[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-suicidal-self-injury-nssi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-suicidal-self-injury-nssi":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,78,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100648201","group-treatment-for-self-harming-adolescents-and-their-parents-a-randomized-controlled-trial-100648201",false,"NCT07720063","Group Treatment for Self-harming Adolescents and Their Parents: a Randomized Controlled Trial","A Randomised Controlled Trial of Group Emotion Regulation for Adolescent Self-harm (the ERA-study)","ERA","Inclusion Criteria:\n\n* Age: 13 - 17 years\n* At least 5 instances of NSSI in the past year, and at least one during the past month\n* ≥5 episodes of NSSI in the past year, including ≥1 in the past month\n* If receiving antidepressant, central stimulants or neuroleptic medication, dose must be stable for least 6 weeks prior to inclusion\n* At least one participating caregiver\n* Sufficient Swedish language proficiency (adolescent and caregiver)\n* Regular access to a smartphone for SMS-based assessment\n\nExclusion Criteria:\n\n* Intellectual disability or a severe psychiatric disorder requiring immediate treatment (e.g., psychosis, bipolar disorder type 1, anorexia nervosa, alcohol\u002Fsubstance dependence) or conditions that prevent participation (e.g., severe social anxiety, selective mutism)\n* Acute suicide risk (i.e., current suicide plans) or recent suicide attempt\n* Previous or ongoing structured emotion regulation treatment involving at least 3 sessions during the past 12 months\n* Previous or ongoing structured emotion regulation treatment (≥3 sessions within past 12 months)\n* Social circumstances preventing participation or require immediate action (e.g., domestic violence, abuse and\u002For neglect in the family, inpatient care)\n* Ongoing structured psychological treatment targeting NSSI","ALL","13 Years","17 Years",{"count":21,"type":22},180,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.\n\nThe 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.",[28,29,30,31,32],"Self-Harm","Self-Harm, Deliberate","Self-harm Behavior","Non-Suicidal Self Injury","Non-suicidal Self-injury (NSSI)",[34,35,36],"emotion regulation group therapy","non-suicidal self-injury (NSSI)","randomized controlled trial","NOT_YET_RECRUITING","2026-08-17",{"date":40,"type":41},"2026-08-18","ACTUAL",{"date":38,"type":22},{"date":44,"type":22},"2034-12-31",{"name":46,"class":47},"Karolinska Institutet","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100647065","non-suicidal-self-injury-digital-psychotherapy-trial-100647065","NCT07683234","Non-Suicidal Self-Injury Digital Psychotherapy Trial","A Novel Digital Psychotherapy Intervention for Non-Suicidal Self-Injury in Adolescents: A Randomized Controlled Trial","NSSI-DPT","Inclusion Criteria:\n\n* Diagnosis of Non-Suicidal Self-Injury (NSSI) according to DSM-5, confirmed by two psychiatrists with senior professional titles.\n* Adolescents aged 12-25 years, any gender.\n* Willing to participate voluntarily and with good insight.\n\nExclusion Criteria:\n\n* Presence of severe mental disorders (e.g., schizophrenia, schizoaffective disorder, substance use disorder, intellectual disability).\n* Major central nervous system diseases (e.g., history of head trauma or infection, intracranial tumor, cerebrovascular disease, epilepsy).\n* History of major physical diseases (e.g., malignancy, myocardial infarction, liver or kidney dysfunction).\n* History of abuse of sedative-hypnotics, alcohol, or other psychoactive substances.\n* History of suicide attempt, current high suicide risk, or current suicidal behavior\u002Fideation.\n* Pregnancy or breastfeeding.","12 Years","25 Years",{"count":59,"type":22},110,[25],"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.\n\nThe main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\nWhat 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?\n\nIf 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.\n\nParticipants will:\n\nUndergo baseline assessments including blood sampling (inflammatory and endocrine markers, routine biochemistry), structural and resting-state functional MRI, and clinical scales (e.g., HAMD, HAMA).\n\nUse 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.\n\nComplete 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.\n\nReceive low-intensity remote coaching (one 20-30 min onboarding call, then two brief contacts per week via text\u002Fcall\u002Femail) to support app adherence.\n\nAttend follow-up assessments at week 4, week 8 (intervention endpoint), and week 16 (study endpoint) for repeated clinical and outcome measures.",[32],[64,65,66,67,68],"Non-Suicidal Self-Injury (NSSI)","adolescents","digital psychological intervention","randomized controlled trial (RCT)","dialectical behavior therapy (DBT)","2026-06-28",{"date":71,"type":41},"2026-07-06",{"date":73,"type":22},"2026-06-15",{"date":75,"type":22},"2028-12-31",{"name":77,"class":47},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":19,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100601414","blended-unified-protocol-for-chinese-adolescents-with-non-suicidal-self-injury-a-randomized-controlled-trial-100601414","NCT07110181","Blended Unified Protocol for Chinese Adolescents With Non-Suicidal Self-Injury: A Randomized Controlled Trial","A Randomized Controlled Trial Evaluating the Efficacy of a Blended Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Chinese Adolescents With Non-Suicidal Self-Injury","Inclusion Criteria:\n\n1. Aged between 12 and 17 years;\n2. Engaged in non-suicidal self-injury (NSSI) at least 5 times in the past 12 months, with at least 1 episode in the past month;\n3. Minimum education level of primary school or above;\n4. Participant and guardian fully understand the research content and agree to participate, with signed informed consent provided.\n\nExclusion Criteria:\n\n1. Suicide attempts in the past month or a score of ≥17 on the MINI National Neuropsychiatric Interview for Children (MINI KID 5.0), indicating a high risk of suicide;\n2. Diagnosis of a psychotic disorder, autism spectrum disorder, or other serious neurodevelopmental disorders according to the DSM-5;\n3. Presence of severe physical illness or other medical conditions that may affect the completion of treatment and evaluation;\n4. Currently receiving other professional psychotherapy or participating in another NSSI intervention study;\n5. Received 5 or more sessions of cognitive behavioral therapy (CBT) in the past 5 years;\n6. Having received electroconvulsive therapy (ECT) within the past 6 months.",{"count":86,"type":22},60,[25],"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.",[32],[91,92],"non-suicidal self-injury","adolescent","2025-07-31",{"date":95,"type":41},"2025-08-07",{"date":97,"type":22},"2025-08-15",{"date":99,"type":22},"2026-06-20",{"name":101,"class":47},"Jian-Jun Ou",1,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":19,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":115,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":102},"100582071","blended-unified-protocol-in-chinese-adolescents-with-non-suicidal-self-injury-100582071","NCT06858540","Blended Unified Protocol in Chinese Adolescents With Non-Suicidal Self-Injury","A Blended Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Chinese Adolescents With Non-suicidal Self-injury: A Pilot Study","Inclusion Criteria:\n\n1. Aged between 12 and 17 years;\n2. Engaged in non-suicidal self-injury (NSSI) at least 5 times in the past 12 months, with at least 1 episode in the past month;\n3. Minimum education level of primary school or above;\n4. Participant and guardian fully understand the research content and agree to participate, with signed informed consent provided.\n\nExclusion Criteria:\n\n1. Suicide attempts in the past month or a score of ≥17 on the MINI National Neuropsychiatric Interview for Children (MINI KID 5.0), indicating a high risk of suicide;\n2. Diagnosis of a psychotic disorder, manic or hypomanic episode, autism spectrum disorder, or other serious neurodevelopmental disorders according to the DSM-5;\n3. Presence of severe physical illness or other medical conditions that may affect the completion of treatment and evaluation;\n4. Currently receiving other professional psychotherapy or participating in another NSSI intervention study;\n5. Received 5 or more sessions of cognitive behavioral therapy (CBT) in the past 5 years;\n6. Having received electroconvulsive therapy (ECT) within the past 6 months.",{"count":111,"type":22},12,[25],"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.",[32],"RECRUITING","2025-05-02",{"date":118,"type":41},"2025-05-04",{"date":120,"type":41},"2025-04-29",{"date":122,"type":22},"2025-10-30",{"name":101,"class":47}]