Intervention Study of Virtual Reality-Based Mindfulness-Based Cognitive Therapy (VR-MBCT) Combined With Adaptive tDCS Modulation for Post-Stroke Depression

NCT07422740 | Not Yet Recruiting

• 1 other identifier: 2025-0626
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Post-stroke Depression

Keywords

Post-stroke depression; Transcranial direct current stimulation; Virtual reality mindfulness-based cognitive therapy

Outcome Measures

Primary Outcomes (2)

• Change in Patient Health Questionnaire-9 (PHQ-9) Score

  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.

  Baseline , Week 1, Week 2, Week 3, Week 4, Week 8, Week 28

• Hamilton Depression Rating Scale-24 (HDRS-24) Score

  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.

  Baseline , Week 1, Week 2, Week 3, Week 4, Week 8, Week 28

Secondary Outcomes (11)

• 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

Study Arms (4)

Combined Intervention Group (Active VR-MBCT + Active tDCS)

EXPERIMENTAL

Receives a 4-week combined intervention of Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT) and active transcranial Direct Current Stimulation (Active tDCS).

Behavioral: Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT); Device: Active transcranial Direct Current Stimulation (Active tDCS)

VR-MBCT Control Group (Active VR-MBCT + Sham tDCS)

ACTIVE COMPARATOR

Receives a 4-week intervention of Active Virtual Reality Mindfulness-Based Cognitive Therapy (VR-MBCT) concurrent with sham transcranial Direct Current Stimulation (Sham tDCS).

Behavioral: Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT); Device: Sham transcranial Direct Current Stimulation (Sham tDCS)

Active tDCS Control Group (Sham VR-MBCT + Active tDCS)

ACTIVE COMPARATOR

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).

Device: Active transcranial Direct Current Stimulation (Active tDCS); Behavioral: Sham Virtual Reality Mindfulness Program (Sham VR-MBCT)

Double Control Group (Sham VR-MBCT + Sham tDCS)

SHAM COMPARATOR

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).

Behavioral: Sham Virtual Reality Mindfulness Program (Sham VR-MBCT); Device: Sham transcranial Direct Current Stimulation (Sham tDCS)

Interventions

Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT) BEHAVIORAL

Participants will receive a structured Virtual Reality Mindfulness-Based Cognitive Therapy program specifically designed for post-stroke depression. The intervention aims to improve emotional regulation and cognitive function through immersive mindfulness exercises. It is administered 5 sessions per week for 4 weeks, with each session lasting approximately 30 minutes. The content includes breathing techniques, and mindfulness practices within a virtual reality environment.

Combined Intervention Group (Active VR-MBCT + Active tDCS); VR-MBCT Control Group (Active VR-MBCT + Sham tDCS)

Sham Virtual Reality Mindfulness Program (Sham VR-MBCT) BEHAVIORAL

Participants in the control groups will experience a sham VR program. It uses the same virtual reality hardware but presents neutral, non-therapeutic content (e.g., nature scenes without guided mindfulness instruction) accompanied by audio containing general psychoeducation about stroke recovery and white noise. The frequency and duration (5 sessions/week, 30 minutes/session for 4 weeks) match the Active VR-MBCT intervention to control for non-specific effects like attention and device use.

Active tDCS Control Group (Sham VR-MBCT + Active tDCS); Double Control Group (Sham VR-MBCT + Sham tDCS)

Active transcranial Direct Current Stimulation (Active tDCS) DEVICE

Participants will receive active transcranial Direct Current Stimulation using a programmable stimulator. The anodal electrode will be placed over the left dorsolateral prefrontal cortex (DLPFC) and the cathodal electrode over the right supraorbital area. Stimulation will be administered at 2.0 mA for 30 minutes per session, once daily, for 4 weeks. The device delivers a constant, low-intensity electrical current intended to modulate cortical excitability.

Active tDCS Control Group (Sham VR-MBCT + Active tDCS); Combined Intervention Group (Active VR-MBCT + Active tDCS)

Sham transcranial Direct Current Stimulation (Sham tDCS) DEVICE

The sham tDCS intervention uses the same device and setup as the Active tDCS arm to maintain blinding. The device will deliver a brief initial current ramp (e.g., 30 seconds) to mimic the sensory skin sensation (tingling/itching) of active stimulation, but will then automatically shut off or deliver only a negligible current for the remainder of the 30-minute session. This procedure ensures participants cannot distinguish it from the active stimulation based on initial sensation alone.

Double Control Group (Sham VR-MBCT + Sham tDCS); VR-MBCT Control Group (Active VR-MBCT + Sham tDCS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 65 years (inclusive).
• Stroke onset ≥ 4 weeks, with stable condition and an NIHSS score ≤ 15.
• Right-handed.
• Patient must be in a depressive episode, defined by a PHQ-9 score ≥ 5 and confirmed by a HDRS-24 score ≥ 8.
• 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.

You may not qualify if:

• 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 ≤ 24.
• 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.

Sponsors & Collaborators

• Hangzhou Seventh People's Hospital, Affiliated Mental Health Center, Zhejiang University School of Medicine: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Central Study Contacts

Lusha Tong, MD

CONTACT

086+15868171218; 2310040@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 20, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 20, 2026

Record last verified: 2025-06