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

Официальное название

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

Обзор

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).

Вмешательства

• Устройство 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
• Устройство 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

Первичные конечные точки

• Hamilton Anxiety Rating Scale (HAM-A)-14 items [Срок оценки: 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)]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• University of Hong Kong, Hong Kong — Гонконг

Идентификаторы

NCT: NCT07299916 · tDCS_anxiety

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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