NCT07099521

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
4 months until next milestone

Results Posted

Study results publicly available

December 10, 2025

Completed
Last Updated

December 10, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

July 25, 2025

Results QC Date

August 30, 2025

Last Update Submit

November 24, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Trial-level Bias Score (Negative)

    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).

  • Endorsement Rates of Negative Interpretations

    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)

  • Recognition Accuracy for Negative Words

    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).

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

Secondary Outcomes (8)

  • 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).

  • +3 more secondary outcomes

Study Arms (2)

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).

Device: Active High-definition transcranial direct current stimulation

Sham group

SHAM COMPARATOR

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

Device: Sham high-definition transcranial direct current stimulation

Interventions

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.

tDCS group

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.

Sham group

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Psychology, South China Normal University

Guangzhou, China

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Results Point of Contact

Title
Dr. Yuanyuan Wang
Organization
South China Normal University

Study Officials

  • Yi Yu

    South China Normal University

    PRINCIPAL INVESTIGATOR
  • Yuanyuan Wang

    South China Normal University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 1, 2025

Study Start

May 15, 2024

Primary Completion

November 24, 2024

Study Completion

December 24, 2024

Last Updated

December 10, 2025

Results First Posted

December 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

The original data will not be made public before the paper is published

Locations