Post-Traumatic Stress Disorder (PTSD)

Researchers are evaluating whether a structured training program for intensive care unit (ICU) staff can reduce health problems known as post-intensive care syndrome (PICS) in adults after they leave the hospital. PICS includes new or worsened physical, thinking, or emotional difficulties following serious illness, which can affect daily life, independence, memory, mood, and overall quality of life. This multicenter study compares patients treated before and after ICU staff training, focusing on whether the training reduces PICS three months after hospital discharge. The study also compares standard training on the ABCDEF care bundle with an expanded A-Z bundle that includes additional care elements like nutrition, sleep, infection prevention, safety, and psychological support. The study involves a cluster-randomized design where entire ICUs are assigned to receive training on either the standard ABCDEF bundle or the expanded A-Z bundle. The training program for ICU staff includes a month-long online course with educational materials, checklists, pocket guides, and visual reminders, plus face-to-face sessions to reinforce learning. After training, ICUs continue usual care while researchers track how often the trained care practices are followed during patients' ICU stays, up to 21 days or until discharge or death. Follow-up visits for patients occur at 1, 3, 6, and 12 months after hospital discharge. Participants are adults who stay in the ICU for at least 48 hours and leave the hospital alive. They will undergo tests and questionnaires on physical health, memory, mood, and quality of life during follow-up visits. Data collection includes ICU care details and patient outcomes, monitored using electronic forms with quality checks. The main outcome measured is the number of participants who develop PICS three months after discharge. Secondary outcomes include adherence to care bundles, incidence of delirium, and quality of life assessments at various timepoints. The study runs until 2028 and maintains ethical and data protection standards throughout.

Women who have experienced interpersonal violence often face a higher risk of developing post-traumatic stress disorder (PTSD). In France, female victims can request a medico-legal examination at a clinical forensic medicine unit, which also offers initial psychological assessment. However, many women do not attend follow-up appointments. This research is a prospective, multicenter, open-label, randomized controlled trial aiming to evaluate the effectiveness of a case management algorithm that uses early phone contact to improve clinical outcomes after such consultations for female victims of violence. Participants are divided into two groups. The experimental group, called VIGITRAUMA, will receive a phone call three weeks after their consultation, with a second call if needed. If contact is not made after the second call, a postcard will be sent. The control group will receive the usual follow-up care without this additional phone contact. The study is conducted by the University Hospital, Lille. Participants will be assessed through phone calls at 3, 6, and 12 months after their consultation to monitor clinical outcomes. Researchers will measure PTSD symptom severity, general psychopathology, somatic symptoms, medical costs, judicial outcomes, suicidal thoughts, and suicide attempts. The study aims to track these outcomes over a full year to understand the impact of the case management algorithm compared to standard care.

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.

Researchers are evaluating the effectiveness of two PTSD treatments, Cognitive Processing Therapy (CPT) and STAIR Narrative Therapy (SNT), among adults who identify as part of the LGBTQIA+ community. The study aims to find out which treatment better reduces PTSD symptoms, improves quality of life, and lessens depression. It also explores how stress from stigma, discrimination, and drug or alcohol use may affect treatment outcomes, and whether these treatments work differently for various groups within the LGBTQIA+ population. Participants will be randomly assigned to receive either CPT, which involves about 12 sessions focusing on changing beliefs and processing emotions related to trauma, or SNT, a longer therapy with about 16 sessions including coping skills for emotional regulation and a trauma-focused narrative component. Treatments are delivered either in person or via videoconferencing. The study compares these two therapies to understand which is more effective for LGBTQIA+ adults with PTSD. During the study, participants will complete assessments at the start and at 3, 6, and 12 months to measure changes in PTSD symptoms, depression, quality of life, and satisfaction with therapy. Researchers will also track treatment completion rates. The total participation time covers these assessments and treatment sessions, with monitoring to understand how well participants respond and adhere to the therapies.

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-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.

Post-Traumatic Stress Disorder (PTSD) affects up to 17% of post-9/11 US Service Members and is linked to long-term challenges such as family problems, unemployment, and risk of suicide. Trauma-focused therapies like Prolonged Exposure (PE) help many but are not effective for everyone, with about 40% retaining their PTSD diagnosis after treatment. This research aims to test whether adding a partner-assisted approach, called Partnered Prolonged Exposure (PPE), can improve psychosocial functioning and treatment outcomes compared to standard PE in Veterans. The study compares standard PE, which involves weekly 90-minute therapy sessions with the Veteran and therapist, to PPE, which adapts PE by incorporating strategies from Integrative Behavioral Couples Therapy. PPE includes twice-weekly 60-minute sessions, some with the Veteran and their intimate partner together and some with the Veteran alone. The partner acts as a coach and helps with trauma-related discussions, aiming to enhance treatment effects. The trial is a randomized controlled study involving 210 Veterans and their partners. Participants and their partners will undergo assessments at the start, mid-treatment, end of treatment, and at 3- and 6-month follow-ups. These evaluations include measures of psychosocial functioning, PTSD symptoms, depression, relationship functioning, caregiver burden, and distress. Researchers will also conduct interviews to understand factors influencing treatment and explore differences based on military sexual trauma history. The total study duration spans several months of treatment and follow-up to monitor outcomes and implementation strategies.

Researchers are investigating the effects of continuous theta burst stimulation (cTBS) to the intraparietal sulcus (IPS) on arousal symptoms in patients with posttraumatic stress disorder (PTSD). This mechanistic clinical trial aims to show that IPS cTBS reduces arousal, measured by startle response, better than sham cTBS, enhances extinction training effects, and improves retention of extinction learning, which is similar to exposure therapy. The study also seeks to find the optimal dose of IPS cTBS and understand its neural mechanisms through brain imaging. Participants will be randomly assigned to receive either real IPS cTBS or sham cTBS. The cTBS will be delivered using a device targeting the IPS at a set intensity. Some participants will also undergo extinction training or neutral training to evaluate combined effects. The treatment involves multiple sessions over a defined period, including intensity adjustments to find the best dose. Brain scans such as resting state fMRI will be performed to assess neural changes. During the study, participants will undergo several assessments including electromyography to measure startle response on specific days, subjective distress ratings, and brain imaging. Researchers will monitor changes in arousal and retention of extinction learning over time. This study includes detailed safety and eligibility evaluations, and participants will be followed up for several weeks to observe lasting effects. Total participation time spans multiple visits with evaluations before, during, and after treatment.

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.