Personality Disorder

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.

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 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.

Veterans face a heightened risk of suicide during the first year after leaving military service, especially those not connected to VA healthcare. This research aims to improve reintegration and reduce suicide risk for recently transitioned Veterans by evaluating STEP-Home-SP, a skills-based, video telehealth workshop. It is designed to provide suicide prevention education, support for accessing VA care, and tools to manage the transition effectively during this critical period. The study compares two groups: one participating in the STEP-Home-SP workshop and the other receiving Enhanced Usual Care (EUC), which includes standard care plus an educational packet on suicide risk and VA care connection. STEP-Home-SP involves weekly 1.5-hour group sessions over 12 weeks, focusing on emotional regulation, problem solving, and attention training, with up to six additional 30-minute individual sessions tailored to each Veteran's needs. EUC involves existing transition support programs such as the Transition Assistance Program and VA Solid Start outreach. Participants will be assessed at multiple points over a year, including baseline, 12 weeks, and 24 weeks. Researchers will measure feasibility factors like recruitment and adherence, satisfaction with the program, and changes in reintegration status using the Military-to-Civilian Questionnaire. They will also monitor engagement with VA care and collect qualitative feedback. The study will help inform future larger trials and aims to address social isolation and suicide risk during Veterans' transition to civilian life.

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 intervention's effects on brain health and daily functioning over the 24-month 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.

Borderline Personality Disorder (BPD) is a common and serious psychiatric condition that affects millions worldwide, leading to significant difficulties in daily life and high rates of suicidal thoughts and actions. Young women are especially at risk, with BPD being diagnosed three times more often in women than men. The causes of BPD are complex, involving both biological and environmental factors such as abuse and family issues, which contribute to emotional and behavioral challenges. Currently, no medications are specifically approved to treat BPD effectively, and many patients struggle with existing treatments due to side effects or lack of response. Researchers are evaluating a novel drug that blocks a brain receptor called NMDA, which has been approved for Alzheimer's disease and is being studied for other psychiatric conditions. In this trial, 150 adults with BPD will be randomly assigned to receive either the study drug at a dose of 20 mg daily or a placebo, in addition to their current antipsychotic treatment, for 12 weeks. The trial is double-blind, meaning neither participants nor researchers know who receives the drug or placebo, to fairly assess the drug's effects. Participants will be closely monitored throughout the study with regular assessments of their borderline symptoms and cognitive function using specific rating scales at multiple time points over 12 weeks. Safety and tolerability will also be observed. This thorough evaluation aims to determine whether adding this novel drug can improve symptoms and functioning in people living with BPD during and at the end of the treatment period.

Researchers are evaluating whether teaching people personalized versus standardized emotion regulation skills can better reduce daily negative emotions. The study also aims to see if matching participants to their predicted best skill training is feasible and helpful. This research may reveal how emotion regulation treatments impact emotional health and help develop personalized, evidence-based, and scalable interventions. Participants will be randomly assigned to learn one of three emotion regulation skills—cognitive restructuring, opposite to emotion action, or mindfulness—that matches their personal strengths, or to learn all three skills through interactive videos with surveys to practice and check understanding. These training conditions are designed to compare focused versus broad skill coverage. During the study, participants will report their emotions multiple times daily for 42 days, using the Positive and Negative Affect Schedule-Short Form. They will also complete assessments every two weeks for six weeks, measuring depression, anxiety, personality traits, responses to emotions, and breath-counting tasks. Researchers will monitor changes in emotion regulation effectiveness and emotional experiences to understand the impact of the training.

Researchers are evaluating a brief and individually tailored behavioral parent training program for children aged 2 to 12 years who have behavioral difficulties such as oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behaviors. The study aims to compare this new short parent training with care as usual (CAU) in mental healthcare centers, focusing on both short- and long-term effectiveness and cost-effectiveness. The trial addresses current challenges like limited access to certified therapists and high dropout rates due to the length and rigidity of standard programs. Parents in the intervention group participate in three sessions over three to four weeks: two individually tailored sessions lasting two hours each, followed by a one-hour evaluation and maintenance session. Optional booster sessions are available once every four weeks for up to one year after the program to help maintain improvements. The control group receives usual care, which may include psychoeducation, counseling, longer parent training, medication, or family therapy. Both treatments are delivered within routine Dutch mental health care, and therapists receive specialized training and supervision to deliver the brief program. Participants provide information and complete various assessments at baseline, one week after treatment, six months, and twelve months later. These include parent questionnaires, audio recordings of mealtime routines, and daily phone calls to monitor child behavior, parenting stress, and parent-child relationships. Researchers also evaluate program feedback from parents and therapists, treatment costs, and health utilities. The total participation spans about one year, with careful monitoring to ensure treatment fidelity and ethical standards.

Researchers are evaluating how well adults with borderline personality disorder (BPD) or attention deficit/hyperactivity disorder (ADHD) tolerate a medicine called BI 3031185. The study includes separate groups for people with BPD and ADHD and aims to assess safety, tolerability, pharmacodynamics, and pharmacokinetics through a randomized, double-blind, placebo-controlled design. Participants take part in two sequences: one group receives a single dose of BI 3031185 followed by placebo after a two-week break, while the other group receives placebo first then BI 3031185. Both treatments are given as tablets. The study lasts about 1 to 2 months, with several visits including overnight stays at the study site. During the 6 in-person visits and 3 phone or video calls, doctors monitor participants' health and check for any unwanted effects. The main outcomes measured are the number of participants reporting adverse events related to the medicine. Safety and tolerability are closely observed from the time of dosing until the end of the study.