[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658267":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":47,"studyPopulation":42,"armGroups":48,"interventions":57,"overallOfficials":63,"centralContacts":67,"locations":42,"responsibleParty":73,"collaborators":76,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":42,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":42,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":105,"whyStopped":42,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":42},{"fullName":5,"class":6},"Central China Normal University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Severity of non-suicidal self-injury behaviors","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.",[14,17],{"measure":15,"description":16,"timeFrame":12},"Depression","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.",{"measure":18,"description":19,"timeFrame":12},"Anxiety","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.",[21,24,27,30,33],{"measure":22,"description":23,"timeFrame":12},"Psychological flexibility","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.\n\nPF 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.",{"measure":25,"description":26,"timeFrame":12},"Hope","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.",{"measure":28,"description":29,"timeFrame":12},"Emotion Regulation Strategies","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).",{"measure":31,"description":32,"timeFrame":12},"Functions of Non-Suicidal Self-Injury","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).",{"measure":34,"description":35,"timeFrame":36},"Client Satisfaction","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).",{"allocation":38,"interventionModel":39,"interventionModelDescription":40,"primaryPurpose":41,"observationalModel":42,"timePerspective":42,"maskingInfo":43},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to either the intervention group (ACT-based chatbot) or the waitlist control group. Both groups will be assessed at baseline, post-intervention, and follow-up. Participants in the waitlist control group will receive the same intervention after the study period ends.","TREATMENT",null,{"masking":44,"maskingDescription":42,"whoMasked":45},"SINGLE",[46],"OUTCOMES_ASSESSOR","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.\n\nObjective: This randomized controlled trial aims to examine the efficacy of an ACT-based chatbot in reducing NSSI among adolescents.\n\nMethods: 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.\n\nAnalysis: Intention-to-treat analysis will be used. Mixed-effects models will assess changes over time between groups.",[49,54],{"label":50,"type":51,"description":42,"interventionNames":52},"\"ACT-Based Chatbot\" Group","EXPERIMENTAL",[53],"Behavioral: ACT-Based Chatbot",{"label":55,"type":56,"description":42,"interventionNames":42},"Control group","NO_INTERVENTION",[58],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":42},"BEHAVIORAL","ACT-Based Chatbot","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.\n\nThe 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.\n\nThe intervention is designed to be self-guided, with no human therapist involvement, to ensure scalability and accessibility.",[50],[64],{"name":65,"affiliation":5,"role":66},"Zhihong Ren, PhD","PRINCIPAL_INVESTIGATOR",[68],{"name":69,"role":70,"phone":71,"phoneExt":42,"email":72},"Jiaojiao Jia","CONTACT","China code +86 15308622827","jiajiaojiao@mails.ccnu.edu.cn",{"type":66,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Zhihong Ren","Professor and Vice Dean",[77],{"name":78,"class":6},"Wuhan Mental Health Centre","100658267","acceptance-and-commitment-therapy-based-chatbot-for-non-suicidal-self-injury-in-adolescents-100658267",false,"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","Inclusion Criteria:\n\n* Be adolescents aged 10-19 years (Sawyer et al., 2018).\n* 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).\n* Provide assent to participate, with written informed consent obtained from both the adolescent and their legal guardian.\n* 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.\n\nExclusion Criteria:\n\n* Have an intellectual disability or other significant cognitive, neurodevelopmental, or visual impairment that may interfere with their ability to complete the study procedures.\n* Have a severe physical illness.\n* Be experiencing an acute episode of a severe mental disorder, such as a manic episode of bipolar disorder.\n* Have experienced suicidal ideation or a suicide attempt within the past month.\n* Do not have access to a smartphone or are unable to use one to complete the study procedures.","ALL","10 Years","19 Years",{"count":90,"type":91},100,"ESTIMATED","INTERVENTIONAL",[94],"NA","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.",[97],"Non-suicidal Self-injury (NSSI)",[99,100,101,102,103,104],"Internet-Based Intervention","Chatbot","Randomized Controlled Trial","Non-suicidal self-injury (NSSI)","adolescent","Acceptance and commitment therapy","NOT_YET_RECRUITING","2026-09-23",{"date":108,"type":109},"2026-09-30","ACTUAL",{"date":111,"type":91},"2026-10-08",{"date":113,"type":91},"2027-03-01",{"name":5,"class":6}]