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-sberg 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 interventions preliminary effectiveness.

This research aims to assess the feasibility and acceptability of the Conquer Fear Carer Brief, a short psychological support program delivered online for caregivers of patients with metastatic prostate cancer. The study focuses on reducing fear of cancer progression among caregivers and evaluates treatment dropout rates, consent rates, recruitment success, and changes in fear levels using specific questionnaires. It also measures therapist adherence and participant satisfaction to understand how well the intervention is delivered and received. The intervention consists of three online sessions conducted over 3 to 4 weeks by a psychologist or psychology masters student. The sessions introduce techniques from metacognitive therapy, such as Detached Mindfulness and Attention Training, to help caregivers manage their thoughts and fears. Participants practice these techniques at home between sessions through assigned homework. The study includes a pre-intervention waiting period to compare changes before and after the intervention. Participants complete self-report questionnaires at several time points enrollment baseline, after a three-week waiting period, one week post-intervention, and 12 weeks post-intervention. Assessments include fear of cancer progression, anxiety, distress, well-being, sleep health, and other psychological measures. The study also monitors treatment adherence, satisfaction, and any negative effects. Participation lasts about 22 weeks from baseline to final follow-up.

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

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-BFM 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-BFM 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.

This research aims to understand how psychedelics might help treat symptoms of depression and anxiety in people diagnosed with major depressive disorder MDD experiencing moderate to severe symptoms. The study focuses on CYB003, a synthetic form of psilocin the active part of psilocybin, to explore its effects on brain activity and connectivity, as well as symptom changes. It is a randomized, double-blind, placebo-controlled Phase 2 trial involving adults aged 21 to 65 with ongoing depressive and anxiety symptoms despite current antidepressant treatments. Participants will be randomly assigned to receive one oral dose of either 16 mg of CYB003 or a placebo orange drink. Psychological support is provided before, during, and after the dosing session. Assessments occur at baseline, 2 days, and 21 days after dosing and include brain scans EEGEMG and MRI, clinical rating scales for depression and anxiety, cognitive tests, questionnaires about psychedelic effects, and blood tests for biomarkers. During the study, participants will complete interviews and self-report questionnaires to track symptom changes. Brain activity and connectivity are measured using functional MRI and EEG. Safety and symptom effects are monitored through clinical scales such as MADRS and HAM-A. The study measures changes at 24 hours and 21 days after dosing to understand short- and longer-term effects. The trial is expected to continue until November 2028, with participant involvement spanning the dosing and follow-up assessments.

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 participants 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.