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NCT Number: NCT07299916

Transcranial Direct Current Stimulation (tDCS) and Immersive Virtual Reality Meditation (IVRM) for the Treatment of Anxiety Disorders

The goal of this RCT is to evaluate the post-intervention (week 2) and 1-month post-intervention (week 6) of a 2-week intervention (12 sessions) of combined tDCS (a non-invasive brain stimulation method, with anodal stimulation over lDLPFC and cathodal stimulation over rDLPFC) and immersive virtual reality meditation (IVRM) on anxiety severity among individuals with anxiety disorders, as compared to sham group. We also assess the effects of the intervention on other secondary outcomes as compared to sham group, as well as the tolerability (how well people can handle it) and feasibility (how easy it is to carry out) of this combined intervention.

Exploratory analyses will examine physiological markers, such as heart rate variability (HRV), in relation to treatment response.

Participants will receive total 12 sessions of either active or sham tDCS on DLPFC paired with IVRM. The assessment will be blinded to assessors. No one (participants, researchers, assessors) will be revealed the group allocation. Sham tdcs applies the standard blinding protocol with 30 seconds of ramping up and ramping down periods.

Participants will:

Receive 12 total treatment sessions (twice a day for 2 weeks); each session is 20 minutes of tDCS (active or sham) plus IVRM. The IVRM uses HypnoVR® with 3D scenes (e.g., beach, forest) and 20-minute guided scripts meditation.Take a 20-minute break between the two daily sessions.

Complete assessments at three time points: baseline (before treatment, T0), right after the 2-week treatment (T1), and 1 month after treatment (T2). Assessments include anxiety tests (e.g., HAM-A, Beck Anxiety Inventory), adverse effect questionnaires (for tDCS and IVRM), and physiological checks (e.g., heart rate variability).

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Key information

Conditions

Anxiety Anxiety Disorders GAD Mental Disorders

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hong Kong, Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 16-70 years;
  • Diagnosed with Generalized Anxiety Disorder (GAD) or Mixed Anxiety and Depressive Disorder (MADD) or Major Depressive Disorder with prominent anxiety symptoms, according to the Structured Clinical Interview for DSM-5, Clinical Version (SCID-DSM-5, CV)
  • Scored ≥ 8 (i.e., at least mild to moderate anxiety on the 14-item Hamilton Anxiety Rating Scale (HAM-A)) at screening;
  • Right handedness;
  • Stable dosage of antidepressants or other treatments for depression in recent 4 weeks; and
  • Can read and write Chinese

Exclusion criteria

  • History of significant head trauma, neurological disorders (e.g., epilepsy), seizures, or focal brain lesions;
  • First degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease;
  • Concomitant unstable medical condition or major neurological conditions;
  • Comorbid disorders listed in the DSM-V, e.g., schizophrenia, mental retardation, etc.;
  • Current or history of alcohol or drug abuse;
  • Inability to provide informed consent

Treatment and study plan

tDCS +IVRM (Active stimulation)

Device

Participants will receive 12 combined sessions (twice daily over 2 weeks), with each session being 20 minutes of active tDCS (delivering 2mA current, electrodes placed at left DLPFC (F3, anode) and right DLPFC (F4, cathode)) synchronized with immersive VR; a 20-minute interval between daily sessions .The IVRM will employ guided meditation VR (Brainrise , France) ,as a technology based mindfulness based treatment, with standardised meditation scripts, using Oculus Rift VR headset. The current will be applied with the anode positioned left DLPFC, corresponding to area F3 in the international 10-20 system. The cathode will be applied at the right dPLFC, F4

tDCS+IVRM (sham stimulation)

Device

Participants will receive 12 sessions of sham tDCS stimulation paired with concurrent IVRM. Stimulation is delivered using a tDCS device (Soterix Medical), anodal stimulation at lDLPFC and cathodal stimulation at RFLPFC. The IVRM will employ guided meditation VR (Brainrise , France) ,as a technology based mindfulness based treatment, with standardised meditation scripts, using Oculus Rift VR headset. In the sham condition, the current will be 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.

Primary outcomes

  1. Hamilton Anxiety Rating Scale (HAM-A)-14 items

    Time frame: Assessments are conducted at three time points: Baseline (Day 0, before the start of the intervention), post-intervention (Day 14, immediately after the 2-week combined tDCS-VR intervention), and 1-month post-intervention (Month 1, follow-up)

    The Hamilton Anxiety Rating Scale (HAM-A) is a 14-item clinician-rated tool used to assess the severity of anxiety symptoms, with scores ranging from 0 (minimum) to 56 (maximum); higher scores indicate more severe anxiety.

Secondary outcomes

  1. Beck Anxiety Inventory (BAI)

    Time frame: Assessed at Baseline (Day 0), post-intervention (Day 1), and 1-month post-intervention (Month 1)

    The Beck Anxiety Inventory (BAI) is a 21-item self-report questionnaire designed to measure the severity of anxiety symptoms, with scores ranging from 0 to 63; higher scores indicate greater anxiety.

  2. State-Trait Anxiety Inventory (STAI)

    Time frame: Assessed at Day 0, Day 14, and Month 1

    The State-Trait Anxiety Inventory (STAI) is a 40-item self-report measure that assesses two types of anxiety: state anxiety (temporary condition) and trait anxiety (general tendency), with scores ranging from 20 to 80 for each subscale; higher scores indicate greater anxiety.

  3. Beck Depression Inventory (BDI)

    Time frame: Assessed at Day 0, Day 14, and Month 1

    The Beck Depression Inventory (BDI) is a 21-item self-report questionnaire used to assess the severity of depressive symptoms, with scores ranging from 0 to 63; higher scores indicate more severe depression.

  4. Hamilton Depression Rating Scale (HDRS)

    Time frame: Assessed at Day 0, Day 14, and Month 1

    The Hamilton Depression Rating Scale (HDRS), also known as HAM-D, is a clinician-administered instrument commonly consisting of 17 items used to assess the severity of depressive symptoms, with scores typically ranging from 0 to 52; higher scores reflect more severe depression.

  5. Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: Assessed in Day 0, Day 14, Month 1.

    The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated instrument consisting of 10 items designed to measure the severity of depressive symptoms, with scores ranging from 0 to 60; higher scores indicate more severe depression

  6. The Hospital Anxiety and Depression Scale (HADS)

    Time frame: Assessed at Day 0

    The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire designed to assess symptoms of anxiety (7 items) and depression (7 items) in non-psychiatric hospital settings, with each subscale scoring from 0 to 21; higher scores indicate greater symptom severity.

  7. Somatic Symptom Scale (SSS-8)

    Time frame: Assessed Day 0, Day 14, Month 1

    The Somatic Symptom Scale - 8 (SSS-8) is an 8-item self-report questionnaire designed to assess the burden of somatic symptoms, with scores ranging from 0 to 32; higher scores indicate greater somatic symptom severity

  8. Depression Anxiety Stress Scales (DASS-21)

    Time frame: Assessed at Day 0, Day 14, Month 1.

    The Depression Anxiety Stress Scales - 21 (DASS-21) is a 21-item self-report questionnaire designed to measure the severity of three related emotional states: depression, anxiety, and stress, with each subscale containing 7 items and scoring from 0 to 21; higher scores indicate greater symptom severity.

  9. Perceived Stress Scale (PSS)

    Time frame: Assessed at Day 0, Day 14, Month 1.

    The Perceived Stress Scale (PSS) is a widely used self-report instrument consisting of 10 items that measure the degree to which individuals perceive situations in their life as stressful, with scores ranging from 0 to 40; higher scores indicate greater perceived stress.

  10. Penn State Worry Questionnaire (PSWQ)

    Time frame: Assessed at Day 0, Day 14, Month 1.

    The Penn State Worry Questionnaire (PSWQ) is a 16-item self-report measure designed to assess the trait of worry, particularly its intensity and uncontrollability, with scores ranging from 16 to 80; higher scores indicate greater levels of pathological worry.

  11. Multidimensional Fatigue Inventory (MFI)

    Time frame: Assessed at Day 0, Day 14, Month 1.

    The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report questionnaire designed to assess five dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity, with each subscale scored from 4 to 20; higher scores indicate greater fatigue.

  12. Short Form Health Survey (SF-6D)

    Time frame: Assessed at Day 0, Day 14, Month 1

    Short-form measure of health status from 6 dimensions.The SF-6D has been valued to generate utilities that reflect members of the public's preferences for health on the 0 to 1 utility scale (dead to full health) where values below zero indicate a health state that is considered worse than being dead. The lower the score, the more severe the disease.

  13. Heart rate variability (HRV)

    Time frame: pre- and post-intervention time points; also during the intervention sessions

    By HeartMath Device and PULSAR android app

  14. Visual Analog Scale (VAS)

    Time frame: Assessed at Day 14

    Two VASs items were used to measure motivation and willingness during intervention using a continuous scale. Each VAS contains a scale of 1 (minimum) to 10 (maximum). The total scores ranging from 2 to 20, with higher scores indicating more interest into the program and intervention

  15. Adverse Effects Questionnaire for tDCS

    Time frame: Day 14 (post-assessment)

    Measure the adverse effects during the tDCS treatment period. 10 items of the potential adverse effects of tDCS. This instrument assesses the presence, severity , and perceived relatedness of ten common tDCS-associated sensations (e.g. itching, tingling headache, etc). Severity: For each present item, severity is graded on a 4-point scale (from 1-4): (No, Mild, Moderate, serious). The score ranges from 10-40. The higher the recorded score means the participants perceive more adverse effects from tDCS.

  16. Simulator Sickness Questionnaire (SSQ)

    Time frame: At the end the intervention, Day 14 (Post-assessment)

    Record the Simulator Sickness for VR. There are 16 items, with each from 0-3 severity; The total score ranges from 0-48. Scores reflect the severity, with higher numbers meaning more sickness perceived by the participants.

  17. Intervention tolerability and drop out rate

    Time frame: Post-assessment, Day 14.

    Measure the tolerability and drop out rate during the whole intervention period

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Transcranial Direct Current Stimulation (tDCS) and Immersive Virtual Reality Meditation(IVRM) for the Treatment of Anxiety Disorders: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 23, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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