Clinical Research Directory

tAN for First Responders

This study is designed as an open label, single arm, decentralized clinical study in which first responders will receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) via the mastoid and the auriculotemporal nerve (ATN) anterior to the tragus. Participants will be enrolled in the study over the course of eight weeks (56 days). Participants will respond to daily and weekly questionnaires regarding mood, stress, sleep, energy/fatigue, and burnout. Each week, participants will complete consolidated online questionnaires (intended to last no longer than 15 minutes) comprised of the Perceived Stress Short-Form (PSS-4), Well-Being Index (WHO-5), Mini-Z Burnout (5-item), PROMS Sleep Disturbance (PROMIS-SD), GAD-7 (every 2 weeks), and Perceived Stress (PSS-10; monthly). The PSS-10 will replace the PSS-4 on Days 0, 28, and 56. No tAN treatment will be delivered during the Baseline Period (days between Study Introduction and Day 0). Participants will complete the weekly set of questionnaires ("Weekly Questionnaires") on Day 0. Participants will be recommended to complete the daily set of questionnaires ("Daily Questionnaires ") on the other days of the Baseline Period. On Days 1 - 28, participants will self-administer one session of one to two hours of tAN therapy each day. Participants will be recommended to complete the daily tAN session post-shift prior to sleep. Weekly Questionnaires will be completed by participants on Study Days 0, 7, 14, 21, 28, 35, 42, 49, and 56. Participants will be recommended to complete Daily Questionnaires on all other study days, up to Day 28. Daily Questionnaires will not be required to be completed by participants. Daily tAN sessions and Daily Questionnaires will cease after Day 28. Participants will complete a Study Satisfaction Questionnaire with the Weekly Questionnaires on Day 56. Following Day 56, participants will schedule a Study Exit Interview with the Research Coordinator.

Cranberry Polyphenols and Stress Resilience During Multitasking in Healthy Adults

This randomized, double-blind, placebo-controlled clinical trial evaluates whether 70 days of daily cranberry juice consumption improves cognitive performance and motor accuracy and reduces psychological and physiological stress responses during a motor-cognitive dual-task multitasking challenge in healthy adults aged 30-55 (Aim 1). It is hypothesized that chronic cranberry juice intake will enhance dual-task performance and attenuate stress reactivity (Hypothesis 1). It is further hypothesized that cranberry juice will mitigate multitasking-related fatigue, mood fluctuations, and cognitive impairment, accompanied by favorable changes in circulating stress biomarkers and stress-regulatory neurochemical pathways (Aim 2/Hypothesis 2). Finally, the study incorporates gut analysis to determine whether cranberry juice induces beneficial shifts in the gut microbiota and microbial metabolites (e.g., SCFAs) and whether these changes are associated with improved cognitive and stress-related outcomes, consistent with a microbiome-gut-brain axis mechanism (Aim 3/Hypothesis 3).

Influence of Melatonin on Cardiovascular and Thermoregulatory Responses to Stress

This study aims to evaluate the influence of acute oral melatonin supplementation on cardiovascular and skin temperature responses to mental stress. The hypothesis is that acute melatonin will lead to reduced cardiovascular and skin temperature responsiveness to acute mental stress.

The Effectiveness of Mental Wellness Youth Hubs in Hong Kong

This study sets out to evaluate (i) whether the model in phase two can improve symptoms, quality of life, functioning, and psychological outcomes in young people utilising the hub services (n = 600) compared to those in the community controls (n = 600), (ii) the mechanisms that may drive these improvements, and (iii) whether any particular subgroup(s) of youths (e.g., gender, socio-economic status, migrant status) may benefit more from this service model. The experiment group will include 600 hub users who are not currently using psychiatric medications and do not have a formal diagnosis at the time of enrolling in the hub activity. The control group will also comprise of 600 young people, recruited from a community cohort managed by the research team. The community cohort is accessible via the Youth Epidemiological Study Online platform (YES online), which recruits young people aged 12 to 24 years. Only YES online participants who are not using the service of LevelMind@JC and psychiatric medications will be recruited for this study. The two groups will be matched in age, gender, and baseline distress level measured by the 6-item Kessler Psychological Distress Scale (K6). There will also be a substudy assessing the effect of four service models: NLPRA eClinic, Integrated Community Centre for Mental Wellness (ICCMW) step-up care, general practitioners, and hub casework support service on symptom-based mental health outcome, comparing a cohort of young people receiving these four services respectively. A total of 252 participants will be recrruited. Another substudy will be conducted to investigate the extent to which participation in Tier 1 activities contributes to improvements in targeted outcome areas, assessing young people (n = 675) before and after their participation of Tier 1 activities. A consecutive sampling will be used, where a subject who meets the criteria of inclusion will be selected until this required sample size is achieved.

A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress.

The goal of this clinical trial is to compare the effect and time consumption of the Swedish translation of the protocol for RNT-ACT with the internet administrated self-help treatment with therapist support (iCBT) for patients seeking medical care for depression, anxiety or stress at their primary care unit. The trial consists of a feasibility study and a randomized controlled trial with 3- and 12-month follow ups.

Co-occurence of Mental Illness and Problematic Alcohol Use: an Internet-based Cognitive Behavior Therapy Intervention

The goal of this clinical trial is to learn if internet-based cognitive behavior therapy (ICBT ) works to treat co-occurent of problematic alcohol use and mental illness including mild to moderate symptoms of either depression, anxiety, stress or disturbed sleep. The main questions the study aims to answer are: * Does the ICBT program lower the self-rated suffering from mental illness? * Does the ICBT program lower the self-reported alcohol intake? Researchers will compare the ICBT program to the participants who are rancomized to a control grout that receives weekly attention from the research team, to see if the treatment works. In both groups, the participants will have the opportunity to ask for support from a therapist during the week days. Participants are adults living in Sweden. They will: * Receive an ICBT program supported by a trained therapist. It consists of modules that the participants will work with on their computer for 10 weeks. Some modules will be compulsory and other optional for the participants. * Fill out forms to rate their mental illness and alcohol intake at the start and the end of the study as well as once every week during treatment. Primary outcome measures are depression, anxiety and stress symptoms (measured with Depression Anxiety and Stress Scale 21 (DASS-21)) and alcohol intake measured with self-reported amounts. Other, secondary, outcome measures used will for example be about insomnia symptoms and disability assessment. Pre-treatment measurement, post-treatment measurement and 6-months and 12-months follow up is planned to be collected through an online survey.

Mental Health of the Polycrisis Generation

The goal of this observational, longitudinal study is to identify risk and protective factors that buffer the effects of individual daily stress and adaptation to global crises on the quality of life and mental health conditions of young people entering adulthood (aged 18-29, fluent in Polish, and living in Poland). Moderators such as factors related to development, personality variables compatible with the domains according to ICD-11, psychological resilience, closeness in relationships with a partner/friends/parents, and the level of postformal thinking will also be considered. The main hypotheses it aims to consider are: H1: Poorer adaptation to individual and global crises is associated with higher levels of perceived stress, leading to worse indicators of mental health and quality of life. H2: A higher level of implementation of developmental tasks, including more fulfilled criteria of adulthood and a mature identity, mitigates the relationship between stress/ crisis adaptation and health and quality of life indicators. H3: Resilience and better relationships (closeness with a partner/ friends/ parents) buffer the negative effect of stress on health and quality of life. H4: A higher level of postformal thinking mitigates the relationship between stress/ crisis adaptation and health and quality of life indicators. H5: A higher intensity of psychopathological personality traits is a risk factor that amplifies the negative effect of stress on health and quality of life. Researchers will analyze measurements taken from the same group (a representative sample of Polish young adults) at two time points - now and in 12 months. The aim is to observe the extent to which the effects of current daily stressors and adaptation to the crisis, as well as the effects of potential moderators, are relatively stable.

Effects of a Virtual Reality Intervention on Mental Health Outcomes and Academic Success in Physical Therapy Students

Exploring the impact of a virtual reality program, First Resort on graduate physical therapy student wellness and academic success.

Emergency Medical Staff Workload Analysis

The aim of this study is to identify trauma determinants and leverage this understanding to develop solutions applicable to the prevention and treatment of PTSD among emergency medical personnel. By categorizing stimuli associated with traumatic professional experiences, the study aims to enhance existing therapeutic protocols through exposure therapy. The specific objectives are as follows: 1. Analysis and characterization of occupational workloads among doctors and emergency medical personnel, focusing on the scale of burdens associated with PTSD symptoms. 2. Development of categories for aggravating and potentially traumatizing stimuli within the medical staff of rescue teams. 3. Examination of the feasibility of incorporating the obtained results into cognitive-behavioral therapy protocols. 4. Assessment of the potential for implementing the results in solutions utilizing virtual reality technology. 5. Formation of an interdisciplinary international research team.

Heart-brain-axis and Psychosocial Stress

The main study objective is to prospectively determine the influence of sex-related risk factors and psychosocial variables on neuronal stress responses and myocardial perfusion in a population of 64 female and male individuals 50-75 years of age and free of cardiovascular disease.

Virtual Agents-based Digital Interventions to Improve Health

KANOPEE is a free smartphone application providing screening, follow-up tools and autonomous digital interventions to lower psycho-social stress and its repercussions on sleep and behaviors in the general population. Additionally, KANOPEE permits an adaptation of the intervention to the subject (i.e., an adapted waiting period, frequency, and content), enabling to perform innovative trial conditions. The objective of this long-term study is to evaluate the efficacy of KANOPEE on users among the French general population exposed to psycho-social stress.