Non-suicidal Self-injury Comorbid with Depressive Disorder
Conditions
Interventions
Control group:In the first stage of the research,tDCS sham stimulation+ VR-TEC sham stimulation
The single VR-TEC treatment group:In the first stage of the research,tDCS sham stimulation + Active VR-TEC
The single tDCS treatment group:In the first stage of the research,Active tDCS + VR-TEC sham stimulation
best single intervention group:The second stage of the research,The effective group was identified by comparing the control group, the single tDCS treatment group and the single VR-TEC treatment group
Combined treatment group:The second stage of the research,Active tDCS + Active VR-TEC
Adaptive Closed-Loop Intervention Group:In the third stage, an adaptive closed-loop neuromodulation intervention was implemented, in which stimulation parameters were dynamically adjusted based on rea
Sponsors
Seventh People's Hospital of Hangzhou
Eligibility
Sex/Gender
All
Age
13 Years to 19 Years
Inclusion criteria
Inclusion criteria: 1) Right-handed Chinese people of both sexes aged 13 to 19 years who met the Diagnostic and Statistical Manual ofMental Disorders (DSM-5) criteria, The patient was clinically diagnosed with MDD. The Chinese version of (StructuredClinical Interview for DSM-5 (SCID-5) was used to confirm the diagnosis. 2) At least 5 episodes of NSSI in the past year (at least one NSSI in the past month), at least moderately severe depressive episodes, and baseline 17-item Hamilton Depression Scale (HDRS-17) >=17; 3) There was no specific restriction on baseline medication, which was in line with clinical routine diagnosis and treatment standards; 4) No contraindications to tDCS (such as metal plates in the head, brain implants, cerebral aneurysm clips, cochlear implants, cardiac pacemakers, etc.); 5) Have not received systemic psychotherapy such as MBCT, mindfulness training, or cognitive behavioral therapy for current or previous depressive episode; 6) At least 8 years of formal education experience; 7) Have not received tDCS or other transcranial electrical stimulation for current or previous depressive episode; 8) Meet the indications for MRI and Meg data acquisition; 9) Patients understood and complied with the requirements of the study, as judged by the investigator.
Exclusion criteria
Exclusion criteria: 1) Treatment-resistant depression (TRD), defined as refractory to at least two previous antidepressants with different mechanisms of action despite adequate treatment (maximum recommended therapeutic dose for at least 8 weeks); 2) Other psychiatric diagnoses (e.g., mental retardation, schizophrenia, schizoaffective disorder, bipolar disorder, obsessive-compulsive disorder, attention deficit hyperactivity disorder, eating disorder, personality disorder, substance use disorder, post-traumatic stress disorder, panic disorder or social phobia), but anxiety disorder as a comorbidity is acceptable; 3) Current use of drugs that may severely affect cortical excitability (e.g., benzodiazepines, antiepileptic drugs, etc.); 4) Suicidal planning or behavior within 4 weeks before baseline; 5) Depressive symptoms are better explained by other clinical conditions (e.g., hypothyroidism, anemia, congestive heart failure, etc.) or other psychiatric disorders; 6) Accompanied by serious and unstable cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, malignant tumor and other physical diseases; 7) Significant impairment of liver and kidney function or other serious physical illness and metabolic disorders as shown by laboratory tests, screening or baseline total bilirubin (TBIL) value greater than 1.5 times the upper limit of normal, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value greater than 3 times the upper limit of normal; Or glomerular filtration rate (GFR) =70mL/min, or thyroid stimulating hormone (TSH) beyond the normal range; 8) Hypertensive subjects with poorly controlled blood pressure (screening or baseline sitting systolic blood pressure (SBP)>=140mmHg or sitting diastolic blood pressure (DBP)>=90mmmHg); 9) Epilepsy and/or other neurological conditions (e.g. stroke, dementia, traumatic brain injury, Parkinson's disease, Huntington's disease, multiple sclerosis), and any neurological conditions that cause increased intracranial pressure, brain damage or increase the risk of seizures; 10) Have vision or hearing impairment that cannot be assessed by the intervention or questionnaire; 11) Received brain stimulation therapy (such as electroconvulsion therapy (ECT), modified electroconvulsion therapy (mECT), transcranial magnetic stimulation (TMS), repetitive transcranial magnetic stimulation (rTMS), deep brain stimulation, vagus nerve stimulation, etc.) within 3 months before baseline; 12) Participated in other clinical trials within 1 month before baseline (except unqualified for screening); 13) Other circumstances that the participant was judged by the investigator to be ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in OSI score at different time points;DSHI scores;DSHI-AR scores;magnetoencephalography; | — |
Secondary
| Measure | Time frame |
|---|---|
| SHAPS scores;GAF scores;FFMQ scores;SDS scores;HAMA scores;CGI scores;PHQ-9 scores;RRS scores;PSQI scores;Multi-source multi-modal brain image structure and functional neuroimaging (high-resolution brain structure MRI, DTI, Rs-fMRI, task-state fMRI); | — |
Countries
China
Contacts
Public ContactWanjun Guo
Affiliated Mental Health Centre & Hangzhou Seventh People’s Hospital
Outcome results
None listed