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临床试验/NCT07099521
NCT07099521已完成不适用

The Effects of High-definition Transcranial Direct Current Stimulation on Cognitive Bias Among Individuals With Social Anxiety Symptoms

South China Normal University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
Trial-level Bias Score (Negative)

研究概览

简要总结

To examine the offline effects of high-definition tDCS (HD-tDCS) on attention, interpretation and memory biases in youth with social anxiety.

详细描述

In current study, we adopted a comparative intervention study with randomized controlled in which we delivered multiple courses of offline anodal HD-tDCS over the left DLPFC. The aim of this study was to explore the offline impact of HD-tDCS on cognitive bias (including attention, interpretation and memory bias) among youth with social anxiety symptoms. In addition, the researchers sought to further investigate the impact of tDCS stimulation on social anxiety. We hypothesized that anodal tDCS would activates the left DLPFC to facilitate cognitive control of threat-related information among youth with social anxiety, thereby reducing threat attention, interpretation and memory bias, and even improving social anxiety symptoms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

tDCS group

Active Comparator

Participants underwent 10 sessions of anodal (2mA, 20 minutes) HD-tDCS over 5 days targeting the left dorsolateral prefrontal cortex (DLPFC).

干预措施: Active High-definition transcranial direct current stimulation (Device)

Sham group

Sham Comparator

Participants underwent 10 sessions of sham HD-tDCS over 5 days targeting the left dorsolateral prefrontal cortex (DLPFC).

干预措施: Sham high-definition transcranial direct current stimulation (Device)

结局指标

主要结局

Trial-level Bias Score (Negative)

时间窗: This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5).

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

Endorsement Rates of Negative Interpretations

时间窗: This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5)

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.

Recognition Accuracy for Negative Words

时间窗: This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5)

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).

次要结局

  • Peak Trial-level Bias Score (Negative)(This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5))
  • Bias Score(This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5))
  • Recall Accuracy for Negative Words(This task was administered at baseline (Day 1) and immediately after the last stimulation session (Day 5))
  • Social Anxiety Symptoms(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).)
  • Trait Anxiety(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).)
  • Negative Cognitive Bias (Attention Bias)(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).)
  • Negative Cognitive Bias (Interpretation Bias)(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).)
  • Negative Cognitive Bias (Memory Bias)(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).)

研究者

发起方
South China Normal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi Yu

Primary Investigator

South China Normal University

研究点 (1)

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