the Spielberger Inventory - Trait (STAI-T).
Trait anxiety was assessed using the Spielberger Trait Anxiety Inventory - Trait (STAI-T), which included 20 items rated on a 4-point scale, ranging from 20 to 80 (1 = "not at all" to 4 = "very much").
A higher score indicates severe trait anxiety symptoms.
In this study, the STAI-T demonstrated good internal and test-retest reliability (Cronbach's alpha = 0.80-0.86;
r = 0.69-0.79,
p < 0.001).
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Self-report questionnaires were administered at baseline (Day 1), immediately after the last stimulation session (Day 5), and at a 4-week follow-up (Day 30).
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Negative Cognitive Bias (Attention Bias)
Time Frame: Self-report questionnaires were administered at baseline (Day 1), immediately after the last stimulation session (Day 5), and at a 4-week follow-up (Day 30).
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Assessments: the Negative cognitive processing bias questionnaire; Indicator of self-report attention bias. Participants completed the Negative cognitive processing bias questionnaire (NCPBQ). The NCPBQ included 17 items divided into three subscales, along with three lie-detection items. Among it, the attention bias subscale includes 5 items (E.g., My attention is easily drawn to the tragic images on TV and is difficult to shift). Items were rated on a 5-point Likert scale from 1 ("disagree completely") to 5 ("agree completely"), with higher score indicating more severe cognitive bias. The score of attention bias subscale ranges from 5 to 25. |
Self-report questionnaires were administered at baseline (Day 1), immediately after the last stimulation session (Day 5), and at a 4-week follow-up (Day 30).
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Negative Cognitive Bias (Interpretation Bias)
Time Frame: Self-report questionnaires were administered at baseline (Day 1), immediately after the last stimulation session (Day 5), and at a 4-week follow-up (Day 30).
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Assessments: the Negative cognitive processing bias questionnaire; Indicator of self-report interpretation bias. Participants completed the Negative cognitive processing bias questionnaire (NCPBQ). The NCPBQ included 17 items divided into three subscales, along with three lie-detection items. Among it, the interpretation bias subscale includes 5 items (E.g., If a new teacher is hard on me, I think it is because he sees me in a bad light and wants to get me in trouble). Items were rated on a 5-point Likert scale from 1 ("disagree completely") to 5 ("agree completely"), with higher score indicating more severe cognitive bias . The score of interpretation bias subscale ranges from 5 to 25. |
Self-report questionnaires were administered at baseline (Day 1), immediately after the last stimulation session (Day 5), and at a 4-week follow-up (Day 30).
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Negative Cognitive Bias (Memory Bias)
Time Frame: Self-report questionnaires were administered at baseline (Day 1), immediately after the last stimulation session (Day 5), and at a 4-week follow-up (Day 30).
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Assessments: the Negative cognitive processing bias questionnaire; Indicator of self-report memory bias. Participants completed the Negative cognitive processing bias questionnaire (NCPBQ). The NCPBQ included 17 items divided into three subscales, along with three lie-detection items. Among it, the memory bias subscale includes 4 items (E.g., I can easily remember the negative comments people make about me). Items were rated on a 5-point Likert scale from 1 ("disagree completely") to 5 ("agree completely"), with higher score indicating more severe cognitive bias . The score of memory bias subscale ranges from 5 to 20. |
Self-report questionnaires were administered at baseline (Day 1), immediately after the last stimulation session (Day 5), and at a 4-week follow-up (Day 30).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yi Yu, South China Normal University
- Study Chair: Yuanyuan Wang, South China Normal University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCNU-PSY-2024-185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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