Intervention Study of Virtual Reality-Based Mindfulness-Based Cognitive Therapy (VR-MBCT) Combined With Adaptive tDCS Modulation for Post-Stroke Depression：A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Change in Patient Health Questionnaire-9 (PHQ-9) Score
研究概览
简要总结
This study investigates whether combining virtual reality mindfulness-based cognitive therapy (VR-MBCT) with transcranial direct current stimulation (tDCS) can effectively treat depression occurring after a stroke (post-stroke depression, PSD). The goal is to determine if this combined approach is more beneficial than either treatment alone or standard care in alleviating depressive symptoms.
The study will enroll adults aged 18-65 who have experienced a stroke within the past week, are medically stable, and exhibit moderate to severe depression symptoms. Participants must be right-handed and able to undergo MRI scans and study assessments. Individuals with certain neurological or psychiatric conditions, other major health issues, or specific contraindications for tDCS will not be eligible.
Procedures:
This is a randomized controlled trial lasting approximately 28 weeks, divided into two phases. In the first phase (8 weeks), participants are randomly assigned to one of four groups:
Group 1: Receives sham (placebo) versions of both VR-MBCT and tDCS plus standard medication.
Group 2: Receives active tDCS and sham VR-MBCT plus standard medication. Group 3: Receives active VR-MBCT and sham tDCS plus standard medication. Group 4: Receives both active VR-MBCT and active tDCS plus standard medication. Treatments are administered 5-6 times per week for 4 weeks, followed by a 4-week blinded follow-up.The primary outcome is the change in depression scores (HDRS-24、PHQ-9) from baseline to 8 weeks. Secondary outcomes include rates of clinical response, remission, relapse, treatment acceptability, and changes in anxiety, sleep quality, and daily functioning.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 65 years (inclusive).
- •Stroke onset ≥ 4 weeks, with stable condition and an NIHSS score ≤
- •Right-handed.
- •Patient must be in a depressive episode, defined by a PHQ-9 score ≥ 5 and confirmed by a HDRS-24 score ≥
- •Has not used any antidepressants before the enrollment.
- •No contraindications to tDCS (e.g., metal plates in the head, brain implants, aneurysm clips, cochlear implants, cardiac pacemakers, etc.).
- •Has not received systematic psychotherapy (such as MBCT, mindfulness training, or cognitive behavioral therapy) for the current or previous depressive episodes.
- •Has more than 8 years of formal education.
- •Has not received tDCS or other transcranial electrical stimulation treatment for the current or previous depressive episodes.
- •Is able to cooperate with multimodal MRI data collection and follow-up assessments, and can understand and comply with the study requirements.
排除标准
- •History of treatment-resistant depression, defined as failure to respond to at least two different antidepressant medications of adequate dosage and duration (at least 8 weeks at the maximum recommended therapeutic dose).
- •Other psychiatric diagnoses (e.g., intellectual disability, schizophrenia, affective psychosis, bipolar disorder, obsessive-compulsive disorder, attention deficit hyperactivity disorder, eating disorders, personality disorders, substance use disorders, post-traumatic stress disorder, panic disorder, or social phobia). Co-morbid anxiety disorder is acceptable.
- •Baseline Mini-Mental State Examination (MMSE) score ≤
- •Presence of suicidal ideation or plan within 4 weeks prior to baseline.
- •Depressive symptoms are better explained by another clinical condition (e.g., hypothyroidism, anemia, congestive heart failure) or other mental disorders.
- •Presence of severe, unstable cardiovascular, hepatic, renal, hematological, endocrine diseases, or malignancies.
- •Laboratory tests indicating significant impairment: total bilirubin (TBIL) > 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times ULN; glomerular filtration rate (GFR) ≤ 70 mL/min; or thyroid-stimulating hormone (TSH) outside the normal range.
- •Poorly controlled hypertension (sitting systolic blood pressure (SBP) ≥ 180 mmHg or sitting diastolic blood pressure (DBP) ≥ 110 mmHg at screening or baseline).
- •Epilepsy and/or other neurological diseases (e.g., dementia, traumatic brain injury, Parkinson's disease, Huntington's disease, multiple sclerosis), or any neurological condition leading to increased intracranial pressure, brain damage, or increased risk of seizures.
- •Pregnant, lactating, or planning pregnancy.
- •Significant visual or hearing impairment that prevents participation in interventions or assessments.
- •Received brain stimulation therapy (e.g., ECT, mECT, TMS, rTMS, deep brain stimulation, vagus nerve stimulation) within 3 months prior to baseline.
- •Participation in another clinical trial within 1 month prior to baseline (excluding screening failures).
- •Any other condition deemed by the investigator as unsuitable for participation in the study.
研究组 & 干预措施
Combined Intervention Group (Active VR-MBCT + Active tDCS)
Receives a 4-week combined intervention of Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT) and active transcranial Direct Current Stimulation (Active tDCS).
干预措施: Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT) (Behavioral)
Combined Intervention Group (Active VR-MBCT + Active tDCS)
Receives a 4-week combined intervention of Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT) and active transcranial Direct Current Stimulation (Active tDCS).
干预措施: Active transcranial Direct Current Stimulation (Active tDCS) (Device)
VR-MBCT Control Group (Active VR-MBCT + Sham tDCS)
Receives a 4-week intervention of Active Virtual Reality Mindfulness-Based Cognitive Therapy (VR-MBCT) concurrent with sham transcranial Direct Current Stimulation (Sham tDCS).
干预措施: Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT) (Behavioral)
VR-MBCT Control Group (Active VR-MBCT + Sham tDCS)
Receives a 4-week intervention of Active Virtual Reality Mindfulness-Based Cognitive Therapy (VR-MBCT) concurrent with sham transcranial Direct Current Stimulation (Sham tDCS).
干预措施: Sham transcranial Direct Current Stimulation (Sham tDCS) (Device)
Active tDCS Control Group (Sham VR-MBCT + Active tDCS)
Receives a 4-week intervention of active transcranial Direct Current Stimulation (Active tDCS) concurrent with sham VR-MBCT (which includes psychoeducation audio and white noise).
干预措施: Active transcranial Direct Current Stimulation (Active tDCS) (Device)
Active tDCS Control Group (Sham VR-MBCT + Active tDCS)
Receives a 4-week intervention of active transcranial Direct Current Stimulation (Active tDCS) concurrent with sham VR-MBCT (which includes psychoeducation audio and white noise).
干预措施: Sham Virtual Reality Mindfulness Program (Sham VR-MBCT) (Behavioral)
Double Control Group (Sham VR-MBCT + Sham tDCS)
Receives a 4-week intervention of sham Virtual Reality Mindfulness-Based Cognitive Therapy (Sham VR-MBCT) concurrent with sham transcranial Direct Current Stimulation (Sham tDCS).
干预措施: Sham Virtual Reality Mindfulness Program (Sham VR-MBCT) (Behavioral)
Double Control Group (Sham VR-MBCT + Sham tDCS)
Receives a 4-week intervention of sham Virtual Reality Mindfulness-Based Cognitive Therapy (Sham VR-MBCT) concurrent with sham transcranial Direct Current Stimulation (Sham tDCS).
干预措施: Sham transcranial Direct Current Stimulation (Sham tDCS) (Device)
结局指标
主要结局
Change in Patient Health Questionnaire-9 (PHQ-9) Score
时间窗: Baseline , Week 1, Week 2, Week 3, Week 4, Week 8, Week 28
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report scale for assessing depressive symptom severity based on frequency over the past two weeks. Total scores range from 0 to 27, with higher scores indicating greater depression severity. Change in total score from Baseline to Week 28 serves as a primary efficacy measure.
Hamilton Depression Rating Scale-24 (HDRS-24) Score
时间窗: Baseline , Week 1, Week 2, Week 3, Week 4, Week 8, Week 28
The Hamilton Depression Rating Scale-24 item (HDRS-24) is a clinician-administered scale for assessing depressive symptom severity. Total scores range from 0 to 74, with higher scores indicating greater depression severity. Change in total score from Baseline to Week 28 serves as a primary efficacy measure.
次要结局
- Treatment Retention Rate(Week 4)
- Intervention Adherence Rate(Week 4)
- Change in HAMA Score(Baseline, Week 4, Week 8, Week 28)
- Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score(Baseline, Week 4, Week 8, Week 28)
- Change in Five Facet Mindfulness Questionnaire (FFMQ) Score(Baseline, Week 4, Week 8, Week 28)
- Change in Pittsburgh Sleep Quality Index (PSQI) Score(Baseline, Week 4, Week 8, Week 28)
- Change in Patient Health Questionnaire-15 (PHQ-15) Score(Baseline, Week 4, Week 8, Week 28)
- Change in modified Rankin Scale (mRS) Score(Baseline, Week 4, Week 8, Week 28)
- Change in 36-Item Short Form Health Survey (SF-36) Score(Baseline, Week 4, Week 8, Week 28)
- Change in Hospital Anxiety and Depression Scale (HADS) Score(Baseline, Week 4, Week 8, Week 28)
- Change in resting-state functional connectivity (fMRI)(Baseline, Week 4, Week 28)