Personality disorders encompass a group of mental health conditions characterized by enduring patterns of behavior and inner experiences that differ significantly from cultural expectations. Clinical trials for personality disorders explore treatment...
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Found 246 Actively Recruiting clinical trials
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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.
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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.
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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.
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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 Veterans 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.
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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.
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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.
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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 Alzheimers 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 drugs 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.
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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 skillscognitive restructuring, opposite to emotion action, or mindfulnessthat 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.
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This research aims to evaluate a new brief and individually tailored behavioral parent training program designed for children aged 2 to 12 who experience behavioral difficulties such as oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behaviors. The study compares the short- and long-term effectiveness and cost-effectiveness of this brief parent training with optional booster sessions against the usual care provided by mental healthcare centers. The trial is conducted as a two-arm, multi-center randomized controlled trial embedded within routine mental healthcare settings. Parents in the intervention group receive a three-session training program two sessions of two hours each, delivered biweekly, followed by a one-hour session for evaluation and maintenance. Afterward, they may opt for additional booster sessions, each lasting one hour and offered up to once every four weeks for one year. The control group receives care as usual, which may include psychoeducation, parent counseling, long parent training, child therapy, or family therapy, with no restrictions on type or duration except exclusion of the brief program. Participants provide information on child behavior, well-being, parenting behaviors, and stress through questionnaires, audio recordings of mealtime routines, and daily phone calls at four timepoints baseline, shortly after the intervention or equivalent time for controls, six months later, and twelve months later. Researchers measure changes in specific behavioral difficulties parents aim to address, alongside secondary outcomes like child well-being and parenting stress. Therapists and parents evaluations of the program are also collected. The study monitors adherence and intervention fidelity through audiotaped sessions and supervision. Participation lasts up to one year with regular assessments.
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This research aims to improve mental health treatment for autistic individuals by developing and testing a toolkit for therapists. The study is divided into two phases first, remote focus groups with autistic individuals and licensed therapists will explore barriers to mental health care and ways to enhance it. The goal is to create a resource that helps therapists adapt evidence-based treatments for autistic clients. In the second phase, therapists at a community clinic will be randomly assigned to either continue their usual psychotherapy approach or to use the new toolkit while treating autistic adolescents. This toolkit includes strategies designed to improve therapists knowledge, confidence, and the quality of care they provide. The study will compare outcomes between the two groups over time. Participants will include autistic adolescents aged 13 to 17 with co-occurring mental health conditions, and therapists from the community clinic. The study will collect data through measures of intervention acceptability, feasibility, and appropriateness at baseline and one month. Additional assessments will examine therapist knowledge, confidence, client satisfaction, goal attainment, and clinical impressions up to four months. The study will run from April 2026 to December 2027.
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