Clinical Research Directory

Efficacy of Triple-daily 15mA tACS on Adolescent NSSI

This study aims to evaluate the clinical effectiveness of triple-daily 15 mA tACS stimulation in adolescents with Nonsuicidal Self-Injury (NSSI) by comparing the outcomes of active versus sham tACS interventions. Participants will be randomly assigned to either the active or sham tACS group. The trial includes a seven-day intervention phase, during which participants receive treatment three times daily, followed by a four-week observation period. The primary hypothesis is that triple-daily 15 mA tACS will significantly reduce both the severity and frequency of self-injurious behaviors compared with sham stimulation. The study's overall goal is to provide evidence for an effective intervention to help adolescents manage and reduce NSSI behaviors.

Neurobiological Markers of Non-suicidal Self-injury and Treatment Mechanisms of Adolescent Self-injury Intervention Skills Training

The goal of this clinical trial is to evaluate the effectiveness and safety of Adolescent Self-Injury Intervention Skills Training (ASIST), a treatment program developed by the research team, compared with treatment as usual (TAU) in adolescents who engage in non-suicidal self-injury (NSSI). The main questions it aims to answer are: 1. How do the effectiveness and safety of ASIST compare with those of treatment as usual in adolescents with NSSI? 2. How are treatment-related changes in psychological, clinical, behavioral, and biological measures associated with treatment response? 3. Can machine learning techniques be used to predict treatment responses in adolescents with NSSI? Researchers will compare adolescents receiving ASIST with those receiving TAU to examine changes in psychological, clinical, and behavioral characteristics before and after treatment. They will also examine changes in cortisol and beta-endorphin levels, as well as brain activity and functional connectivity during task performance, to explore potential mechanisms associated with treatment response. Participants will: 1. Receive either ASIST or TAU. 2. Complete psychological, clinical, and behavioral assessments before and after treatment. 3. Undergo measurements of cortisol and beta-endorphin levels. 4. Complete tasks during brain imaging assessments to measure brain activity and functional connectivity.

Evaluation of National Highly Specialized Care for Children and Adolescents With Severe Self-Harm or Eating Disorders

National Highly Specialized Care (NHV) is provided in Sweden to children and adolescents with severe and treatment-resistant self-harm or eating disorders when previous treatment has not led to sufficient improvement. NHV offers intensive, individualized care delivered by multidisciplinary teams with specialized expertise. This observational study aims to evaluate NHV provided at two specialized psychiatric services in Region Stockholm: Child and Adolescent Psychiatry Stockholm (BUP Stockholm), for severe self-harm, and the Stockholm Centre for Eating Disorders (SCÄ), for children with severe eating disorders. The primary aim is to explore patients' and their parents' or legal guardians' experiences of NHV and their perceptions of its effects through qualitative interviews conducted at treatment completion and one year later. Secondary aims are to evaluate treatment feasibility, adherence, and changes in psychiatric symptoms, functioning, and skills during and after treatment. Data are collected through questionnaires completed by patients and their parents or legal guardians, clinical assessments, and medical records. Assessments are conducted 1) at baseline, which is defined as the first treatment week, 2) after six weeks of treatment, 3) at regular treatment completion (approximately 12-13 weeks), 4) if the treatment is extended by 4-6 weeks due to, for example, severe comorbidity, an additional assessment is conducted at the end of this treatment extension, 5) at six-month follow-up, and 6) at twelve-month follow-up after treatment completion. The study aims to improve understanding of the benefits and limitations of NHV and contribute to the further development of specialized psychiatric care for children and adolescents with complex treatment needs.

Evaluation of National Highly Specialized Care for Adults With Treatment-Resistant Self-Harm and Eating Disorders: Substudy 1

This study aims to evaluate National Highly Specialized Care (NHV) for adults with severe and treatment-resistant self-harm or eating disorders in Sweden. The study examines patients' and their significant others' experiences of care, the feasibility of the treatment programs, and changes in patients' symptoms and functioning during and after treatment. Participants receive specialized inpatient care or a combination of inpatient and intensive outpatient treatment, based on their individual clinical needs. Treatment typically lasts approximately 12 weeks but may vary depending on the patient's circumstances. Additional interventions may be provided to address co-occurring psychiatric conditions. Information is collected through self-report questionnaires, qualitative interviews, and clinical records. Patients and their significant others are invited to complete assessments during treatment and at follow-up, including up to five years after treatment. The findings are expected to contribute to improving specialized care for people with severe self-harm and eating disorders.

Acceptance and Commitment Therapy-Based Chatbot for Non-suicidal Self-Injury in Adolescents

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.

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.

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.

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.

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.

Clinical and Psychosocial Characteristics of Adolescent Patients With Non-Suicidal Self-Injury

The overall objective of this study is to explore the social and clinical psychological characteristics of adolescents with depression accompanied or not accompanied by non-suicidal self-harm. This is an observational study. A total of 90 cases were included, with 30 cases in each of the case study group, case control group and healthy control group.