Non-Suicidal Self-Injury (NSSI)
Conditions
Interventions
Intervention group:Self-developed ear electrodes deliver electrical stimulation to the concha cavity region where the vagus nerve is distributed, alongside online psychological intervention courses
Control group:Self-developed ear electrodes deliver electrical stimulation to non-vagal nerve distribution sites alongside online psychological intervention courses
Sponsors
Tsinghua University
Eligibility
Sex/Gender
All
Age
10 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age 10 to 18 years; 2. Right-handed individuals; 3. Voluntarily participating in the research, and signing the informed consent form jointly by the participant and at least one parent; 4. Willingness to be audio or video recorded during the intervention; 5. Meets diagnostic criteria for Major Depressive Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and is currently experiencing a depressive episode; 6.Beck Depression Inventory-II (BDI-II) score >=13; 7. In the past month at least once, and in the past year at least five days, there have been behaviors of attempting to intentionally harm oneself but not wanting to die; 8. At enrolment, patients must meet the following medication status: either not currently taking any medication, or receiving stable-dose antidepressant treatment limited to selective serotonin reuptake inhibitors (SSRIs). "Stable" is defined as no adjustments to antidepressant medication for at least four weeks prior to enrolment. The use of antidepressants other than SSRIs, mood stabilizers, or antipsychotic medications is prohibited throughout the trial period. Following completion of the intervention and outcome assessments, medication adjustments may be made during the follow-up phase based on clinical necessity, with all changes documented in detail. 9. The subject agrees to attend regular consultations with a psychiatrist and to adhere to the safety/suicide risk management protocol to mitigate suicide risk during the study period.
Exclusion criteria
Exclusion criteria: 1. Patients who, within the three months preceding signing the informed consent form, have been hospitalised due to posing a danger to themselves or others, or have been clinically assessed as "high-risk"—meeting any of the following criteria—or who answered "yes" to items 4, 5, or 6 on the Columbia Suicide Severity Rating Scale (C-SSRS) triage and risk identification screening form shall be excluded: (1) A medically intervened suicide attempt within the past 6 months;( 2) Manifest suicidal intent or an active suicide plan;( 3) Suicidal ideation where family members cannot ensure adequate safety monitoring of the participant during the programme. 2. Individuals previously diagnosed with the following conditions shall be excluded:( 1) History of psychotic disorders, including schizophrenia or depressive episodes with psychotic features;( 2) Neurological systemic diseases; (3) Neurodevelopmental disorders, such as intellectual disability, Asperger syndrome, autism spectrum disorder;( 4) History of substance or medication abuse; (5) Bipolar disorder; (6) Eating disorders; (7.)Obsessive-compulsive disorder;( 8) Post-traumatic stress disorder;( 9) Oppositional defiant disorder, conduct disorder. 3. Exclude patients with treatment-resistant depression, defined as inadequate clinical response to two or more adequate trials of antidepressants at sufficient dose and duration. 4. Exclude individuals with contraindications to transcutaneous vagus nerve stimulation, such as: those with implanted cardiac pacemakers, implanted deep brain stimulators, external ear defects, ulcerations, or skin allergies. 5. Exclude unstable medical conditions, including: (1) Haematological or infectious diseases;( 2)History of autoimmune, endocrine, viral, or vascular disorders;( 3)Unstable cardiac disease, uncontrolled hypertension, or sleep apnoea; (4) Anticoagulant therapy, immunosuppressive therapy, and/or chemotherapy within 3 months prior to study enrolment. 6. Exclusion of exposure to any neuromodulation techniques within the preceding six months, such as electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), or deep brain stimulation (DBS). 7. Exclusion of systemic mental health treatment (including psychotherapy or counselling) within the preceding six months. 8. Exclude participants unwilling to permit audio or video recording during the intervention. 9. Exclude participants refusing to sign the informed consent form, unwilling to participate in this project, or unwilling to have their parents informed and sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of Non-Suicidal Self-Injury (NSSI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Non-Suicidal Self-Injury (NSSI) Ideation;Intensity of NSSI Urge;Readiness to Change NSSI Behavior;Likelihood of Future Non-Suicidal Self-Injury (NSSI);Desire to Stop Non-Suicidal Self-Injury (NSSI);Intensity of NSSI Craving;Functions of Non-Suicidal Self-Injury (NSSI);Severity of Self-Injury Stigma;suicide risk;Severity of Anxiety Symptoms;Severity of Depressive Symptoms;Use of Emotion Regulation Strategies;Interoceptive Awareness;Frequency of Non-Suicidal Self-Injury (NSSI); | — |
Countries
China
Contacts
Public ContactRunsen Chen
Vanke School of Public Health , Tsinghua University
Outcome results
None listed