Non-Suicidal Self-Injury Digital Psychotherapy Trial

N/ANot Yet RecruitingNCT07683234

The Fourth Affiliated Hospital of Zhejiang University School of Medicine110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

digital psychotherapyBEHAVIORAL

The experimental intervention is an 8-week, self-guided digital psychological intervention delivered via a smartphone application, added to treatment as usual (TAU). It is based on cognitive behavioral therapy (CBT) and dialectical behavior therapy (DBT). The intervention includes: 16 interactive modules (2 per week, 15-25 minutes each) covering NSSI psychoeducation, safety planning, emotion regulation, distress tolerance, mindfulness, interpersonal effectiveness, and relapse prevention. Daily ecological momentary assessment (EMA) of mood and self-harm urges (1-2 minutes/day). Automated ecological momentary intervention (EMI) triggered when high-intensity urges are reported, providing real-time coping skills and safety plan access. Digital safety plan and skill-logging features. Low-intensity remote coaching (one 20-30 minute onboarding call, then two brief contacts per week via text/phone/email) to support app adherence.

Treatment as Usual (TAU)DRUG

Treatment as usual (TAU) consists of standard clinical care provided at the Department of Psychiatry, The Fourth Affiliated Hospital, Zhejiang University School of Medicine. TAU may include medication management (e.g., antidepressants or mood stabilizers as clinically indicated), routine psychiatric follow-up visits, supportive counseling, and any other non-experimental interventions prescribed by the treating psychiatrist. No additional digital psychological intervention is given. Participants in the TAU-alone group do not have access to the study app but will undergo the same assessment schedule (baseline, week 4, week 8, week 16) as the experimental group.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 25 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Clinical Response Rate

Proportion of participants with a ≥25% reduction from baseline in the Non-Suicidal Self-Injury (NSSI) scale score. The NSSI scale has a total score ranging from 0 to 124, with higher scores indicating greater severity of NSSI behaviors.

Time frame: At week 8 (intervention endpoint) and week 16 (study endpoint)

Secondary Outcomes

Depressive Symptom Response Rate

Proportion of participants with a ≥25% reduction from baseline in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score. The HAMD-24 scale has a total score ranging from 0 to 74, with higher scores indicating greater severity of depression.

Time frame: At week 8 and week 16