Clinical trials

This randomized controlled trial evaluates the effectiveness of ultrasound-guided retrolaminar nerve block in addition to standard multimodal analgesia for postoperative pain management in patients undergoing lumbar spine surgery. Fifty patients will be randomly assigned to receive either the retrolaminar block combined with standard pain management or standard pain management alone. The primary outcome is total opioid consumption in the first 24 hours after surgery. Secondary outcomes include pain intensity at multiple time points, time to first rescue analgesia, duration of sensory block, incidence of postoperative nausea and vomiting, length of hospital stay, patient satisfaction, and chronic pain development at 3 and 6 months follow-up.

Background. Suicidal ideation and depressive symptoms are highly prevalent among adolescents, with suicide representing a leading cause of death in this age group worldwide. School-based indicated prevention programs using cognitive behavioral therapy (CBT) have shown promise in addressing these mental health challenges. The Reframe-IT+ (Chile) and CARIBOU (Canada) programs are CBT-based, individually delivered interventions targeting adolescents at risk of suicide. This study aims to evaluate a culturally adapted stratified-care model using these two interventions, matched to depressive symptom severity. Methods. This is a quasi-experimental, single-arm study with pre-post assessments and follow-ups at 3, 6, 9, and 12 months. Six secondary schools with high socioeconomic vulnerability in Santiago, Chile, will participate. Students with suicidal ideation and mild/moderate depressive symptoms (PHQ-9 \< 20) will be offered Reframe-IT+, while those with severe symptoms (PHQ-9 ≥ 20) will be offered CARIBOU. Primary outcomes include the acceptability of CARIBOU, feasibility of the stratified-care model, and implementation fidelity. Secondary outcomes include reductions in suicidal ideation, depression, anxiety, hopelessness, and improvements in functioning, quality of life, behavioral activation, emotional regulation, and problem-solving skills. Discussion. This protocol addresses the need for scalable, culturally sensitive interventions for adolescent suicide prevention in school settings. By evaluating both the process and early outcomes of a stratified-care approach, this study will generate valuable evidence to inform future large-scale effectiveness trials and policy development in adolescent mental health.

Mental health in university students is a growing concern worldwide. In Chile, previous studies have shown high rates of depressive symptoms, anxiety, and suicidal risk in this population. This study seeks to evaluate the acceptability and feasibility of a Cognitive Behavioral Therapy (CBT)-based intervention for the indicated prevention of suicidality in undergraduate students, and also to explore its impact on reducing suicidal ideation. A quasi-experimental before-and-after design will be used with a sample of students from the Universidad de los Andes who present mild to moderate suicidal risk. As this is a pilot study, a sample size calculation is not required, but we expect to recruit 20 subjects, which will allow us to conduct acceptability and feasibility assessments and collect data for a larger-scale study. A follow-up will consist of repeating the initial assessment questionnaire, which will be completed two and four months after the intervention. The methodology includes an initial interview to assess inclusion and exclusion criteria, signing informed consent, and developing a safety plan with the students. Following this, six weekly sessions (three in-person and three with digital components) of 60 minutes each will be held, focusing on emotional regulation, cognitive restructuring, and problem-solving. The intervention will be facilitated by trained psychologists, under the supervision of a trained psychologist or psychiatrist. To assess acceptability, the Client Satisfaction Questionnaire (CSQ-8) will be primarily used. To assess outcomes, validated instruments will be applied, such as the Columbia Suicide Risk Scale (C-SSRS), the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms, the Generalized Anxiety Disorder 7 (GAD-7) for anxiety symptoms, the Short Form-12 Health Survey (SF-12) for quality of life, the Distress Tolerance Scale (DTS) for stress tolerance, the Community Assessment of Psychic Experiences-Positive (CAPE-P15) for psychotic symptoms, the Difficulties in Emotion Regulation Scale (DERS-E) for emotional regulation, the Social Problem-Solving Inventory-Revised (SPSI-R) for problem-solving, and the Cognitive-behavioural Therapy Skills Questionnaire (CBTSQ) for cognitive-behavioral skills. Reduction in suicidal ideation, satisfaction with the intervention, and program adherence will be measured. The study hopes that the prevention program, along with the proposed assessments and procedures, will be appropriate and feasible in a university setting. This will allow progress toward a larger randomized controlled trial. Furthermore, it is expected that students in the intervention group will experience a reduction in suicidal ideation.

Mental health among university students has emerged as a significant global issue. Recent meta-analyses reveal that 25% of students experience depressive symptoms and 14% exhibit suicidal behaviors. A study involving 19 universities across 8 countries found that 31.4% reported psychiatric disorders in the past year, particularly major depressive episodes and anxiety disorders. In Chile, research on university mental health is limited. A 2014 study at Universidad Austral reported a 27% prevalence of depression and a 5.3% risk of moderate to severe suicide risk. The "First National Survey of University Mental Health" in 2019 revealed that 46% of students had depressive symptoms, while health surveys from Universidad de los Andes in 2020 and 2022 showed a decrease in these symptoms, although suicide risk remained high. Given this situation, preventive interventions are urgently needed. "Mindfulness-Based Interventions" (MBIs) have shown effectiveness in university settings. Mindfulness, defined by Jon Kabat-Zinn, involves deliberate, non-judgmental attention to the present moment. Programs like "Mindfulness-Based Stress Reduction" (MBSR) have proven effective in reducing symptoms of depression, anxiety, and stress. Studies indicate that MBIs can effectively alleviate mental health symptoms in university populations. Some of the MBIs include "Mindful Mood Balance" (MMB) and "Mindfulness Skills for Students". The latter has shown effectiveness in reducing depressive and anxious symptoms among university students. A 2021 pilot study at Universidad de los Andes on an online 8-session intervention combining mindfulness with cognitive-behavioral techniques yielded positive results in reducing symptoms and enhancing students' quality of life. In the current proposal we want to evaluate the feasibility and acceptability of the "Mindfulness Skills for Students" program delivered in-person by two trained facilitators. Additionally, we want to explore the efficacy of this intervention in reducing depressive, anxious, and stress symptoms among undergraduate students at Universidad de los Andes, using a quasi-experimental study design.

The goal of this clinical trial is to evaluate the efficacy of using L-PRF (leukocyte and platelet rich fibrin clot) as an autologous filling material in conjunction with the EPP (entire papilla preservation) technique for the treatment of interproximal intraosseous periodontal defects, compared to the same technique without L-PRF regarding clinical periodontal parameters and obtained radiographic parameters. It will also report possible postoperative complications and evaluate postoperative sensitivity. The main questions it aims to answer is: • What is the effectiveness of LPR-F in conjunction with a complete papilla preservation (EPP) technique for the treatment of intrabony periodontal defects in CESA (health care center) patients in terms of clinical and radiographic periodontal parameters compared to the use of the same technique without L-PRF? A non-randomized controlled clinical trial will be conducted on patients at CESA of the Universidad de los Andes. In 30 patients, 30 periodontal defects associated with a pocket with probing depths equal to or greater than 6 mm will be treated using the complete papilla preservation technique, either with L-PRF filling or without any filling material, assigned randomly to each intervention (15 participants in each group). Researchers will evaluate clinical and radiographic parameters at baseline and 6 months post-surgery. Patients will report their level of pain 24 hours and 7 days after surgery.

The objective of this clinical trial is to know if supplementation with extra virgin olive oil (EVOO) during pregnancy, improves the maternal and neonatal lipoprotein profile, lipoprotein function, oxidative status and vascular dysfunction markers in pregnancies with maternal supraphysiological hypercholesterolemia (MSPH). The main questions to be answered are: 1. Does 12 weeks of EVOO supplementation improve lipid and vascular outcomes in MSPH women at the end of pregnancy? 2. Does 12 weeks of EVOO supplementation improve lipid and vascular outcomes in MSPH neonates at the end of pregnancy? The investigators will compare regular diet supplemented with EVOO vs. intake of a non-supplemented regular diet to determine if EVOO reduces impaired vascular and lipid outcomes in the mother and her newborn. Participants: The recruited pregnant women will eat their normal diet (control group) or the same diet supplemented with 36 mL of EVOO daily (EVOO group). The protocol will be carried out from gestational week 28 to the end of pregnancy. A nutritional specialist will evaluate every 4 weeks the EVOO consumption through surveys developed through a zoom interview. The recruited pregnant women will have the regular obstetric control every 4 weeks. At delivery, a maternal sample of blood as well as umbilical cord blood and the placenta will be obtained for experimental analysis.

The 10-minutes project is an experimental study to assess the impact of a SEL program for children in 3th and 4th grade and their teachers called 10-minutes. The program is a curriculum that provides 10-minute activities (thus the name) for children to be implemented by the teachers daily throughout the school year. The activities do not require prior knowledge of teachers on SEL development, nor planning or material preparation. The 10-minute project is a quantitative study developed to evaluate whether the 10-minute curriculum and an expanded version with professional development activities for teachers or counselors, 10-minute plus, at third grade would improve students and teachers' socioemotional competence. The randomized control trail involves 30 schools in Chile, matched on socioeconomic measures, size, and urban/rural conditions, assigned randomly to 1 of 3 conditions. Ten schools will receive 10-minutes only, the SEL curriculum taught by teachers or school counselors, during the 2024 and 2025 school years. Ten schools will receive 10-minutes plus during the 2024 school year. Ten schools will serve as "delayed program" control, which will have the opportunity to receive the program (10-minutes plus) after the final follow-up. To examine the possibility of fade-out of the effects of the SEL intervention on students, the first experimental condition (10-minutes only) will be randomly divided into two groups, one will receive the intervention for one year only, whereas the second one will receive the intervention for two consecutive years. It is expected the program will yield positive effects on the experimental groups (both students and teachers), and effects are expected to be greater in the group offered the 10-minutes plus intervention which entails both a curriculum for children and professional development for teachers, than the effects in the group offered the 10-minutes curriculum exclusively. If the program proves to be effective, then cost-benefit analyses will follow to assess the efficiency of the program. The estimated benefits of the program are expected to be lower than the costs.

Mental health disorders are one of the leading causes of illness globally, and their relevance is expected to increase. Low and Middle Income Countries (LMIC), already facing psychological and behavioral issues due to chronic adversity, were further impacted during the COVID-19 pandemic. A study showed that symptoms of depression and anxiety in youth doubled during the first year of the pandemic compared to the pre-pandemic period. A study in China found that the prevalence of the total difficulties was (8.2%), with conduct problems (7.0%), peer problems (6.6%), and hyperactivity-inattention (6.3%) among the most prevalent. In this study emotional problems reached 4.7%. Finally, recent evidence has revealed that students' psychosocial and behavioral problems have increased in the early stage of schools reopened. Several international agencies have calls on governments, and public and private sector partners, to commit, communicate and act to promote mental health for all children, protect those in need of help, and care for the most vulnerable. The importance of psychosocial skills acquired in early childhood, such as emotional regulation and social problem-solving, for preventing mental disorders was highlighted. Studies indicate that the development of executive functions and non-cognitive skills in early childhood has a positive impact on long-term health and economic productivity. However, the treatment gap for mental disorders in LMIC is significant, with only one in ten affected receiving treatment. Preventive interventions are needed, particularly in early childhood, to improve cognitive and socio-emotional skills. Objective: The research proposal aims to develop a gaming platform aiming to improve cognitive and non-cognitive skills in early childhood at schools with high socio-economic vulnerability, supported by Early Years Educators and Parents using a dashboard integrated in a whole system housed in local server, and to evaluate the acceptability and feasibility of this gaming platform and dashboards, with the ultimate goal of reducing behavioral problems, and improving functional and performance outcomes later in life. Outcomes: Acceptability; Feasibility; Cognitive and non-cognitive skills; Working Memory; Inhibitory control; Emotion recognition; Social competence; Behavioral problems and psychological assessment.