Transcranial Direct Current Stimulation (tDCS) and Immersive Virtual Reality Meditation(IVRM) for the Treatment of Anxiety Disorders: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety Rating Scale (HAM-A)-14 items
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
At the start of each stimulation session, participants in both the active and sham tDCS groups underwent a current ramp-up from 0 to 2 mA; after this initial phase, the current was ramped back down to 0 mA exclusively for the sham group.
Participants were informed that they might experience sensations such as tingling, headache, or mild burning during the first 30-60 seconds of stimulation. They were also told these sensations would likely subside over time as they acclimated to the procedure. This design ensured participants could not distinguish whether a reduction in side effects stemmed from habituation (active tDCS) or the current ramp-down (sham tDCS).
Additionally, the tDCS device's stimulation mode was preconfigured by the principal investigator. This individual was not involved in delivering stimulation or measuring outcomes-two tasks handled by a research assistant who remained blinded to the stimulation mode.
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
active tDCS stimulation + IVRM
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
干预措施: tDCS +IVRM (Active stimulation) (Device)
Sham tDCS stimulation + IVRM
Participants 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.
干预措施: tDCS+IVRM (sham stimulation) (Device)
结局指标
主要结局
Hamilton Anxiety Rating Scale (HAM-A)-14 items
时间窗: 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.
次要结局
- Beck Anxiety Inventory (BAI)(Assessed at Baseline (Day 0), post-intervention (Day 1), and 1-month post-intervention (Month 1))
- State-Trait Anxiety Inventory (STAI)(Assessed at Day 0, Day 14, and Month 1)
- Beck Depression Inventory (BDI)(Assessed at Day 0, Day 14, and Month 1)
- Hamilton Depression Rating Scale (HDRS)(Assessed at Day 0, Day 14, and Month 1)
- Montgomery-Åsberg Depression Rating Scale (MADRS)(Assessed in Day 0, Day 14, Month 1.)
- The Hospital Anxiety and Depression Scale (HADS)(Assessed at Day 0)
- Somatic Symptom Scale (SSS-8)(Assessed Day 0, Day 14, Month 1)
- Depression Anxiety Stress Scales (DASS-21)(Assessed at Day 0, Day 14, Month 1.)
- Perceived Stress Scale (PSS)(Assessed at Day 0, Day 14, Month 1.)
- Penn State Worry Questionnaire (PSWQ)(Assessed at Day 0, Day 14, Month 1.)
- Multidimensional Fatigue Inventory (MFI)(Assessed at Day 0, Day 14, Month 1.)
- Short Form Health Survey (SF-6D)(Assessed at Day 0, Day 14, Month 1)
- Heart rate variability (HRV)(pre- and post-intervention time points; also during the intervention sessions)
- Visual Analog Scale (VAS)(Assessed at Day 14)
- Adverse Effects Questionnaire for tDCS(Day 14 (post-assessment))
- Simulator Sickness Questionnaire (SSQ)(At the end the intervention, Day 14 (Post-assessment))
- Intervention tolerability and drop out rate(Post-assessment, Day 14.)
研究者
Lo Ka Ying
the hku mood team
The University of Hong Kong