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- Ensaio Clínico NCT07848620
Acceptance and Commitment Therapy-Based Chatbot for Non-suicidal Self-Injury in Adolescents
Acceptance and Commitment Therapy-Based Chatbot for Non-suicidal Self-Injury in Adolescents: A Randomized Controlled Trial
The purpose of this study is to evaluate the feasibility and effectiveness of a self-guided digital Acceptance and Commitment Therapy (ACT) intervention for adolescents who engage in non-suicidal self-injury (NSSI). The intervention is delivered through a mobile-based program and consists of seven modules focusing on acceptance, cognitive defusion, present-moment awareness, self-as-context, values, and committed action. Adolescents will complete the intervention over a 3-week period and will be randomly assigned to the intervention or control condition. The study will examine whether the digital ACT intervention can reduce NSSI and improve psychological flexibility and other indicators of mental health, including depression, anxiety, hope, and emotion regulation.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Background: Nonsuicidal self-injury (NSSI) is highly prevalent among adolescents. Acceptance and Commitment Therapy (ACT) has shown promise, but access to traditional therapy is limited. Chatbot-based interventions offer a scalable alternative.
Objective: This randomized controlled trial aims to examine the efficacy of an ACT-based chatbot in reducing NSSI among adolescents.
Methods: Participants will be randomized 1:1 to the intervention group (ACT-based chatbot) or a waitlist control group. The intervention lasts three weeks, with modules covering acceptance, cognitive defusion, values, and committed action. Assessments will be conducted at baseline, post-intervention, 1-month and 3-months follow-up. Primary outcome is the frequency of NSSI episodes. Secondary outcomes include NSSI severity,anxiety symptoms and depressive symptoms.
Analysis: Intention-to-treat analysis will be used. Mixed-effects models will assess changes over time between groups.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Jiaojiao Jia
- Número de telefone: China code +86 15308622827
- E-mail: jiajiaojiao@mails.ccnu.edu.cn
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Be adolescents aged 10-19 years (Sawyer et al., 2018).
- Have engaged in five or more self-injurious behaviors within the past year and meet the DSM-5 diagnostic criteria for Non-Suicidal Self-Injury (NSSI) (American Psychiatric Association, 2013).
- Provide assent to participate, with written informed consent obtained from both the adolescent and their legal guardian.
- Have access to a smartphone capable of completing the study procedures, including logging into the study mini-program to complete the self-guided intervention and sending and receiving text messages.
Exclusion Criteria:
- Have an intellectual disability or other significant cognitive, neurodevelopmental, or visual impairment that may interfere with their ability to complete the study procedures.
- Have a severe physical illness.
- Be experiencing an acute episode of a severe mental disorder, such as a manic episode of bipolar disorder.
- Have experienced suicidal ideation or a suicide attempt within the past month.
- Do not have access to a smartphone or are unable to use one to complete the study procedures.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Grupo de controle
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Experimental: "ACT-Based Chatbot" Group
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The intervention is a fully automated, text-based chatbot delivered via a mobile application or web platform. It is based on the core processes of Acceptance and Commitment Therapy (ACT). Over three weeks, participants will engage with the chatbot for approximately 10 minutes per day, 3 days per week. The chatbot delivers structured modules covering: (1) acceptance and willingness to experience difficult emotions; (2) cognitive defusion techniques; (3) present-moment awareness; (4) self-as-context; (5) values clarification; and (6) committed action. The chatbot includes safety protocols that provide crisis resources and emergency contact information if participants report severe self-harm urges or suicidal ideation. The intervention is designed to be self-guided, with no human therapist involvement, to ensure scalability and accessibility. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Severity of non-suicidal self-injury behaviors
Prazo: The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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The Behavior subscale of the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ) will be used to assess adolescents' non-suicidal self-injury behaviors and functions. The Behavior subscale consists of 12 items, rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). |
The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Depression
Prazo: The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depressive symptoms. The questionnaire consists of nine items, each rated from 0 to 3. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. |
The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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Anxiety
Prazo: The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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The Generalized Anxiety Disorder-7 (GAD-7) will be used to assess anxiety symptoms. The scale consists of seven items rated on a 4-point scale: 0 (not at all), 1 (several days), 2 (more than half the days), and 3 (nearly every day). Total scores range from 0 to 21, with higher scores indicating greater severity of anxiety symptoms. |
The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Psychological flexibility
Prazo: The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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The 24-item Multidimensional Psychological Flexibility Inventory (MPFI-24) will be used to measure psychological flexibility. The MPFI-24 assesses two broad domains: psychological flexibility (PF) and psychological inflexibility (PI), comprising 24 items in total. Items are rated on a 6-point scale. PF includes six processes: contact with the present moment, acceptance, cognitive defusion, self-as-context, committed action, and values. PI includes six processes: lack of contact with the present moment, experiential avoidance, cognitive fusion, self-as-content, inaction, and lack of contact with values. |
The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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Hope
Prazo: The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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The Children's Hope Scale (CHS) will be used to assess adolescents' goal-related cognitive tendencies, including agency thinking and pathways thinking. The scale consists of six items across two dimensions. Items are rated on a 6-point Likert scale ranging from 1 (never) to 6 (always), with higher scores indicating higher levels of hope. |
The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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Emotion Regulation Strategies
Prazo: The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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The Regulatory Emotional Self-Efficacy Scale (RES) will be used to assess adolescents' perceived self-efficacy in regulating their emotions. The scale consists of 12 items across three dimensions. Items are rated on a 5-point scale ranging from 1 (strongly inconsistent with me) to 5 (strongly consistent with me). |
The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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Functions of Non-Suicidal Self-Injury
Prazo: The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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The Function subscale of the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ) will be used to assess the functions underlying adolescents' NSSI. The Function subscale consists of 19 items, rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). |
The assessment time points will be: baseline, immediately after the third intervention module, immediately after the sixth intervention module (post-intervention), 1-month follow-up after intervention completion, and 3-month follow-up after intervention.
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Client Satisfaction
Prazo: This measure will be administered immediately after the sixth intervention module (post-intervention).
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The Client Satisfaction Questionnaire (CSQ-8) will be used to measure clients' satisfaction with psychological interventions. It consists of 8 items rated on a 4-point scale ranging from 1 to 4, with higher scores indicating greater satisfaction. |
This measure will be administered immediately after the sixth intervention module (post-intervention).
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Zhihong Ren, PhD, Central China Normal University
Publicações e links úteis
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CCNU-IRB-202603054A
- 2024YFC3308400 (Número de outro subsídio/financiamento: National Key R&D Program of China)
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- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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