Delusional Disorder

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 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 a peer-delivered recovery program called SUPPORT for Veterans with serious mental illness SMI, such as psychotic or bipolar disorders, who are at increased risk for suicide. The study aims to refine and pilot this intervention, which focuses on helping Veterans identify warning signs, develop wellness tools, and create personalized recovery plans to improve functional and social recovery and reduce suicidal thoughts. This study is conducted in two phases, including a pilot randomized controlled trial comparing SUPPORT with enhanced standard care. The SUPPORT intervention involves weekly 50-minute sessions led by a Peer Specialist who works closely with Veterans after a mental health evaluation. The Peer Specialist helps create a personalized suicide-focused recovery plan tailored to the Veterans experiences, using cognitive learning strategies to enhance safety plan recall and recovery. The comparison group receives enhanced standard care, which includes suicide risk assessments, safety planning, mental health referrals, and follow-up contacts. The study includes training Peer Specialists and gathering feedback from both Veterans and Peer Specialists. Participants will be assessed at baseline, mid-treatment, post-treatment, and three months after treatment using various questionnaires and interviews to measure recovery progress, suicidal ideation severity, and satisfaction with the intervention. Outcomes include feasibility of recruitment and retention, acceptability of SUPPORT, and changes in suicide ideation and personal recovery. The study lasts approximately five years, with ongoing monitoring and data collection throughout the intervention and follow-up periods.

Researchers are evaluating the effects of Resilience Training in college students aged 18 to 30 who have elevated risk factors for serious mental illnesses and experience psychotic symptoms. This study compares Resilience Training to another group program called Life Skills Training to see which better reduces symptoms and improves long-term mental health and academic success. The research also explores how the training impacts emotional responses and brain function related to psychosis. Participants will be randomly assigned to one of two four-week programs with weekly 90-minute group sessions. The Resilience Training group learns skills in mindfulness, self-compassion, and understanding thoughts and feelings. The Life Skills Training group receives information on practical topics like financial literacy, health, and safety. Both programs are designed to be active and time-matched to compare their effects. During the study, participants will complete a variety of assessments at baseline, 4 weeks, 6 months, 12 months, and 24 months. These include questionnaires measuring symptoms, mood, anxiety, suicidality, social functioning, and resilience, as well as brain imaging at selected time points. Researchers will also track academic performance and healthcare use. The study includes ongoing monitoring to evaluate changes in symptoms and overall functioning over two years.

Researchers are evaluating a mentalization-based parenting program called the Lighthouse MBT Parenting Program for parents with various mental disorders who are receiving adult mental health services. This trial compares this program to the usual care provided to these parents. The goal is to study both the short- and long-term effects of this intervention on parenting stress and related outcomes, addressing the high need for evidence-based support for parents with mental health conditions and their children. The study involves two groups one receives the Lighthouse MBT Parenting Program, which includes a preparatory individual session followed by twelve weekly group sessions of two hours each. The other group receives care as usual, consisting of one or two sessions with family members, commonly offered in adult mental health services. Both interventions are provided alongside the participants regular outpatient treatment. Participants will be assessed at the start of the study and again at 6, 12, and 24 months after starting the program. The research team will measure parenting stress using a standardized index and evaluate other factors such as childrens psychological adjustment, family functioning, quality of life, parenting competence, and the severity of psychiatric symptoms. The study includes careful follow-up to monitor these outcomes over two years.

This research aims to evaluate whether a new brief talking therapy called TRUST is suitable and can be successfully provided to adolescents aged 16 to 18 who experience paranoia and seek help from Child and Adolescent Mental Health Services CAMHS. Paranoia involves strong fears that others intend to harm, causing distress and impacting daily life. Despite its prevalence among young people, there are currently no therapies designed specifically for adolescent paranoia, making this study important to fill that treatment gap. Participants will receive TRUST, a six-session individual psychological intervention combining values-based work and mental imagery techniques. The therapy sessions include assessment and psychoeducation, identifying personal values and goals, using imagination to change negative beliefs, and reviewing progress. The study uses a single-case experimental design with baseline periods of 2 to 4 weeks before starting the weekly one-hour therapy sessions. During the study, participants complete questionnaires before, during, and after the intervention, with a follow-up one month later. Researchers will assess recruitment, retention, adherence to therapy, and acceptability of the intervention. They will also monitor changes in paranoia severity using the Revised Green et al., Paranoid Thoughts Scale R-GPTS and other measures of beliefs, imagery, values, and daily functioning. The total participation spans up to 14 weeks, including therapy and follow-up assessments.

Researchers are evaluating the acceptability and feasibility of the Kiso Mind smartphone app as a new digital intervention for people diagnosed with schizophrenia or schizoaffective disorder. This randomized controlled pilot trial compares the use of the Kiso Mind app plus treatment-as-usual TAU with TAU alone. The study aims to explore how well participants accept and can use the app, alongside measuring changes in symptoms and social functioning over 12 weeks. Participants assigned to the experimental group receive access to the Kiso Mind app for 12 weeks. The app offers psychoeducation modules and various psychotherapeutic activities based on cognitive behavioral therapy principles, along with tools like medication reminders, mood tracking, and emergency contacts. Participants in the control group continue with their usual psychiatric care, which typically involves quarterly medication appointments and limited psychotherapy. Throughout the study, participants complete self-report and clinician-rated assessments at the start and end of the 12-week period to measure symptoms, social functioning, self-efficacy, and quality of life. Data are securely stored in a pseudonymized format. A qualitative interview is also conducted with those using the app to gather feedback. The study plans to enroll 60 to 80 participants and is led by Charit University in Berlin, Germany.

This research aims to evaluate an adapted version of the Helping Ovarian Cancer Patients Cope HOPE intervention designed to address burnout among gynecologic oncology clinicians. Burnout and stress in these clinicians can lead to serious personal, professional, and societal impacts including distress, mental illness, poorer patient outcomes, increased errors, and reduced physician availability in this specialty. The adapted intervention, called HOPE-C, applies hope theory and social-cognitive theory to foster peer support and help clinicians reframe their challenging experiences. The study includes three main objectives. First, clinicians review the HOPE-C materials and provide feedback through interviews and questionnaires to help develop the intervention. Next, clinicians participate in weekly HOPE-C sessions for four weeks, each lasting about 30 to 45 minutes, focusing on changing their narrative, managing uncertainty, and finding meaning. After completing the sessions, clinicians complete questionnaires and may participate in follow-up interviews to optimize and assess the intervention. Participants will be assessed before, during, and after the intervention using questionnaires and interviews. Researchers will track feasibility measures such as enrollment rate, intervention completion, survey completion, as well as acceptability and satisfaction with the HOPE-C program. The study runs from the initial feedback phase through intervention delivery and follow-up, lasting several weeks, with assessments at baseline, during, and two weeks after completing sessions to understand the programs impact on clinician burnout.

This research aims to improve neuropsychological diagnostics by developing, calibrating, and evaluating new clinical and forensic neuropsychological tests. These tests focus on both instrumental and non-instrumental functions and are being studied in neurologically healthy individuals representing the Italian population, as well as in patients with various neurological and neuropsychiatric conditions. The goal is to modernize and expand diagnostic tools to meet clinical and forensic needs, including remote testing and assessments of testamentary capacity. Participants include people with brain disorders and neurologically healthy controls. The study involves cognitive and behavioral tests and questionnaires designed to assess various mental functions. These tests will be administered at baseline, then repeated after one month for healthy participants, and at 6, 12, and 18 months for those with neurodegenerative disorders to evaluate changes over time. Throughout the study, participants will undergo multiple assessments including tests like the Brief Assessment of Social Skills-Dementia, Picture Interpretation Test, and Telephone Interview for Cognitive Status among others. These evaluations are done at enrollment and at scheduled intervals to monitor cognitive and behavioral changes. The study will track outcomes to understand test reliability and clinical usefulness over an extended period, with participation lasting up to 18 months for some individuals.

Researchers are evaluating the combined use of auricular acupressure ear seeds and nicotine replacement therapy NRT among psychiatric inpatients aged 18 to 65 who are required to abstain from smoking due to a smoke-free hospital environment. The study aims to determine if auricular acupressure can reduce nicotine withdrawal symptoms, craving, and anxiety compared to standard care with NRT alone. Participants will be randomly assigned to receive either active or sham auricular acupressure alongside their NRT treatment. Participants will all receive standard NRT prescribed by their psychiatrists, including nicotine patches or gum at doses tailored to their nicotine dependence level. The experimental group will have Vaccaria seeds applied to five specific ear acupuncture points, while the control group will receive sham patches without seeds. Both groups will press the ear patches three times daily for four weeks, with weekly replacement of the patches to maintain hygiene and adhesion. During the study, participants will complete assessments measuring craving, nicotine withdrawal symptoms, and anxiety levels at baseline, day 14, and day 28. Heart rate variability will also be monitored to assess autonomic nervous system function. The research team will closely track adherence and any changes in symptoms throughout the 28-day intervention period to evaluate the potential benefits of adding auricular acupressure to standard nicotine replacement therapy.