Non-Suicidal Self-Injury Digital Psychotherapy Trial

The goal of this randomized, parallel‐controlled clinical trial is to investigatemulti‐dimensional biomarkers (blood, brain imaging, clinical information, and symptomassessment) in adolescents with Non‐Suicidal Self‐Injury (NSSI) and to evaluate thetherapeutic and prognostic effects of a novel digital psychological intervention plustreatment as usual (TAU) compared to TAU alone in this population.The main question[s] it aims to answer [is/are]:What are the distinct biomarker profiles (e.g., inflammatory, endocrine, neuroimaging)associated with adolescent NSSI? Does the novel digital psychological intervention (basedon CBT and DBT) combined with TAU lead to a higher clinical response rate (≥25% reductionin NSSI scale score from baseline) at 8 and 16 weeks compared to TAU alone?If there is a comparison group: Researchers will compare the digital intervention plusTAU group to the TAU‐only group to see if adding the digital intervention significantlyimproves NSSI symptom reduction, depressive symptoms (HAMD‐24 response rate), andlong‐term outcomes.Participants will:Undergo baseline assessments including blood sampling (inflammatory and endocrinemarkers, routine biochemistry), structural and resting‐state functional MRI, and clinicalscales (e.g., HAMD, HAMA).Use a smartphone app for 8 weeks, completing 16 self‐guided digital modules (2 per week,15‐25 minutes each) based on CBT and DBT, covering topics such as NSSI psychoeducation,safety planning, emotion regulation, distress tolerance, mindfulness, and relapseprevention.Complete daily Ecological Momentary Assessment (EMA) questionnaires (1‐2 minutes) onself‐harm urge intensity, mood, and coping skills used; receive Ecological MomentaryIntervention (EMI) when high urge is detected.Receive low‐intensity remote coaching (one 20‐30 min onboarding call, then two briefcontacts per week via text/call/email) to support app adherence.Attend follow‐up assessments at week 4, week 8 (intervention endpoint), and week 16(study endpoint) for repeated clinical and outcome measures.