Not Yet RecruitingNot Applicable

Non-Suicidal Self-Injury Digital Psychotherapy Trial

110 participantsStarted 2026-06-15

Plain-language summary

The goal of this randomized, parallel-controlled clinical trial is to investigate multi-dimensional biomarkers (blood, brain imaging, clinical information, and symptom assessment) in adolescents with Non-Suicidal Self-Injury (NSSI) and to evaluate the therapeutic and prognostic effects of a novel digital psychological intervention plus treatment 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 (based on CBT and DBT) combined with TAU lead to a higher clinical response rate (≥25% reduction in 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 plus TAU group to the TAU-only group to see if adding the digital intervention significantly improves NSSI symptom reduction, depressive symptoms (HAMD-24 response rate), and long-term outcomes. Participants will: Undergo baseline assessments including blood sampling (inflammatory and endocrine markers, routine biochemistry), structural and resting-state functional MRI, and clinical scales (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 relapse prevention. Complete daily Ecological Momentary Assessment (EMA) questionnaires (1-2 minutes) on self-harm urge intensity, mood, and coping skills used; receive Ecological Momentary Intervention (EMI) when high urge is detected. Receive low-intensity remote coaching (one 20-30 min onboarding call, then two brief contacts 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.

Who can participate

Age range

12 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of Non-Suicidal Self-Injury (NSSI) according to DSM-5, confirmed by two psychiatrists with senior professional titles. * Adolescents aged 12-25 years, any gender. * Willing to participate voluntarily and with good insight. Exclusion Criteria: * Presence of severe mental disorders (e.g., schizophrenia, schizoaffective disorder, substance use disorder, intellectual disability). * Major central nervous system diseases (e.g., history of head trauma or infection, intracranial tumor, cerebrovascular disease, epilepsy). * History of major physical diseases (e.g., malignancy, myocardial infarction, liver or kidney dysfunction). * History of abuse of sedative-hypnotics, alcohol, or other psychoactive substances. * History of suicide attempt, current high suicide risk, or current suicidal behavior/ideation. * Pregnancy or breastfeeding.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Response Rate

Timeframe: At week 8 (intervention endpoint) and week 16 (study endpoint)

Trial details

NCT IDNCT07683234

SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-15

View on ClinicalTrials.gov More Non-suicidal Self-injury (NSSI) trials