Generalized Anxiety Disorder (GAD)

Researchers are evaluating erectile function changes in male patients who undergo percutaneous coronary intervention (PCI) for either a heart attack or stable angina. The study aims to understand how myocardial infarction affects erectile function over time and to explore whether erectile dysfunction can predict future cardiac events. This observational study compares erectile function between patients with myocardial infarction and those with stable angina using standardized questionnaires. Participants are grouped into two sets: those treated with PCI after a heart attack and those treated due to stable angina. Erectile function is assessed at baseline (after recovery from PCI), and at 3 and 6 months post-procedure using the International Index of Erectile Function (IIEF) questionnaire. Additional assessments include the Beck Depression Inventory and Fear of Cardiac Recurrence and Progression Scale. Researchers also collect clinical data such as cardiac vessel scores, ejection fraction, testosterone levels, body measurements, medication use, and the intervention method. During the study, male participants aged 30 to 75 will complete face-to-face interviews and questionnaires at specified intervals: baseline, 3 months, and 6 months after PCI. The study measures changes in erectile function scores over time and examines associations with cardiac health, depression, and anxiety symptoms. Safety and participation are monitored throughout the follow-up period. The total duration of involvement is up to 6 months, with evaluations focusing on erectile function and related health parameters.

This observational study investigates the relationship between tongue color features and anxiety-depression levels in patients receiving acupuncture. Researchers aim to see if tongue photographs taken with standard smartphone cameras can predict scores on the Montgomery-Åsberg Depression Rating Scale (MADRS), which measures anxiety and depression severity. The goal is to explore a new, non-invasive way to assess mental health using machine learning analysis. Participants will have their tongues photographed using an iPhone under standardized conditions to ensure consistent lighting and positioning. They will also complete the MADRS questionnaire during a routine acupuncture visit. No treatments or invasive procedures will be changed or added during the study. The collected data will be analyzed with machine learning methods to identify patterns between tongue color and anxiety-depression scores. During the study, participants only need to attend one visit where tongue images and questionnaire responses are collected. Researchers will measure the correlation between tongue color metrics and MADRS scores at this single timepoint. There are no additional treatments or follow-ups required. The study uses everyday technology to make this assessment easy and accessible in clinical settings, aiming to improve early detection and monitoring of anxiety and depression.

Researchers are evaluating a community health worker-delivered mental health counseling intervention delivered remotely via a mobile health app to reduce anxiety and depression among people living with HIV in Florida. This pilot randomized controlled trial aims to assess the preliminary effectiveness of this adapted positive affect counseling approach compared to the standard version of the app and usual mental health care. The study is sponsored by the University of Florida and focuses on improving mental health outcomes in this population. Participants will be randomly assigned to one of two groups. The intervention group will receive approximately five weekly 60-minute individual counseling sessions via secure video calls through a modified PositiveLinks app that includes enhanced mental health resources. If symptoms do not improve, participants may be referred to a licensed mental health professional. The control group will use the standard PositiveLinks app, which provides feedback on anxiety and depression symptoms and a list of local mental health resources without counseling. During the study, data will be collected from participants' electronic medical records and the app for about six months after enrollment. Researchers will measure changes in anxiety and depression levels at three months as primary outcomes. Participants will provide informed consent before joining, and there is no masking or blinding in the trial. The study will monitor mental health symptoms and the use of counseling through app data and medical records to evaluate the intervention's preliminary effectiveness.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

Researchers are comparing two school-based programs, Facing Your Fears-School Based (FYF-SB) and Zones of Regulation (ZOR), to see which is more effective at reducing anxiety and improving emotion regulation in autistic students aged 8 to 14 years. This study focuses on autistic youth who experience anxiety and aims to help schools better support their mental health, especially students from underserved communities. The trial will also assess how well each program is accepted by students, caregivers, and school providers. The study involves 200 autistic students with anxiety who will be randomly assigned to one of the two programs for 12 weeks. FYF-SB uses cognitive-behavioral therapy (CBT) strategies focused on anxiety reduction through psychoeducation and gradual exposure to fears. ZOR teaches students to recognize and manage emotions by categorizing feelings into four "zones" using color codes and providing strategies to regulate emotions. Trained school providers will deliver the programs to small groups of students in their schools. Participants will be evaluated before and after the intervention, with a follow-up six months later. Assessments include anxiety and emotion regulation measures completed by students, caregivers, teachers, and independent evaluators. The study will also track school attendance, disciplinary actions, academic participation, and satisfaction with the programs. Researchers will examine treatment effects and gather feedback through surveys and interviews to understand how feasible and acceptable each program is in school settings.

Research on personality disorders (PDs) in older adults is limited despite these disorders being common in this age group and often co-occurring with other mental and physical conditions. Current diagnostic criteria mainly fit younger adults, so this study evaluates new dimensional models for PDs called the Alternative Model for Personality Disorders (AMPD) and the ICD-11 approach. Researchers aim to assess if these models are appropriate and clinically relevant for older adults by comparing younger and older populations and studying older clinical patients. Participants include younger adults (18-64) and older adults (65+) from the general population who complete questionnaires. Older adults in clinical settings with various psychological conditions will also take questionnaires, and a smaller group will undergo clinical interviews. The study uses two main questionnaires: the LPFS-BF 2.0 measuring personality functioning, and the PID-5-BF+M measuring personality traits. Additional standard tests and clinical ratings will be collected in the clinical population. Participants will complete questionnaires in person, with some clinical participants providing informant reports from family or friends. Researchers will analyze questionnaire results for validity, age-neutrality, and clinical utility. The primary outcomes are scores from the PID-5-BF+M and LPFS-BF 2.0 collected about one month after admission, with clinical ratings and additional measures collected during hospitalization and follow-up. The study involves ongoing monitoring to understand PD structure and characteristics in older adults and improve care.

Researchers are developing and testing a culturally adapted mobile health application aimed at Black individuals who engage in hazardous drinking and experience clinical anxiety. This study evaluates a personalized feedback intervention (PFI) designed to increase knowledge about the harmful relationship between anxiety and alcohol use, motivate reduction in risky drinking, and change attitudes towards anxiety-related alcohol consumption. The intervention is delivered through a brief, single-session mobile application available on Android and iOS platforms. Participants complete a 45-minute session at the start and then have access to the app's materials for up to three months. The app was created with expert input and usability testing from Black hazardous drinkers with clinical anxiety to ensure cultural relevance and ease of use. Participants will take part remotely, with initial screening and baseline assessments conducted via Zoom. Follow-up data will be collected remotely at one week, one month, and three months after the intervention. Researchers will measure changes in alcohol use, anxiety severity, motivation to reduce drinking, drinking motives, and alcohol attitudes to assess the app’s feasibility, acceptability, and initial effects.

Researchers are evaluating the effectiveness and safety of lemborexant, a new dual orexin receptor antagonist, in treating adults with mental disorders complicated by insomnia. This observational study focuses on patients aged 18 and above who meet the DSM-5 criteria for mental disorders and have an Insomnia Severity Index score of 11 or higher. The study aims to provide real-world evidence for optimizing treatment plans for insomnia alongside psychiatric conditions. Participants will receive lemborexant tablets taken orally before bedtime, starting at 5 mg per day, which may be increased to 10 mg based on clinical response and tolerance. The treatment period lasts 8 weeks, including a baseline assessment week and 8 weeks of active treatment. Patients who are using benzodiazepine receptor agonists at the start are recommended to gradually reduce and stop these within the first 4 weeks. The study is single-arm and prospective, with all participants receiving lemborexant. During the study, participants will complete various assessments including the Insomnia Severity Index, Sleep Satisfaction VAS, and Epworth Sleepiness Scale at baseline, week 4, and week 8. Researchers will monitor changes in insomnia symptoms, treatment retention, benzodiazepine discontinuation rates, dose adjustments, and adverse events. The total duration of participation is approximately 8 weeks, with follow-up to observe symptom improvement and safety outcomes.

Researchers are evaluating a neuro-technological approach to help adolescents diagnosed with Generalised Anxiety Disorder (GAD). The study aims to test the safety and acceptability of delivering a mindfulness-based anxiety regulation intervention through a virtual reality (VR) game combined with neuro- and bio-feedback. This intervention uses a novel algorithm designed for early treatment of GAD in outpatient adolescents aged 13 to 18 years. Participants will take part in eight intervention sessions lasting 30 minutes each, held twice a week over four weeks. During these sessions, they will wear a head-mounted VR display and a mobile EEG-biosensor, both non-invasive devices. Each session starts with audio-guided mindfulness practice, followed by a 15-minute VR game that adapts to the participant's anxiety levels and their ability to manage it. Participants will continue their usual psychiatric treatment except for changes in psychotropic medications. Throughout the study, participants will complete questionnaires at the beginning and end of the intervention. Researchers will assess outcomes including usability of the intervention at week 4 and anxiety levels reported by both the adolescents and their parents at baseline and after five weeks. The study monitors participant safety and intervention feasibility over the four-week treatment period.

Researchers are evaluating whether a new blood biomarker can help identify depression and schizophrenia in patients attending psychiatric clinics. The study aims to see if changes in this biomarker can distinguish depressed patients who respond to treatment from those who do not, and differentiate individuals having a first psychotic episode from those at risk of developing schizophrenia. This observational study involves up to 500 participants grouped by diagnosis into Depression (DEP) and Psychosis/Schizophrenia (PSY) arms. Participants will attend three study visits over six months, during which blood samples and standard mental health assessments will be collected. These visits will help researchers analyze the relationship between the biomarker characteristics and the mental health conditions. The study does not involve any treatments but focuses on monitoring and measuring the biomarker and clinical factors over time. During the study, participants will complete standardized mental health questionnaires at each visit, and researchers will collect blood samples to study the biomarker changes. The main outcomes measured include the relationship between depression or psychotic disorders and biomarker characteristics over the six-month period. Researchers will also explore how clinical and demographic factors relate to these biomarker changes. The total participation time spans about six months with three scheduled visits.