Clinical Research Directory

Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years

Overweight and obesity, as well as periodontitis, are common public health problems with increasing prevalence. Both conditions may be linked through shared mechanisms involving chronic low-grade systemic inflammation. Numerous studies have reported an association between elevated body mass index (BMI) and periodontitis, particularly among younger and working-age populations. However, data regarding Thai adults under the age of 60 remain limited. Therefore, this study aims to determine the prevalence of high BMI and periodontitis among Thai adults aged 18-59 years and to identify factors associated with these conditions. The findings may provide useful information for improving awareness and supporting the prevention of both periodontal and general health problems in this population.

Virtual Reality Viewing of Unaltered Streetscape Versus Digitally Manipulated Opposite Streetscape to Assess Psychosocial Response in Participants

This clinical trial compares virtual reality viewing of an unaltered streetscape versus a digitally manipulated opposite streetscape to assess the psychosocial response in participants. Visible measures of neighborhood factors might be associated with health outcomes and risk factors of those outcomes. Short-term exposure to virtual reality environments representing very high or very low levels of neighborhood physical disorder - presence or absence of garbage/litter, presence or absence of graffiti, presence or absence of an abandoned building, presence or absence of large dumpsters, poor or very well-kept building conditions, poor or very well-kept yard conditions, poor or very well-kept road verge conditions may be a safe and effective way to assess psychosocial response in participants.

Medical Comorbidities in Bipolar Disorder

Bipolar Disorder (BD) is a common, heritable, chronic, and recurrent disorder that represents a critical public health problem, due to its prevalence, its high degree of disability and psychiatric and MC (MC): these represent a significant additive burden for BD patients, with a large clinical heterogeneity and an urgent need for personalised treatment and management. BIPCOM overarching purpose is to study MC in people with BD and to improve diagnostic and treatment outcomes with a precision medicine approach targeting 3 objectives: (1) to identify prevalence rates, risk and protective factors and natural history of MC among subjects with BD, through analyses of the Nordic biobanks and medical registers Work Package WP(WP2) and a cross- sectional study exploiting existing datasets of patients with BD (WP3); (2) to conduct an Exploratory Clinical Study (ECS - WP4) involving 400 subjects (80 X 5 recruiting sites), to assess the overall clinical profile of these patients and quantify the 1-year incidence of specific risk factors for the onset of metabolic syndrome (MetS) (WP5); (3) to develop a Clinical Support Tool (CST), including a set of recommendations, to support individualized clinical decision-making in BD comorbidity management and improve prevention, early detection and effective treatment, while ensuring the translation of project results' into clinical practice (WP5 and 6). BIPCOM will be implemented through continuous consultations with stakeholders (scientific and patients' associations, users and families), for ensuring results' acceptability and transferability. The successful implementation of the project will have a significant impact upon the general health of people with BD, eventually leading to lower mortality rates and reduced incidence of severe disabilities, whilst providing reliable methods and tools for patients' stratification and personalized treatments.

A Brief Case Management Intervention to Promote Personal Recovery and Prevent Psychiatric Involuntary Readmissions.

The goal of this randomized control trial is to assess the effectiveness of a Brief Case Management (BCM) intervention aimed at promoting personal recovery and reducing the negative effects of coercion among people involuntarily admitted to a psychiatric hospital. The main questions it aims to answer are : * Does the Brief Case Management intervention reduce the incidence of involuntary readmission18 months after the initial involuntary hospitalisation? * What impact does the Brief Case Management intervention have on patients' involuntary readmission 6 months after the initial involuntary hospitalisation, as well as on their personal recovery, perceived coercion, satisfaction with treatment, and on their exposure to other forms of formal and informal coercion? Participants will be randomly assigned to either the control or the intervention group, accordingly they will be asked to take part in: Control Group: * Three evaluation sessions (baseline, 6 and 18 months follow-up); Intervention Group : * Three evaluation sessions (baseline, 6 and 18 months follow-up); * The 5 sessions of the brief case management intervention (6th session optional).

Cognitive Model for Behavioral Interventions as a Personalized Intervention for Patients With Serious Mental Illness

The aim of this clinical study is to investigate whether CoMBI-SMI helps to reduce behavioral problems and psychiatric complaints in Serious Mental Illness (SMI) populations complaints and to reduce the burden on informal caregivers. It will also be examined whether there is an improvement in the quality of life of the participants. Participants are asked to complete two questionnaires. Then the participants receive treatment as is normally given in a clinical department. In particular, the caregivers will be asked to observe the behavior of the participants using a questionnaire and to follow a CoMBI-training to better tailor the treatment to the core needs of the participants. Comparisons will be made within the participant group because measurements take place before and after the procedure.

QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360)

BRIEF SUMMARY A. "What is the purpose of this study?" BACKGROUND. The QAIAx clinical trial (Quantum AI/AGI Public Health Agency), known operationally as the "AI City Hall Project," represents a landmark intergovernmental research initiative examining the viability of AI-governed residential ecosystems for behavioral and mental health intervention. Authorized under 10 U.S.C. 4001 (Defense Sector Research Projects, RDT\&E) and supported by pending USPTO applications (Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360), this non-medicinal program investigates whether quantum AI-managed public administration, AI humanoid robotics, holographic holoportation (AI-119 Kikkeri Holo-Suit / "AI Wat Beam Bot"; AI-119 Vulcan QM-Ware or "Quasi-Mind Ware"), and advanced AGI learning machines can reduce housing and care costs while improving mental health outcomes-particularly for persons with addiction and co-occurring psychiatric disorders. SCOPE \& JURISDICTION. The trial operates across a network of self-contained, geodesic dome-enclosed "Microcities" (1,500-15,000 occupants per site) within an affiliate network of 300 communities, spanning North America, South America, Europe, Africa, Oceania, Asia, and the Middle East. Participating host nations are U.S.-allied member states party to the Status of Forces Agreement (SOFA), the Vienna Convention on Diplomatic Relations, and the Hague Convention, alongside related bilateral treaties with the U.S. government. INTERVENTION \& POPULATION: Eligible adults (18+) reside in these Microcities for up to 36 months. Daily life-including housing, utilities, and healthcare-is administered by the ISAC AI/AGI system and robots with minimal human oversight. CLINICAL TRIAL GOAL(S): The clinical trial program goals are to exemplify a sustainable AGI-managed public administration supported by AI robotics and AGI trans-human and omni-AI machines (e.g., "Q-Men"; "AI-Me"; Beam Bot", "QM-Ware", "AVK Suit") to improve mental health outcomes-especially for those with addiction disorders-and create a financially sustainable model for people on fixed incomes or public assistance. B. "What conditions does the study focus on?" The study focuses on adults with: * Autism spectrum disorders (Asperger's, autism, ADHD, ASD) * Substance use disorders (alcohol, opioids, marijuana, cocaine, MDMA/ecstasy, tobacco/nicotine) * Psychiatric conditions (personality disorders, narcissism, gender dysphoria, eating disorders) * Behavioral addictions (gambling, sex addiction) and related issues (sex offence history). C. "What does the study involve?" Eligible volunteers live in an omni AI-managed Microcity for up to 24 months. The community is housed in a geodesic dome that contains all daily necessities: housing, food, utilities, healthcare, and public services. Daily life is managed by an AI system (ISAC) and AI humanoid robots, with only occasional human oversight. Participants receive free mental-health treatment that may include AI-driven counselling, virtual-reality therapy (holo-suits), and non-invasive digital "attitude inoculation" protocols designed to reduce stress and addiction cravings. All participants also take AI-technology courses as a condition of enrolment. The study does not use any FDA-regulated drug, device, or biologic. \*\*Who can participate?\*\* You may be able to join if you: * Are an adult (18 years or older) * Have a diagnosis of one of the listed mental-health or addiction disorders * Are referred by a licensed health professional (e.g., RN, NP, PhD, MD), a non-profit organization (e.g., 501(c)(3), university, church), or a public agency (e.g., case manager, social worker, parole/probation officer, judge) * Are willing to live in a closed, AI-managed community for up to one year and complete AI educational courses. Participants who are veterans, receive public assistance (e.g., VA disability, SSDI/SSI, Medicaid, Medicare), or are experiencing homelessness may be prioritized. \*\*Where is the study taking place?\*\* The study will be conducted at Microcity sites in the United States and internationally. The first administrative site is in Richmond, Virginia, USA. Additional sites are planned in partner nations, including tribal lands, military installations, and special economic zones. \*\*Who is sponsoring the study?\*\* The study is sponsored by Veterans Recovery Network Inc., a SCDV-owned non-profit organization, in collaboration with AI-119 Vulcan Project Research \& Educational Technology Co. (PRETCO). The study is conducted under U.S. federal research and development authorities (28 U.S.C. §1498; 10 U.S.C. §§§§ 4001, 4021, 4022, and 4023) and is part of a Cooperative Research and Development Agreement (CRADA) with participating segments or RDT\&E programming missions of the United States Defense Department (DoW). This summary describes a planned clinical study. Not all details may be final. Information may change as the study progresses.

Electrotherapy Stimulation Together With Life Coaching for the Support of Burnout Symptoms in Healthcare Workers

This clinical trial evaluates the effect of life coaching together with Cranial Electrotherapy Stimulation (CES) as an intervention to decrease self-reported symptoms of burnout, moral distress, resilience, and employee retention in oncology healthcare workers. Burnout and moral distress are occupational hazards for oncology healthcare workers. Emotional exhaustion, depersonalization, and lack of personal accomplishment at work are symptoms of burnout. Moral distress may be defined as knowing the right thing to do but being unable to do so based upon internal or external constraints. The device is attached to the earlobes that uses cranial electrotherapy stimulation (CES) at a microcurrent to alleviate symptoms of anxiety, insomnia, pain, and possibly depression. Life coaching is partnering with clients in a thought-provoking and creative process that inspires them to maximize their personal and professional potential and can increase resiliency skills such as boundary setting and prioritizing, increases in self-compassion and self-care, and potentially indirectly positively impact patient care. Undergoing the use of CES via the CES device, coupled with life coaching, may help alleviate burnout symptoms and moral distress in oncology healthcare workers.

Individualized Functional Connectivity Targeting in aiTBS for Depression

The goal of this clinical trial is to estimate the importance of neuroimaging in accelerated intermittent theta burst stimulation (aiTBS) for depression. Participants will receive aiTBS treatment, but they will not know if their treatment spot was found with neuroimaging or head measurements.

Evaluation of a Modularized Cognitive Behavioral Group Therapy Programme for Young Adults (CHANGE-Study)

This prospective, non-randomised, pre-post feasibility study evaluates CHANGE, a novel 8-session modularized cognitive behavioral group psychotherapy for young adults (18-25 years) with psychiatric disorders receiving inpatient or day-care treatment. All eligible participants (planned n=30) receive the intervention in addition to treatment-as-usual; there is no control arm. The primary aim is to assess feasibility, acceptability and appropriateness of the intervention (SMI (a German scale for feasibility), SAI (a German scale for acceptability), AIS (a German scale for appropriateness) scales; recruitment, retention, adherence and dropout rates). Secondary outcomes include perceived competence, self-efficacy (SWE), motivation (FEVER), satisfaction, quality of life (WHOQOL-BREF) and level of functioning (GAF), assessed before (T0) and after (T1) the intervention.

Prevalence of Suicidal Risk in Psychiatric Settings

France is among the countries with one of the highest suicide rates in the world, far ahead of its neighboring nations \[Wasserman et al., 2012\]. Suicide represents the second leading cause of death among 15-24-year-olds, just after road accidents, and the leading cause of death among 25-34-year-olds. In this context, a better utilization of all components of the healthcare system seems highly desirable, particularly through greater involvement of community psychiatrists in suicide prevention strategies. Approximately 25% of individuals who die by suicide have consulted a psychiatrist in the month preceding their death \[Luoma et al., 2002\], yet few data are available on this topic, especially regarding consultations with community psychiatrists outside of hospital settings. Study objectives Main objective To assess the prevalence of suicidal risk during the 15 days preceding an outpatient psychiatric consultation in the Clermont-Ferrand area. Main secondary objectives * To describe the recruited population and potentially associated factors (age, sex, etc.). * To assess the psychological pain of these individuals over the same period when suicidal thoughts are strongest, or, if absent, when they feel at their worst. * To assess the self-esteem of these individuals over the same period when suicidal thoughts are strongest, or, if absent, when they feel at their worst.

Prevalence of Brief Suicidal Crisis in Psychiatric Settings

France is among the countries with one of the highest suicide rates in the world, far above those of its neighboring countries \[Wasserman et al., 2012\]. Suicide is the second leading cause of death among 15-24-year-olds, just after road traffic accidents, and the leading cause of death among 25-34-year-olds. Current models emphasize the variability of suicidal trajectories and the possible fluctuation in the duration of suicidal crises: for some individuals, the crisis evolves rapidly and explosively (brief), whereas for others, distress becomes more chronic, often in connection with underlying psychiatric disorders \[Stanley, Brodsky, and Monahan, 2023\]. In this context, the concept of a 'brief suicidal crisis' is an emerging one in psychiatry. It is characterized by an acute phase of psychological vulnerability, during which the main risk is progression to suicidal behavior, but it remains a temporary and reversible psychic crisis (lasting less than 24 hours). The crisis state is marked by a sudden inability to mobilize one's usual coping resources in the face of difficulties, making the individual highly vulnerable. Nevertheless, this concept has been little described, and a better assessment seems desirable, particularly in populations consulting a psychiatrist. Indeed, around 25% of people who die by suicide had consulted a psychiatrist in the month before their death \[Luoma et al., 2002\], yet few data are available on this topic. Primary objective is to assess the prevalence of brief suicidal crisis episodes (lasting less than 24 hours) over the past 12 months among patients attending outpatient psychiatric care and within a sample of patients from a population catchment area in the Clermont-Ferrand region.

Qualitative Study About Psychedelics Using in Psychiatric Disorders

This study is set up to better understand the current use of psychedelics in France in the general population. The present focus on individuals who have used any type of psychedelic drug in order to suppress or alleviate a psychiatric symptom in the context of a diagnosed pathology. The data are collected during a semi-structured interview and then studied in a thematic analysis.

Psychoeducational Course for Suicide Prevention

The plan is to include patients with a history of increased risk of suicide. In the aftermath of an episode of imminent suicide risk, patients will receive a psychoeducational course that entails information on different aspects of suicide-related topics, identifying triggers and detecting early warning signals for increased suicide risk. The course culminates in working on completing a individual safety plan to prevent an future increase in suicide risk. The course will incorporate both patients and their next of kin. The psychoeducational course will be compared to a control group where the patients receive one individual session with focus on a safety plan to evaluate the intervention. Both groups will receive treatment as usual (TAU) during both the acute phase and follow-up. The study will be conducted as a randomized controlled trial.

Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness

Participants will receive Transcranial Magnetic Stimulation (TMS) at a random location in the left prefrontal cortex, excluding sites that are potentially unsafe. Extensive behavioral testing will be conducted to determine which behaviors are modulated by stimulating which circuits.

Testing a Transdiagnostic TMS Treatment Target

The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst stimulation when it is targeting the posterior parietal cortex. Additional questions focus on whether this stimulation improves symptoms of depression and other psychiatric disorders as well as whether this stimulation changes brain function.

Psychiatric Disorder in Dysnergic Defecation

Case control observational study conducted on DD patient and healthy control group. 1. evaluate psychiatric disorders among patients with dyssynergic defecation 2. evaluate the effect of delayed diagnosis of dysnergic defecation on the quality of the life

Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents

Non-suicidal self-injury (NSSI) are acts defined by the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5) as intentional and deliberate, occurring outside a psychotic state and directly causing moderate injury. Their international prevalence is between 13 and 17% in adolescents and young adults, and has recently increased with the COVID-19 health crisis, with the prevalence of NSSI rising to 40% in adolescents. Access to psychiatrists is declining. Drug solutions, meanwhile, lack scientific proof in this indication. The autonomic nervous system and the hypothalamo-hypophyseal axis are involved in the human response to experimentally-induced pain, as well as in stress regulation, notably via control of cortisol secretion. Abnormally low levels of the latter hormone have been detected in persons with NSSI disorder. Transcutaneous neurostimulation of the atrial vagus nerve (taVNS) has been studied for some ten years. The afferent branches of the vagus nerve stimulate the hypothalamic-pituitary axis, leading to the production of cortisol by the adrenals. The hypothesis of this research is that stimulation of the vagus nerve by taVNS would improve the functioning of the hypothalamic-pituitary axis in patients with NSSI, and thus reduce the frequency of acting out. Although taVNS is an easy-to-access technique that patients can implement at home, the question of adherence to this treatment in adolescents has not yet been evaluated. The aim of this pilot study is to assess whether adolescents with NSSI will adhere to taVNS treatment.

Risk Factors, Costs, and Impacts of ED Boarding

The goal of this observational study is to learn about the risk factors, costs, and operational impacts of emergency department boarding (patients admitted to the hospital but remaining in the emergency department awaiting placement on an inpatient floor) The main questions it aims to answer is: 1. What characteristics of patients make them more likely to experience ED boarding? 2. What is the impact of ED boarding on costs of health care? 3. How do high-boarding environments affect the clinical care of all patients in the emergency department, including those that do not board themselves. Data will be secondary in nature, collected in the regular Participants already taking intervention A as part of their regular medical care for RA will answer online survey questions about their joint pain for 5 years.

Adapted Helping Ovarian Cancer Patients Cope Intervention to Address Burnout for Gynecologic Oncology Clinicians

This clinical trial tests an adapted version of the Helping Ovarian Cancer Patients Cope (HOPE) intervention to address burnout among gynecologic oncology clinicians. Stress and burnout among gynecologic oncology clinicians can have far-reaching impacts not only on physicians at the individual level (e.g., distress, mental illness) but also at the professional (e.g., worse patient outcomes, increased errors) and societal levels (fewer physicians in this specialty, more system strain). The original Helping Ovarian Cancer Patients Cope (HOPE) is a workshop to promote hope among patients with ovarian cancer through creating positive narratives using the hope theory and social-cognitive theory. The adapted intervention for clinicals (HOPE-C) will use the same concepts but tailored to clinician experiences by fostering peer support and retelling their challenging stories and may address burnout for gynecologic oncology clinicians.

Neural Correlates of Psychiatric Disorders

This ClincialTrials.gov record originally corresponded to the protocol approved under IRB # 202370. The study was expanded to include stimulation and recordings approved under new IRB #211037. The participant data originally acquired from IRB# 202370 will be included in this new record: This study seeks to better understand the neural activity underlying neuro cognitive disorders. Resting state local field potential recordings will be collected from medically refractory epilepsy patients implanted with depth electrodes for seizure localization, and metrics of neural activity will be correlated with psychiatric symptoms as measured from questionnaires. Subjects will also participate in neuro cognitive tasks while neural recordings are performed, and/or receive neural stimulation through implanted depth electrodes. A better understanding of disordered neural activity underlying neuropsychiatric disorders may additionally contribute to novel methods for diagnosing, treating, and preventing these diseases.

External Facilitation to Increase Prescribing of AUD Medications in the Psychiatric Setting

This project will pilot test an implementation facilitation intervention to increase prescribing of medications for alcohol use disorder (MAUD) in patients with major mental illness and alcohol use disorder in three psychiatry treatment clinics.

Effects of Delayed School Start Times on Sleep, Mental Health, and Academic Performance Among Norwegian Adolescents

The aim is to investigate whether later school start times have positive effects on high school students' sleep patterns, mental health and daytime functioning.

Digital Versus Telephone Symptom Assessment and Triage in Primary Care

A 'digital-first' approach is currently under implementation in several Swedish regions. The principles behind implementing an online service as an access way to primary care are based on an expectation that it can make access easier, direct people to appropriate levels of care, and increase both availability of heath care and cost efficiency. However, a recent Swedish report concluded that digital triage in primary care has not been investigated in a clinical real-world setting, including real patients, meaning that the benefits and risks for patients as well as on a system level remain unclear. The aim of this trial is to study the feasibility of a larger trial that will compare digital triage and traditional telephone triage on adherence to triaged health care level, in a randomized controlled study (feasibility study, RCT). The study will recruit a total of 120 patients, of which half will be randomized to telephone triage and half to digital triage.

The Pilot Study "Home Treatment in Child and Adolescent Psychiatry" Aims to Evaluate the Effectiveness of a 3-month Home-based Intervention as an Alternative to an Inpatient Stay at a Psychiatric Clinic. Participants Are Children and Adolescents With Current Psychiatric Conditions.

This study investigates the effectiveness of an intervention for children and adolescents with psychiatric disorders. The core concept is the provision of treatment in the patient's home environment as an alternative to, and substitute for, inpatient psychiatric care. Patients receive between 3 and 7 treatment sessions per week over a period of 3 months. A multidisciplinary team-comprising a physician, psychologist, social worker, occupational therapist, dietitian, and educational specialist-delivers assessments and interventions on site. Participation in the program is offered as a voluntary alternative to hospitalization. The study is designed as a single-arm pragmatic trial. The primary outcome is the change in clinical symptom severity and psychosocial functioning, as assessed by the study physician. A follow-up assessment will be conducted after 6 months to evaluate long-term effectiveness. In addition to the primary outcome, both patients and their legal guardians provide self-reports on psychosocial functional impairment. Changes in functional impairment constitute the secondary outcome. For comparative purposes, outcomes will be contrasted with a historical control group consisting of inpatient participants.