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

Official title

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

Overview

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).

Interventions

• Device tDCS +IVRM (Active stimulation)
  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 wil
• Device tDCS+IVRM (sham stimulation)
  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

Primary outcome measures

• 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)]

Secondary outcome measures (12)

• Beck Anxiety Inventory (BAI) [Time frame: Assessed at Baseline (Day 0), post-intervention (Day 1), and 1-month post-intervention (Month 1)]
• State-Trait Anxiety Inventory (STAI) [Time frame: Assessed at Day 0, Day 14, and Month 1]
• Beck Depression Inventory (BDI) [Time frame: Assessed at Day 0, Day 14, and Month 1]
• Hamilton Depression Rating Scale (HDRS) [Time frame: Assessed at Day 0, Day 14, and Month 1]
• Montgomery-Åsberg Depression Rating Scale (MADRS) [Time frame: Assessed in Day 0, Day 14, Month 1.]
• The Hospital Anxiety and Depression Scale (HADS) [Time frame: Assessed at Day 0]
• Somatic Symptom Scale (SSS-8) [Time frame: Assessed Day 0, Day 14, Month 1]
• Depression Anxiety Stress Scales (DASS-21) [Time frame: Assessed at Day 0, Day 14, Month 1.]
• Perceived Stress Scale (PSS) [Time frame: Assessed at Day 0, Day 14, Month 1.]
• Penn State Worry Questionnaire (PSWQ) [Time frame: Assessed at Day 0, Day 14, Month 1.]
• Multidimensional Fatigue Inventory (MFI) [Time frame: Assessed at Day 0, Day 14, Month 1.]
• Short Form Health Survey (SF-6D) [Time frame: Assessed at Day 0, Day 14, Month 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• University of Hong Kong, Hong Kong — Hong Kong

Identifiers

NCT: NCT07299916 · tDCS_anxiety

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗