Clinical Research Directory

A Novel Auditory Application for Distraction in Pediatric Patients

This mixed-methods study seeks to evaluate the feasibility of Mystic Pets software and hardware within the pediatric population. This study will take place at Lucile Packard Children's Hospital (Stanford University, Palo Alto, CA).

Neurostimulation Versus Therapy for Problems With Emotions

The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills training, with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC). The secondary aim is to identify key changes in the emotion regulation neural network following the combined intervention versus each of the components alone. The third aim is to explore personalized biomarkers for response to emotion regulation training. Participants will undergo brain imaging while engaging in an emotional regulation task. Participants will be randomly assigned to learn one of two emotion regulation skills. Participants will be reminded of recent stressors and will undergo different types of neurostimulation, targeted using fMRI (functional MRI) results. Participants who may practice their emotion regulation skills during neurostimulation in a one-time session. Following this training, participants will undergo another fMRI and an exit interview to assess for immediate neural and behavioral changes. Measures of emotion regulation will be assessed at a one week and a one month follow up visit.

Impact of Emotional Status on Prognosis of Patients With BCLC Stage B/C Hepatocellular Carcinoma Undergoing Hepatic Arterial Infusion Chemotherapy Combined With Targeted and Immunotherapy

This study is a multicenter, prospective, observational clinical trial designed to evaluate the impact of baseline emotional status on the clinical outcomes of patients with BCLC stage B/C hepatocellular carcinoma undergoing HAIC combined with targeted immunotherapy. A total of 90 patients are planned to be enrolled and divided into a depressive mood group and a non-depressive mood group based on a PHQ-9/GAD-7 score of ≥5 points. The primary study endpoint is progression-free survival (PFS), and the secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety profile. Dynamic assessments of patients' emotional status, quality of life (EORTC QLQ-C30), and peripheral blood levels of neuroendocrine-immune markers will be conducted at preset time points. The results indicate that emotional status may serve as an important modifiable factor influencing the efficacy of comprehensive therapy in patients with advanced liver cancer, providing an evidence-based basis for the formulation of psychosomatic integrated clinical intervention strategies in the future.

The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury

The purpose of this research study is to determine whether COMA-F is more efficacious at reducing emotional distress in caregivers of patients with severe acute brain injuries, compared to health education control.

Impact of a Single Art Therapy Session on Mood and Symptom Burden in Palliative Care

The goal of this observational study is to explore whether a single art therapy session can improve mood and reduce symptom burden in adult palliative care patients at a Canadian inpatient unit. The main questions it aims to answer are: * Does a single art therapy session reduce overall symptom burden, as measured by the Edmonton Symptom Assessment System (ESAS)? * Does a single art therapy session improve mood, as measured by the Positive and Negative Affect Schedule (PANAS)? Participants will: * Complete two short questionnaires (ESAS and PANAS) before and after the session * Participate in a 30-60 minute individual art therapy session

Auricular Acupuncture on Emotional Distress in Service Members and Veterans With PTSD

Emotional distress (ED) refers to a state of mental suffering that significantly impairs an individual's ability to cope, often leading to a decline in overall well-being. In military contexts, ED is a prevalent concern due to the unique and demanding challenges faced by military personnel both in combat zones and during peacetime. The primary objective of this study is to assess the efficacy of integrating ear acupuncture with mindfulness therapy in mitigating ED and alleviating post-traumatic stress disorder (PTSD) symptoms among military personnel. The study will examine the effects of auricular acupuncture (AA) and mindfulness therapy (MT) on ED in military personnel with PTSD. The NADA ear acupuncture protocol will be administered using acupuncture semi-permanent (ASP), sterile needles placed in the bilateral ears, which will remain in place until they naturally fall out. Mindfulness therapy will incorporate relaxation techniques, such as yoga and controlled breathing exercises, specifically designed to alleviate ED. A mixed-methods approach, integrating both quantitative and qualitative methods, will be employed concurrently to evaluate the interventions' effectiveness and to explore the participants' perceived benefits. Specific Aim 1: To evaluate the effectiveness and perceived benefits of the National Acupuncture Detoxification Association (NADA) ear acupuncture protocol as an adjunct therapy to brief mindfulness therapy for reducing emotional distress in service members and veterans with PTSD. Specific Aim 2: To examine the effectiveness of NADA as an adjunct therapy to brief mindfulness therapy in improving sleep disturbances, alcohol use, and pain in service members and veterans with PTSD.

Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children

Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported prevention interventions are needed to prevent the onset of mental and behavioral health issues among these children. Building on our preliminary findings, the proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing behavioral health and interpersonal problems among racial and ethnic minority children who live in low-resource high poverty communities.

Emotional Intelligence Intervention to Improve Mental Well-Being of Adolescents With Emotional Distress (BEAM)

The goal of this clinical trial is to assess the effectiveness of a multicomponent intervention in adolescents with emotional distress. The main question it aims to answer is: Does the intervention increase mental well-being, emotional resilience, and emocional intelligence in adolescents with emotional distress? Participants will: • Participate in a multi-component intervention for 9 weeks at school.

Promoting Positive Emotions in Adolescents Using Positive Events Training: An Indicated Approach

Research shows that high positive emotionality is an essential ingredient in building resilience in youngsters, especially those with a vulnerability to develop depressive symptomatology. It may empower them against actual depression and its various long-term adverse outcomes. One way to achieve positive emotions is via the recollection and anticipation of specific positive events. Therefore, to cultivate positive emotions in young people, a user-friendly group training program was developed, translated from basic research findings: Positive Event Training (PET). Through PET, adolescents learn to solidify positive memories and positive plans for the future. In this project, a comprehensive evaluation of PET's efficacy is conducted using a robust methodology with vulnerable youth.

Resiliency Intervention for Patients With ALS and Their Care-Partners

The purpose of this study is to pilot a resiliency and coping intervention for persons recently diagnosed with Amyotrophic Lateral Sclerosis (ALS) and their primary informal caregivers. The data investigators gather in this study will be used to further refine our intervention.

Mind-body Resilience Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest

The purpose of this study is to pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.

Building Resiliency in Dyads of Patients With an ANI Admitted to the Neuro-ICU and Their Informal Caregivers

The purpose of the present investigation is to test the efficacy of a brief (6 sessions) dyadic (patient and caregiver together) intervention to prevent chronic emotional distress in at risk dyads admitted to a Neuroscience Intensive Care Unit with an acute brain injury. Through this study, we seek to solve the unmet need of preventing chronic emotional distress in Neuroscience Intensive Care Unit (NICU) dyads through a feasible, acceptable and credible program, and ideally improve the recovery trajectory and dyads' overall quality of life.

Therapeutic Writing for Adults Suffering From Chronic Pain and Comorbid Mental Health Disorders

The goal of this observational study is to understand the effects and experiences of therapeutic writing interventions in adult women with chronic pain and co-occurring mental health conditions. The main questions it aims to answer are: Can therapeutic writing help relieve chronic pain and emotional distress? How does writing support emotional processing, regulation, and meaning-making during rehabilitation? Participants will take part in a two-part writing intervention involving: Guided writing exercises that focus on emotional processing, emotion regulation, and creating meaning. Individual interviews after the writing sessions to explore their experiences. The study uses qualitative analysis methods-phenomenology and logotherapy-to better understand how these writing interventions may support recovery, improve well-being, and offer non-pharmacological tools for managing chronic pain and mental health challenges.

Temporal Dynamics of Mindfulness Intervention for Emotional Distress: Daily Interventions and Assessments

This research aims to adopt a complex systems perspective to thoroughly examine the impact of online mindfulness interventions on changes in emotional distress, with a particular focus on the mechanisms of action. Through a daily diary study design, the study seeks to reveal the complexity and dynamic characteristics of emotional changes and the underlying mechanisms（i.e. distress tolerance， experiential avoidance， cognition flexibility, and life engagement） throughout the intervention process. This research will enrich the theoretical framework of online mental health intervention and provide empirical evidence for optimizing online intervention strategies.

Mindfulness Interventions and Emotional Distress: A Daily Study

This study hopes to explore whether the changes in rumination exhibited in Daily Diary mediates the effects of mindfulness intervention on alleviating emotional distress

Mechanisms of Mindfulness Intervention：Rumination Behavioral Experiments

This study hopes to explore whether the changes in rumination exhibited in behavioral experiments mediates the effects of mindfulness intervention on alleviating emotional distress

Mechanisms of Mindfulness Intervention: Cognitive Flexibility Dose Manipulation

This study hopes to: 1. explore whether an increase in the dosage of cognitive flexibility intervention corresponds to greater effectiveness of mindfulness intervention in alleviating emotional distress. 2. explore whether cognitive flexibility mediates the effects of mindfulness intervention on alleviating emotional distress.

ReActivate: Physiotherapist Led Intervention for Adolescents With Pain and Psychological Distress.

Recurrent or persistent pain and psychological distress are alarmingly common problems among adolescents, in Sweden as well as globally. They often co-occur and have been shown to be predictors of sustained problems in adulthood. Adequate treatment early on in the development of problems has been shown important in order to decrease the risk of sustained problems in adulthood but available treatments have only modest effects. There is thus a need for treatment development, not in the least for (secondary) preventative purposes. The aim of this project is therefore to develop an evidence based and cost-effective secondary preventative intervention. Specifically, this project aims to develop and test a physiotherapist led treatment for adolescents with recurrent or persistent pain and psychological distress based upon graded exposure to physical activity and reactivation.

The OPERa Study: Evaluating QoL After Rectal Cancer Surgery

Advances in rectal cancer management have significantly reduced morbidity and mortality. The most commonly performed operation for rectal cancer is restorative proctectomy (RP), leaving up to 70% with long-term bowel dysfunction called Low Anterior Resection Syndrome (LARS). LARS manifests as stool frequency, incontinence and difficult defecation. LARS, along with other functional impairments such as sexual and urinary dysfunction (SUD), can impact quality of life (QoL) and cause emotional distress. High-quality longitudinal data on these sequalae are lacking, leading to variable estimates of their prevalence, risk factors and prognosis. Most studies are European, cross-sectional, lack pre-treatment evaluation and long-term follow-up, and use inconsistent assessment measures. Thus, a North American study that evaluates patients longitudinally from diagnosis will provide quality data to fill this knowledge gap. The main aim of the proposed study is to contribute evidence regarding the impact of LARS, SUD, emotional/financial distress, and patient activation on long-term post-treatment QoL in North American rectal cancer after RP. This multicenter North American, observational, prospective cohort study relies on validated patient reported outcome measures (PROMs) at diagnosis, during and post-treatment. Patients from 20 sites will be recruited over 2 years and followed for 3 years. The primary endpoint is QoL as measured by the European Organization for Research \& Treatment of Cancer QoL questionnaire. We anticipate accrual of 1200 patients. Factors associated with QoL will be explored. Impact of patient activation in relation to functional outcomes on QoL over time will be explored using a difference-in-differences approach. The study involves a multidisciplinary team who will provide expertise in research methodology, nursing, oncology and surgery. The main contributions of this study are 1) provision of reference baseline North American values for important rectal cancer PROMs for clinical and research use, 2) an understanding of the evolution of functional outcomes and QoL post-treatment to counsel patients peri-operatively and throughout survivorship, and 3) to provide the basis for future tailored programs to support rectal cancer survivors.