Obsessive-Compulsive Disorder (OCD)

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.

Suicide is the second leading cause of death among youth, and rates in the US are rising despite prevention efforts. Researchers are evaluating a digital platform called Vira to improve how care is delivered to adolescents at high risk for suicide. This platform aims to use smartphone data and secure communication tools to better understand and manage risk factors like psychological distress, anhedonia, behavioral withdrawal, and sleep problems in young people receiving intensive outpatient treatment. The study compares two groups of adolescent patients aged 13 to 18 years old who are in an intensive outpatient Dialectical Behavior Therapy DBT program. One group uses the Vira platform, which collects data passively from smartphone sensors about activity, sleep, mobility, and mood-related language. Vira also prompts daily check-ins and supports practitioners with reminders to encourage behavior changes. The other group receives the usual treatment with the addition of a passive monitoring app called EARS. Participants will use their assigned app during their intensive outpatient treatment. Researchers will assess outcomes using tools like the Columbia Suicide Severity Rating Scale and Scale for Suicidal Ideation over six months. Other measures include anxiety, risky behaviors, sleep quality, mood, and pleasure scales at three and six months. The study monitors clinical outcomes to determine if the digital platform enhances care for youth at risk of suicide.

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.

Researchers are evaluating the effectiveness and feasibility of Narrative Enhancement and Cognitive Therapy NECT, a group-based treatment designed to reduce self-stigma in people with mental disorders. Self-stigma involves internalizing negative stereotypes which can harm treatment adherence, self-esteem, quality of life, and increase despair or suicide risk. This pragmatic, multicenter, randomized controlled trial includes 416 patients from 26 mental health centers in Northeast Italy, aiming to improve psychological outcomes like self-esteem, hope, empowerment, recovery perception, and mental well-being. Participants in the intervention group will attend 20 one-hour NECT group sessions divided into five parts orientation, psychoeducation, cognitive restructuring, narrative enhancement, and conclusion. The therapy helps challenge stigmatizing beliefs and fosters a positive self-narrative. This group therapy is provided alongside participants usual care, which may include medication and psychosocial treatments. The control group will continue their standard care without NECT. The study lasts about 12 months, with a 2-month recruitment phase, 5 months of intervention, and 5 months for data analysis and publication. Participants will undergo assessments at enrollment and after the 20-week intervention to measure changes in self-stigma, self-esteem, hope, empowerment, recovery perception, mental well-being, and stigma-related stress. Treatment fidelity will be monitored through session recordings. The study also tracks feasibility by evaluating participation rates and feedback. All participants remain under their usual care throughout the study, and data collection includes monitoring care received during the trial.

Researchers are evaluating the ViraSafe app, an enhanced version of the BRITE suicide safety planning app, to improve engagement with coping skills and safety planning among suicidal adolescents aged 13 to 24. This pragmatic randomized trial compares the new ViraSafe app integrated into the Vira behavior change platform with the original BRITE app, aiming to address rising youth suicide rates by using digital tools for intervention. The study focuses on youth who have experienced recent suicidal thoughts or attempts and are receiving care in clinical settings. Participants are randomly assigned to use either ViraSafe or BRITE. ViraSafe integrates safety planning and coping skills into a smartphone app with automated just-in-time reminders and daily distress ratings, supported by clinicians who can send additional nudges. The BRITE app offers self-monitoring, a safety plan, distress level ratings, and suggested coping activities based on distress. Both groups onboard the assigned app with a trained clinician or research staff. The trial lasts three months with assessments at baseline, one month, and three months. Participants complete virtual assessments including interviews and self-report measures at baseline, one month, and three months. Some participants using ViraSafe will take part in qualitative exit interviews for feedback. The study collects data on app engagement, technology acceptance, and suicide risk factors using standardized tools. Safety plans remain accessible throughout, and mental health indicators are monitored through self-reports and passive smartphone data. The total participation time is about three months, with ongoing support from clinical providers.

Researchers are evaluating a lifestyle intervention aimed at improving health habits and reducing cardiometabolic risk factors in adults with obsessive-compulsive disorder OCD. This condition is linked to higher risks of heart and metabolic diseases, partly due to unhealthy lifestyle behaviors. This trial is the first randomized controlled study to assess the effectiveness and cost-efficiency of such an intervention for people with OCD. Participants are randomly assigned to one of two groups. The first group receives a 13-week lifestyle program including one personal session to set goals, followed by 12 weekly group sessions combining education on healthy habits and physical exercise. After these sessions, they get access to a digital booster module to maintain changes. The second group receives one individual session with feedback on their health and written advice on healthy lifestyle habits based on national guidelines. During the study, participants will wear accelerometers to measure physical activity, and assessments will take place at the start, after 14 weeks, and at 12 months to track changes in activity, diet, mental health, and cardiometabolic markers. Questionnaires and physical measurements will be used to evaluate outcomes such as stress, sleep, OCD symptoms, quality of life, and various blood tests. Safety and cost-effectiveness will also be monitored throughout the trial period.

Researchers are evaluating a mentalization-based prevention program aimed at improving well-being and mental health in children aged 8 to 10 years and their families across four European countries Germany, Lithuania, Spain, and Switzerland. The study is designed as a partially randomized controlled trial and investigates how multi-level interventions involving children, parents, and teachers can promote mental health, reduce stigma, enhance help-seeking behavior, and improve classroom climate and parenting skills. The program includes a universal prevention workshop delivered at schools for all children, focusing on mental health awareness and peer support skills. Parents receive one of two different intervention trainings or a parenting guidebook one group attends 10 weekly sessions of the Lighthouse Program targeting secure attachment and reflective parenting behaviors, and another group participates in 6 bi-weekly Mentalization Based Skills Training sessions focusing on attentional control and emotion regulation. An active control group receives a parenting guidebook, while a passive control group participates in follow-up assessments without intervention. Participants will be involved in data collection at multiple time points baseline, post-intervention at 3 months, and follow-ups at 6 and 12 months. Assessments include questionnaires measuring childrens and parents well-being and mental health, parental efficacy and stress, classroom climate, teaching efficacy, and mental health stigma. Focus groups after the post-assessment will gather feedback on implementation and satisfaction. The study aims to follow 5,000 children, their parents, and teachers over a year to evaluate long-term program effects.

Researchers are investigating the effects of a multidomain lifestyle intervention to slow cognitive decline and dementia risk in elderly residents aged 60 to 80 in Zhejiang Province, China. The study builds on findings from Finland, where a similar approach combining physical activity, nutrition, cognitive training, social activities, and vascular risk management showed promise in healthy older adults at risk of cognitive decline. This trial aims to explore how such an intervention may change brain structure and function as well as cognitive abilities in an Asian population. Participants are randomly assigned to either a structured multidomain intervention group or a self-guided control group. The intervention group receives tailored nutritional guidance, cognitive training, physical exercises, and vascular risk monitoring, all adapted to Chinese cultural norms. The control group receives regular health education campaigns and basic health monitoring every 6 to 12 months. This trial runs for two years with ongoing assessments to evaluate the impact of these lifestyle changes. During the study, participants undergo various evaluations including cognitive tests measuring global and domain-specific cognition, neuroimaging scans like MRI and fMRI, laboratory blood tests, and physical performance measures such as grip strength and gait speed. Questionnaires assess quality of life, depression, sleep quality, and daily activities. Researchers also monitor cardiovascular health, dementia onset, and falls. This comprehensive monitoring will help determine the interventions effects on brain health and daily functioning over the 24-month period.

Researchers are evaluating the effects of a smartphone-based Healthy Lifestyle HLS intervention on the mental and physical health of firefighters in Tainan, Taiwan. This cluster randomized controlled trial aims to determine if the Traditional Chinese version of the HLS mobile app can improve firefighters health compared to usual care. The study also seeks to find out whether the intervention can promote a healthier lifestyle and reduce the risk of chronic non-communicable diseases among firefighters. Participants will be randomly assigned to either the intervention group, which uses the Traditional Chinese HLS mobile app designed specifically for firefighters, or the control group, which receives usual care. The intervention period lasts from 3 to 6 months, during which firefighters in the intervention group will use the app to support healthier behaviors. The control group will continue with their standard practices without the app. Throughout the study, firefighters will undergo health and fitness assessments at the start and again 3 to 6 months after the intervention begins. Measurements include blood pressure, depressive symptoms, PTSD symptoms, body mass index, smoking habits, diet patterns, physical activity levels, sitting time, sleep duration and napping frequency, glycated hemoglobin, lipid profiles, C-reactive protein, and physical performance. The study will monitor these outcomes to assess changes in mental and physical health. Safety and progress will be observed through these regular evaluations during the study period.

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.