Emotional Dysregulation

The primary purpose of this study is to evaluate the efficacy of centanafadine once daily (QD) extended-release (XR) capsules in adults with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED).

This study aims to evaluate the feasibility and preliminary effects of the MIND-SET Intervention Module, an integrated Motivational Interviewing and Rational Emotive Behavior Therapy (MI-REBT) intervention, among Malaysian primary school students involved in Non-Suicidal Self-Injury (NSSI) behaviour. The module is designed to reduce self-injurious behaviour, improve emotional regulation, and enhance readiness for change among 12-year-old students in school settings. This study will use a quasi-experimental design involving three groups: a MIND-SET intervention group, a PRISMA Mental Health Module group, and a treatment-as-usual group. Data will be collected at pre-intervention, post-intervention, and follow-up stages using validated psychological instruments. The findings are expected to support the development of culturally responsive, school-based mental health interventions for children involved in NSSI behaviour in Malaysia.

This prospective observational study follows adults undergoing residential rehabilitation for severe substance use disorders at a specialized treatment center in Mexico. Participants provide weekly written narratives describing their emotions, challenges, coping strategies, and treatment experiences, and complete validated psychological questionnaires every two weeks, including the Generalized Anxiety Disorder-7 (GAD-7), Environmental Reward Observation Scale (EROS), Automatic Thoughts Questionnaire-8 (ATQ-8), and Behavioral Activation for Depression Scale (BADS). The study applies natural language processing (NLP) and machine learning methods to analyze participants' narratives and identify emotional, cognitive, and behavioral patterns associated with clinical change over time. Narrative-derived features are combined with questionnaire scores to generate a dynamic clinical risk representation that may help detect early signs of psychological worsening or improvement during residential treatment. Participants continue receiving standard residential care, and the study does not modify treatment decisions or clinical interventions. Up to 35 participants with sufficient longitudinal follow-up data will be included in the primary analysis. Data collection is expected to continue through September 2026.

This cross-sectional study examines associations among heart rate variability (HRV), emotional dysregulation, and parent-adolescent relationship quality in adolescents with Major Depressive Disorder (MDD). We hypothesize that lower HRV will be linked to greater emotional dysregulation and that more supportive parent-adolescent relationships will correlate with higher HRV. Participants will wear a Fitbit Charge 5 during nighttime sleep for 7 consecutive nights and complete validated measures of emotional regulation and relationship quality.

The aim of this clinical trial is to evaluate whether AGENCIA, a brief psychological program supported by digital technology and artificial intelligence, can help reduce emotional and behavioral difficulties in adolescents aged 12 to 18. These difficulties may include irritability, impulsive behaviors, conflicts at home or at school, or difficulties in managing intense emotions. The study also aims to determine whether the effects are similar across adolescents with different symptom profiles or neurodevelopmental characteristics. Participants will be randomly assigned to one of three groups: AGENCIA Digital: a self-guided online version completed at home. AGENCIA in-person with a digital assistant: a clinician-delivered version supported by an interactive digital assistant to guide the exercises. Digital psychoeducation (control): a self-guided online program providing general information about adolescent well-being. The main research questions are: Does AGENCIA reduce overall emotional and behavioral difficulties? Does the program improve functioning, family accommodation, and personal agency (a young person's sense of being able to act and make changes)? Are the effects similar across adolescents with different profiles or neurodevelopmental characteristics? Participants will: * Complete three structured sessions depending on their assigned group. * Complete brief online questionnaires at baseline (T0), immediately after the sessions (T1), and at 1-month (T2) and 6-month (T3) follow-ups. * Receive brief phone calls during follow-ups to support questionnaire completion. A total of 465 adolescents will take part in the study. Participation is voluntary and does not replace usual clinical care. The study does not involve medication or invasive procedures, and all digital tools operate within secure institutional systems.

This is a double-blind randomized controlled study. The study will last up to 16 weeks from the initial phone screen (it could take up to eight weeks to schedule and complete the initial screening process and schedule the 2 MRI visits). Once subjects have completed the screening process, they will begin the 8-week trial phase. Subjects will be assessed weekly throughout the study for efficacy and tolerability. The investigators plan to recruit 80 participants with emotional dysregulation (ED) in the treatment arm. In addition, the investigators will aim to recruit 40age-, sex-, and parental-education matched participants without emotional dysregulation, and major psychopathology as Typically Developing (TD) control participants in the control arm. Upon scheduling the baseline visit, only the emotional dysregulation (ED) participants will be randomized 1:1 to be exposed to NAC or placebo treatment for 8 weeks. Participants will complete baseline and post-treatment (endpoint) brain MRI acquisition. TD participants will complete the same screening and characterization process as the ED group and then will be invited to complete MRI eligibility screening and to be scanned twice, separated by an eight-week interval, but the TD will not complete the NAC treatment or receive a placebo. See Table 1 (Study Schema) for a complete list of characterization measures to be completed by each group.

Emotional dysregulation in justice-involved youth (JIY) is a condition that significantly impacts young people, their families, and juvenile justice and public health systems. Affecting an estimated 60-70% of detained Attention deficit hyperactivity disorderadolescents, it is a major driver of aggression, substance use, school failure, and later recidivism. Despite available treatments, managing emotional dysregulation in custody remains challenging, with youth often enduring high arousal, anger, and anxiety that persist into adulthood. Current popular therapies, including Cognitive Behavioral Therapy (CBT) and Dialectic Behavioral Therapy (DBT), often fall short in detention because they rely on verbal processing, require multiple scheduled sessions, and/or need highly trained staff. Other technologies, like biofeedback and neurostimulation techniques, are still under scrutiny for adolescents, given their higher-than-usual Adverse Events (AEs). This SoundHeal study aims to evaluate a sensory intervention using the Healpod, a distraction-free physical space where a participant sits, delivering sound, music, gentle vibrations, and ambient light. Following this is a brief expressive journaling exercise to compare any before, during and after experience changes from the sensory immersion. This prospective, single-center cohort study hypothesizes that these sessions will improve juveniles' ability to emotionally regulate, improve therapeutic alliance, mental health outcomes and build coping skills that can potentially help in long-term mental health and substance abuse treatment in JIY and beyond.

In psychiatry, psychotherapy is, along with pharmacotherapy, a major therapeutic intervention. It helps patients better understand their difficulties and informs them of possible solutions. It is systematically recommended in cases of psychiatric disorders, whether or not in combination with pharmacotherapy. With regard to addictive disorders in particular, few medications are available and psychotherapy is essential. Psychotherapy must be adapted to the severity of the patient's condition and the issues encountered. In cases of impaired emotional regulation, i.e., the ability to respond effectively to one's emotions, addictions become more difficult to stabilize without appropriate treatment. For patients with emotional regulation disorders, Dialectical Behavior Therapy (DBT) is the standard treatment. It consists of teaching acceptance and change skills in a dialectical manner to better regulate emotions. Like other evidence-based psychotherapies, DBT is nevertheless not widely available. It requires therapists to have a high level of training and sufficient patient recruitment to form groups. Two solutions are being considered to improve the accessibility of DBT. To facilitate patient recruitment, transdiagnostic groups are useful because they bring together patients with different diagnoses. To help professionals deliver the therapy, digital tools such as pre-recorded videos or mobile applications have proven effective, particularly when guided by a therapist, but they also show some effectiveness without a therapist. Studies are still recent and few in number, and need to be replicated, particularly using a variety of digital tools. The investigators want to evaluate the effectiveness of DBT on emotional regulation and impulsivity in addiction patients, in a transdiagnostic face-to-face format and in an online format using videos, compared to a control group (usual treatment). This research would provide a better understanding of the effectiveness of DBT in addiction treatment, as well as the effectiveness of solutions that improve its accessibility, such as the transdiagnostic format and the use of associated digital tools.

The goal of this observational study is to learn if and how pharmacological and psychotherapeutic group treatments can treat clinical symptoms of children and adolescent patients with ADHD. The main questions it aims to answer are: * Are pharmacological and psychotherapeutic treatments effective on the clinical symptoms of patients with ADHD? * Are pharmacological and psychotherapeutic treatments effective on symptoms of emotion-behavioral dysregulation? * Is it possible to find associations between individual characteristics and treatment responses evaluating behavioral and neural correlates in children and adolescents with traits of emotion-behavioral dysregulation, externalizing disorders, and/or ADHD, using a panel of multimodal measures. May the data collected contribute to the definition of profiles useful for generating predictive hypotheses aimed at developing more personalized interventions? Researchers will compare the data collected from patients treated with pharmacological and psychotherapeutic group treatments with the data of subjects of comparable sex/gender, age, diagnoses, on the waiting list for treatment to see if pharmacological and psychotherapeutic treatments effects ADHD and emotional dysregulation symprtoms. Participants, patients who are offered treatment by clinicians according to standard clinical practice, will be asked to participate in the study by undergoing experimental assessments before and after the treatment. The multimodal panel of proposed assessments includes: * behavioral assessments, conducted through the completion of clinical and socio-demographic questionnaires; * neuropsychological assessments, conducted through standardized computerized neuropsychological tests; * neurophysiological assessments, conducted through the recording of NIRS (near infrared spectroscopy) and EEG (electroencephalogram) signals during an attentional task (Go-NoGo) and via a smartwatch.

The study aims to assess the efficacy of culturally adapted dialectical behaviour therapy (DBT) for addressing emotional dysregulation in a low- and middle-income country, as well as to evaluate the impact of DBT on secondary outcomes such as borderline personality traits, self-harm or suicide, depression, anxiety, and individuals' functioning and disability. Through a rigorous Randomised Controlled Trial (RCT), the research seeks to assess how cultural adaptations of dialectical behaviour therapy improve its applicability, engagement, and outcomes in diverse socio-cultural settings, contributing to more accessible and effective mental health interventions in resource-limited regions.

This study aims to evaluate the effectiveness of Child-Parent Psychotherapy (CPP) in reducing trauma-related symptoms and improving attachment quality among preschool-aged children who experienced the 2023 Kahramanmaraş earthquakes in Türkiye. A total of 60 caregiver-child dyads (children aged 3-6) will be recruited from 11 earthquake-affected provinces. Participants will be randomly assigned to either the intervention group, receiving 12 weekly CPP sessions, or a no-intervention control group. CPP will be delivered by trained clinical psychologists through either online or face-to-face sessions. Assessments will be conducted at baseline, mid-intervention (after session 6), and post-intervention (after session 12). Outcomes include child trauma symptoms, social-emotional functioning, and attachment quality, as well as caregiver reflective functioning, stress, and emotional well-being.

Aims: 1. To co-produce new intervention parts that meet the needs of LGBTQ+ people at risk of self-harm or suicidal thoughts, with LGBTQ+ people and DBT therapists. These intervention parts will be integrated into a Dialectical Behaviour Therapy (DBT) intervention, that is provided earlier in a persons mental health care journey, than DBT is usually targeted at. 2. To assess how acceptable and feasible the co-production process was for participants, and how well it achieved co-production principles (e.g. participants feel supported, that the aims were transparent, etc). Why is This Important? Young people who identify as lesbian, gay, bisexual, transgender, queer, and with other minoritised gender and sexual identities (LGBTQ+) are much more likely to self-harm and experience suicidal thoughts than cisgender-heterosexual (non-LGBTQ+) people. They also experience barriers when accessing mental health support. Some of these barriers come from a lack of support tailored towards their needs as an LGBTQ+ person. This often means that things get worse before they access the right support, and so are often seen in higher-intensity interventions (tier 4 or tertiary care), like DBT. What The Investigators Plan to Do: The investigators plan to hold some focus groups with three different groups of people to co-produce the new intervention parts. The three groups include: 1. A group of LGBTQ+ young people (13-21 years old) who have completed a at full DBT programme recently. 2. A group of LGBTQ+ young people (13-21 years old) who have never been in a full DBT programme but experienced similar difficulties. 3. A group of DBT therapists who have supported LGBTQ+ young people before. The investigators will seek feedback from participants about how acceptable they found the study (e.g. how satisfied they were with the process), how feasible it was (e.g. were they able to attend and was it practice?), and how well they stuck to the coproduction principles (e.g. how supported they felt).

The goal of this clinical trial is to examine the effects of a music therapy program in adolescents aged 13-18 years old with emotional difficulties, primarily depression and possibly concurrent diagnoses of anxiety. The main questions are: * What recruitment methods, barriers, and facilitators influence study participation among adolescents with emotional difficulties receiving music therapy in the present study? * Does music therapy contribute to a significant reduction in depression and anxiety symptoms, inclusive concomitant symptoms? * How do adolescents with emotional disorders perceive participation in music therapy, and how do they articulate its potential impacts on their health and well-being? Participants will be invited to participate in a music therapy program, in addition to standard treatment given (TAU). They meet individually in the clinic with a professional music therapist once a week over a period of ten weeks. They will also do musical home exercises between the sessions. Psychiatric interviews and clinical assessments will be conducted before treatment. Assessments and questionnaires will be performed right after the therapy program and three months after ended therapy. There will also be conducted qualitative interviews with a subgroup of the participants.

To assess the effectiveness and security of a mobile App (beta version) for people with borderline traits recruited from a non-clinical population of college students in Barcelona (Spain). The main primary outcome will be the severity of the emotional dysregulation. Forty participants will use the mobile app over 6 months. This group while be compared at post-treatment and at 3-month follow-up with other 40 participants (control group) with any intervention.