Post-stroke DepressionNCT07422740
Intervention Study of Virtual Reality-Based Mindfulness-Based Cognitive Therapy (VR-MBCT) Combined With Adaptive tDCS Modulation for Post-Stroke Depression
A study testing Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT) and Active transcranial Direct Current Stimulation (Active tDCS) in people with Post-stroke Depression, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT) and Active transcranial Direct Current Stimulation (Active tDCS)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read more
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
- Being tested
- Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT), Active transcranial Direct Current Stimulation (Active tDCS), Sham Virtual Reality Mindfulness Program (Sham VR-MBCT), Sham transcranial Direct Current Stimulation (Sham tDCS)
- Keywords
- Post-stroke depression, Transcranial direct current stimulation, Virtual reality mindfulness-based cognitive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Behavioral: Sham Virtual Reality Mindfulness Program (Sham VR-MBCT); Device: Sham transcranial Direct Current Stimulation (Sham tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline , Week 1, Week 2, Week 3, Week 4, Week 8, Week 28
Secondary outcomes (11)
Treatment Retention Rate
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%.
Measured: Week 4
Intervention Adherence Rate
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.
Measured: Week 4
Change in HAMA Score
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
Measured: Baseline, Week 4, Week 8, Week 28
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score
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.
Measured: Baseline, Week 4, Week 8, Week 28
Change in Five Facet Mindfulness Questionnaire (FFMQ) Score
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.
Measured: Baseline, Week 4, Week 8, Week 28
Change in Pittsburgh Sleep Quality Index (PSQI) Score
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.
Measured: Baseline, Week 4, Week 8, Week 28
Change in Patient Health Questionnaire-15 (PHQ-15) Score
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.
Measured: Baseline, Week 4, Week 8, Week 28
Change in modified Rankin Scale (mRS) Score
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.
Measured: Baseline, Week 4, Week 8, Week 28
Change in 36-Item Short Form Health Survey (SF-36) Score
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.
Measured: Baseline, Week 4, Week 8, Week 28
Change in Hospital Anxiety and Depression Scale (HADS) Score
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.
Measured: Baseline, Week 4, Week 8, Week 28
Change in resting-state functional connectivity (fMRI)
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.
Measured: Baseline, Week 4, Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start10 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Seventh People's Hospital, Affiliated Mental Health Center, Zhejiang University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422740
- Sponsor's protocol ID
- 2025-0626
- Status last verified
- Jun 2025
- First submitted
- 9 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07422740
- Acronym / sponsor ID
- 2025-0626
- Conditions
- Post-stroke Depression
- Keywords
- Post-stroke depression, Transcranial direct current stimulation, Virtual reality mindfulness-based cognitive therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Hangzhou Seventh People's Hospital, Affiliated Mental Health Center, Zhejiang University School of Medicine
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combined Intervention Group (Active VR-MBCT + Active tDCS) | Experimental | Behavioral: Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT), Device: Active transcranial Direct Current Stimulation (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). |
| VR-MBCT Control Group (Active VR-MBCT + Sham tDCS) | Active comparator | Behavioral: Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT), Device: Sham transcranial Direct Current Stimulation (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). |
| Active tDCS Control Group (Sham VR-MBCT + Active tDCS) | Active comparator | Device: Active transcranial Direct Current Stimulation (Active tDCS), Behavioral: Sham Virtual Reality Mindfulness Program (Sham VR-MBCT)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). |
| Double Control Group (Sham VR-MBCT + Sham tDCS) | Sham comparator | Behavioral: Sham Virtual Reality Mindfulness Program (Sham VR-MBCT), Device: Sham transcranial Direct Current Stimulation (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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT)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. | Behavioural | Combined Intervention Group (Active VR-MBCT + Active tDCS), VR-MBCT Control Group (Active VR-MBCT + Sham tDCS) |
| Active transcranial Direct Current Stimulation (Active tDCS)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. | Device | Active tDCS Control Group (Sham VR-MBCT + Active tDCS), Combined Intervention Group (Active VR-MBCT + Active tDCS) |
| Sham Virtual Reality Mindfulness Program (Sham VR-MBCT)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. | Behavioural | Active tDCS Control Group (Sham VR-MBCT + Active tDCS), Double Control Group (Sham VR-MBCT + Sham tDCS) |
| Sham transcranial Direct Current Stimulation (Sham tDCS)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. | Device | Double Control Group (Sham VR-MBCT + Sham tDCS), VR-MBCT Control Group (Active VR-MBCT + Sham tDCS) |
Primary outcome
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.
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.
11 secondary outcomes
Treatment Retention Rate
Time frame: Week 4
Intervention Adherence Rate
Time frame: Week 4
Change in HAMA Score
Time frame: Baseline, Week 4, Week 8, Week 28
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score
Time frame: Baseline, Week 4, Week 8, Week 28
Change in Five Facet Mindfulness Questionnaire (FFMQ) Score
Time frame: Baseline, Week 4, Week 8, Week 28
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline, Week 4, Week 8, Week 28
Change in Patient Health Questionnaire-15 (PHQ-15) Score
Time frame: Baseline, Week 4, Week 8, Week 28
Change in modified Rankin Scale (mRS) Score
Time frame: Baseline, Week 4, Week 8, Week 28
Change in 36-Item Short Form Health Survey (SF-36) Score
Time frame: Baseline, Week 4, Week 8, Week 28
Change in Hospital Anxiety and Depression Scale (HADS) Score
Time frame: Baseline, Week 4, Week 8, Week 28
Change in resting-state functional connectivity (fMRI)
Time frame: Baseline, Week 4, Week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Mindfulness-Based Cognitive Therapy (Active VR-MBCT) and Active transcranial Direct Current Stimulation (Active tDCS) in people with Post-stroke Depression, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lusha Tong, MD (086+15868171218, 2310040@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.