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NCT Number: NCT07422740

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

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.

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Key information

Conditions

Post-stroke Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Change in Patient Health Questionnaire-9 (PHQ-9) Score

    Time frame: 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.

  2. Hamilton Depression Rating Scale-24 (HDRS-24) Score

    Time frame: 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.

Secondary outcomes

  1. Treatment Retention Rate

    Time frame: Week 4

    The proportion of participants who remain in the study and complete the assigned intervention by the end of Week 4. This will be calculated separately for each group as: (Number of participants randomized - Number of participants who withdrew prior to Week 4) / Number of participants randomized × 100%.

  2. Intervention Adherence Rate

    Time frame: Week 4

    The degree to which participants complete the prescribed intervention sessions. It will be calculated as the total minutes of intervention sessions actually attended (or completed in the VR system) divided by the total minutes of intervention sessions prescribed by the protocol up to Week 4, expressed as a percentage. Adherence data will be objectively recorded by the VR system.

  3. Change in HAMA Score

    Time frame: Baseline, Week 4, Week 8, Week 28

    The Hamilton Anxiety Rating Scale (HAMA) is a clinician-administered scale used to rate the severity of anxiety symptoms. Total scores range from 0 to 56, with higher scores indicating greater severity of anxiety. The change from baseline to post-intervention will be calculated

  4. Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score

    Time frame: Baseline, Week 4, Week 8, Week 28

    The SHAPS is a 14-item scale measuring the ability to experience pleasure. Total scores range from 14 to 56, with higher scores indicating higher levels of anhedonia (reduced pleasure capacity).The change from baseline to post-intervention will be calculated.

  5. Change in Five Facet Mindfulness Questionnaire (FFMQ) Score

    Time frame: Baseline, Week 4, Week 8, Week 28

    The FFMQ is a 39-item self-report questionnaire measuring five facets of mindfulness. The total score ranges from 39 to 195, with higher scores indicating higher levels of mindfulness.The change from baseline to post-intervention will be calculated.

  6. Change in Pittsburgh Sleep Quality Index (PSQI) Score

    Time frame: Baseline, Week 4, Week 8, Week 28

    The PSQI is a 19-item self-report scale assessing sleep quality and disturbances over a 1-month interval. The global score ranges from 0 to 21, with higher scores indicating worse sleep quality.The change from baseline to post-intervention will be calculated.

  7. Change in Patient Health Questionnaire-15 (PHQ-15) Score

    Time frame: Baseline, Week 4, Week 8, Week 28

    The PHQ-15 is a self-report scale for assessing somatic symptom severity. Scores range from 0 to 30, with higher scores indicating greater severity of somatic symptoms.The change from baseline to post-intervention will be calculated.

  8. Change in modified Rankin Scale (mRS) Score

    Time frame: Baseline, Week 4, Week 8, Week 28

    The mRS is a clinician-reported measure of global disability after neurological injury, such as stroke. Scores range from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability.The change from baseline to post-intervention will be calculated.

  9. Change in 36-Item Short Form Health Survey (SF-36) Score

    Time frame: Baseline, Week 4, Week 8, Week 28

    The SF-36 is a self-reported survey of health status. It yields scores for 8 domains and two summary scores (Physical and Mental Component Summaries). Scores are transformed to a range of 0 to 100, with higher scores indicating better health-related quality of life.The change from baseline to post-intervention will be calculated.

  10. Change in Hospital Anxiety and Depression Scale (HADS) Score

    Time frame: Baseline, Week 4, Week 8, Week 28

    The HADS is a 14-item self-report questionnaire specifically designed to screen for anxiety and depressive states in non-psychiatric hospital settings, minimizing the influence of physical illness symptoms. It comprises two subscales (Anxiety and Depression), each with scores ranging from 0 to 21. Higher scores on each subscale indicate greater severity of anxiety or depressive symptoms, respectively.The change from baseline to post-intervention will be calculated.

  11. Change in resting-state functional connectivity (fMRI)

    Time frame: Baseline, Week 4, Week 28

    Resting-state functional magnetic resonance imaging (fMRI) is used to assess changes in functional brain network connectivity. Key metrics include alterations in the strength of functional connectivity within and between brain networks relevant to depression and cognition (e.g., Default Mode Network, Central Executive Network). The change in connectivity metrics from baseline to post-intervention will be calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Lusha Tong, MD

CONTACT

[email protected]

086+15868171218

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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