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).

NCT Number	NCT07299916
Lead Sponsor	The University of Hong Kong
Conditions	Anxiety, GAD
Enrollment	52 participants
Start Date	2025-12-20
Primary Completion	2026-12-30 (estimated)
Study Completion	2027-03-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-29