Non-suicidal Self-injury (NSSI)

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Review clinical trials related to Non-suicidal Self-injury (NSSI). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Group Treatment for Self-harming Adolescents and Their Parents: a Randomized Controlled Trial

Adolescent non-suicidal self-injury (NSSI) is common, strongly associated with psychiatric comorbidity and an increased risk of future suicide attempt. Although interventions targeting emotion regulation have been shown to reduce NSSI in both adults and adolescents few, are available within routine child and adolescent mental health services (CAMHS). Emotion Regulation for Adolescents (ERA), adapted from an evidence-based adult intervention is a brief group-based treatment designed to increase access to effective, evidence-based care for adolescents with NSSI. A large-scale randomised controlled trial (RCT) is needed to establish its efficacy and strengthen the evidence base for emotion regulation interventions for adolescent NSSI. The overall aim of this project is to increase the availability of evidence-based psychological treatments for adolescent NSSI by developing and evaluating Emotion Regulation for Adolescents (ERA), a novel behavioural and acceptance-based intervention. The main objectives are to establish the efficacy, cost-effectiveness, and long-term outcomes of ERA for adolesent NSSI in two arm RCT comparing ERA with an active control condition (FUNK) as well as to investigate potential mediators such as emotion regulation and self-criticism.

Participants needed: 180
Trial details
Age: 13-17Biological sex: AllType: InterventionalSponsor: Karolinska InstitutetUpdated: Aug 18, 2026
Eligibility criteria

Age: 13 - 17 years [+6]

Intellectual disability or a severe psychiatric disorder requiring immediate tre... [+5]

Status: Not yet recruiting

Non-Suicidal Self-Injury Digital Psychotherapy Trial

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.

Participants needed: 110
Trial details
Age: 12-25Biological sex: AllType: InterventionalSponsor: The Fourth Affiliated Hospital of Zhejiang University School of MedicineUpdated: Jul 6, 2026
Eligibility criteria

Diagnosis of Non-Suicidal Self-Injury (NSSI) according to DSM-5, confirmed by tw... [+2]

Presence of severe mental disorders (e.g., schizophrenia, schizoaffective disord... [+5]

Status: Not yet recruiting

Blended Unified Protocol for Chinese Adolescents With Non-Suicidal Self-Injury: A Randomized Controlled Trial

This study is an open-label, randomized controlled trial evaluating the efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) in reducing non-suicidal self-injury (NSSI) among Chinese adolescents. This program is an annualized cognitive-behavioral therapy designed for adolescents aged 12-17 years who engage in non-suicidal self-injury behavior. Its primary goal is to reduce the intensity and frequency of distressing emotional experiences by teaching adolescents how to confront and respond to these emotions in more adaptive ways. In turn, this helps reduce self-injury impulses and behaviors. The UP-A is adapted to the Chinese cultural context and delivered as a blended treatment, combining face-to-face and online sessions.

Participants needed: 60
Trial details
Age: 12-17Biological sex: AllType: InterventionalSponsor: Jian-Jun OuUpdated: Aug 7, 2025Locations: 1
Eligibility criteria

Aged between 12 and 17 years; [+3]

Suicide attempts in the past month or a score of ≥17 on the MINI National Neurop... [+5]

Status: Recruiting

Blended Unified Protocol in Chinese Adolescents With Non-Suicidal Self-Injury

This study utilizes the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) to address non-suicidal self-injury among Chinese adolescents. This program is an annualized cognitive-behavioral therapy designed for adolescents aged 12-17 years who engage in non-suicidal self-injury behavior. Its primary goal is to reduce the intensity and frequency of distressing emotional experiences by teaching adolescents how to confront and respond to these emotions in more adaptive ways. In turn, this helps reduce self-injury impulses and behaviors. The UP-A is adapted to the Chinese cultural context and delivered as a blended treatment, combining face-to-face and online sessions. The study will assess the feasibility, acceptability, and preliminary efficacy of this intervention through a single-arm design, which includes pretest, posttest, and follow-up assessments.

Participants needed: 12
Trial details
Age: 12-17Biological sex: AllType: InterventionalSponsor: Jian-Jun OuUpdated: May 4, 2025Locations: 1
Eligibility criteria

Aged between 12 and 17 years; [+3]

Suicide attempts in the past month or a score of ≥17 on the MINI National Neurop... [+5]