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AnxietyNCT07299916

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

A study testing tDCS +IVRM (Active stimulation) in people with Anxiety and GAD, run by The University of Hong Kong at 1 site in Hong Kong.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 16 to 70 years
Conditions the study is for
Anxiety, GAD
What is being tested?
tDCS +IVRM (Active stimulation)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 siteHong Kong
Study dates
20 Dec 2025to 30 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hong Kong1 site
  • University of Hong Kong, Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

Read more

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).

Conditions
Anxiety, GAD
Being tested
tDCS +IVRM (Active stimulation), tDCS+IVRM (sham stimulation)
Keywords
immersive virtual reality meditation, Transcranial Direct Current Stimulation (tDCS), Augmentative treatment
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07299916
Study groupRoleWhat they receive
active tDCS stimulation + IVRMExperimentalParticipants 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
Receives: Device: tDCS +IVRM (Active stimulation)
Sham tDCS stimulation + IVRMSham comparatorParticipants will receive 12 combined sessions (twice daily over 2 weeks), with each session being 20 minutes of sham tDCS synchronized with immersive VR; a 20-minute interval between daily sessions. 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. Moreover, the stimulation mode of the tDCS device will be pre-set by a the principal investigator, who are not involved in the stimulation delivery or outcome measurements, both of which are conducted by a research assistant who are blinded to the stimulation mode.
Receives: Device: tDCS+IVRM (sham stimulation)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 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)

Secondary outcomes (17)
  1. Beck Anxiety Inventory (BAI)

    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.

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

  2. State-Trait Anxiety Inventory (STAI)

    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.

    Measured: Assessed at Day 0, Day 14, and Month 1

  3. Beck Depression Inventory (BDI)

    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.

    Measured: Assessed at Day 0, Day 14, and Month 1

  4. Hamilton Depression Rating Scale (HDRS)

    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.

    Measured: Assessed at Day 0, Day 14, and Month 1

  5. Montgomery-Åsberg Depression Rating Scale (MADRS)

    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

    Measured: Assessed in Day 0, Day 14, Month 1.

  6. The Hospital Anxiety and Depression Scale (HADS)

    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.

    Measured: Assessed at Day 0

  7. Somatic Symptom Scale (SSS-8)

    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

    Measured: Assessed Day 0, Day 14, Month 1

  8. Depression Anxiety Stress Scales (DASS-21)

    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.

    Measured: Assessed at Day 0, Day 14, Month 1.

  9. Perceived Stress Scale (PSS)

    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.

    Measured: Assessed at Day 0, Day 14, Month 1.

  10. Penn State Worry Questionnaire (PSWQ)

    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.

    Measured: Assessed at Day 0, Day 14, Month 1.

  11. Multidimensional Fatigue Inventory (MFI)

    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.

    Measured: Assessed at Day 0, Day 14, Month 1.

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

    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.

    Measured: Assessed at Day 0, Day 14, Month 1

  13. Heart rate variability (HRV)

    By HeartMath Device and PULSAR android app

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

  14. Visual Analog Scale (VAS)

    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

    Measured: Assessed at Day 14

  15. Adverse Effects Questionnaire for tDCS

    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.

    Measured: Day 14 (post-assessment)

  16. Simulator Sickness Questionnaire (SSQ)

    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.

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

  17. Intervention tolerability and drop out rate

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

    Measured: Post-assessment, Day 14.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2025
  2. Study start20 Dec 2025
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07299916
Sponsor's protocol ID
tDCS_anxiety
Status last verified
Apr 2026
First submitted
25 Nov 2025
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing tDCS +IVRM (Active stimulation) in people with Anxiety and GAD, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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