Non-Suicidal Self-Injury Digital Psychotherapy Trial (NSSI-DPT)
A Novel Digital Psychotherapy Intervention for Non-Suicidal Self-Injury in Adolescents: A Randomized Controlled 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: digital psychological intervention group
Participants in the experimental group will receive the novel digital psychological intervention plus treatment as usual (TAU). The digital intervention is delivered via a smartphone app over 8 weeks and includes: 16 self-guided modules (2 per week, 15-25 minutes each) based on cognitive behavioral therapy (CBT) and dialectical behavior therapy (DBT), covering NSSI psychoeducation, emotion regulation, distress tolerance, mindfulness, safety planning, and relapse prevention. Daily ecological momentary assessment (EMA) of mood and self-harm urges, with automated ecological momentary intervention (EMI) triggered when high urges are detected. Low-intensity remote coaching (one onboarding call and two brief weekly contacts) to support adherence. |
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. |
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Comparador Ativo: treatment as usual
TAU is provided as per standard clinical practice at the study site.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Clinical Response Rate
Prazo: At week 8 (intervention endpoint) and week 16 (study endpoint)
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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.
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At week 8 (intervention endpoint) and week 16 (study endpoint)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Depressive Symptom Response Rate
Prazo: At week 8 and week 16
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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.
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At week 8 and week 16
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Colaboradores e Investigadores
Datas de registro do estudo
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Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- KY-2026-051
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