Fredrikstad

Researchers are evaluating a preventive intervention called Condensed Internet-delivered Prolonged Exposure (CIPE) for people who have symptoms of post-traumatic stress disorder (PTSD) about one month after experiencing a traumatic event. The study aims to test the effectiveness and cost-effectiveness of CIPE in Norwegian municipal psychosocial crisis services, comparing it to usual treatment. This research addresses the lack of evidence-based preventive options available for trauma victims in Norway and explores how CIPE may reduce PTSD symptoms, depression, insomnia, prolonged grief, and the need for specialized mental health care. CIPE is a therapist-supported program delivered online through four modules. It includes education about normal trauma reactions, exposure techniques to confront reminders of trauma both in real life and imagination, and a breathing exercise. Participants receive CIPE alongside treatment as usual (TAU), which varies but generally involves psychological first aid, psychoeducation, social support activation, and practical help. The study compares outcomes between those receiving CIPE plus TAU and those receiving only TAU. Participants are involved for at least 6 weeks after starting treatment, with follow-ups at 6 and 12 months post-trauma. Researchers assess symptoms using the PTSD Checklist for DSM-5 (PCL-5) and measure depression, insomnia, prolonged grief, treatment satisfaction, and referrals to specialized care. The study also evaluates quality of life and cost-effectiveness of adding CIPE to usual care. Participants must complete questionnaires and provide informed consent, with language requirements for English or Norwegian speakers aged 16 to 99 years.

Mental health problems affect about one in five working-age adults in OECD countries, posing a significant challenge for public health and work productivity. Common mental disorders (CMD), such as major depression and anxiety, are leading causes of work absenteeism, accounting for 30% of all sick leave in Norway in 2024. This research investigates a digital, transdiagnostic work-focused cognitive behavioral therapy (CBT) program designed to help patients with CMD who are on sick leave or work assessment allowance, focusing on improving return to work and user experience with the program. The treatment being studied is a digital CBT program that addresses core mechanisms maintaining depression and anxiety, such as avoidance and suppression of unwanted thoughts, and promotes cognitive flexibility under stress. The program consists of seven modules with psychoeducational materials and therapist-tailored tasks. Trained eTherapists provide guidance mainly through asynchronous messaging, with phone or face-to-face contact as needed. After 12 weeks of treatment, participants have a concluding session to decide next steps, and then retain access to the program without therapist support for six additional months. Participants will be assessed at multiple time points including baseline, 6 weeks, 12 weeks, 6 months, and 12 months for outcomes such as degree of sick leave and return to work self-efficacy. Data collection includes self-reported questionnaires on symptoms and functioning, system data on program use, and qualitative interviews with a subset of participants. Safety monitoring includes weekly suicide risk assessments. The study plans to enroll 390 participants over 18 months from specialized outpatient mental health care in Norway.

Researchers are investigating how Helicobacter pylori infection is managed across Europe by collecting detailed information on diagnosis, treatment, and outcomes in routine clinical practice. H. pylori is a common infection linked to chronic gastritis, peptic ulcers, and gastric cancer, making its effective management important for reducing serious health problems and healthcare costs. This study aims to create a comprehensive database over one year that reflects real-world treatment approaches and adherence to clinical guidelines. The study is a non-intervention prospective registry involving up to ten gastroenterologists from 30 European countries. Each participating doctor will record information from their usual outpatient consultations of adult patients infected with H. pylori. Data collected includes patient demographics, symptoms, diagnostic tests, treatment regimens, drug dosages, treatment duration, adherence, side effects, and eradication success. This observational approach allows evaluation of current practices without altering patient care. Participants will receive routine clinical assessments as part of their care, with researchers gathering anonymized data through electronic case report forms. The study will analyze treatment effectiveness, safety, guideline adherence, and accessibility to diagnostic methods and medications. Outcomes measured include prescribed treatments over one year and eradication rates confirmed by tests. This registry supports ongoing improvements in managing H. pylori infection by providing a large, representative sample of European clinical practice.

Researchers are investigating whether an online education program for clinical staff can improve the implementation of Hospital-at-Home (HaH) services in hospitals across Denmark, Norway, and Sweden. This study is part of the Nordic Digital Health & Education (NorDigHE) project, which aims to address challenges in scaling HaH models that deliver hospital-level care at home, particularly in response to healthcare pressures like aging populations and staff shortages. The trial uses a randomized controlled design to compare hospitals receiving the NorDigHE education to those continuing usual care. The intervention includes an online, asynchronous HaH education combining e-learning, simulations, reflection exercises, and practical training. This education is integrated with tailored implementation tools based on the WHO Fast-track Implementation Model, such as workshops, meetings, guides, and a specialist hotline to support incorporating HaH into daily hospital routines. Hospitals are randomized to either receive this education or continue with their usual treatment practices, with the control group offered access to the education after the study. Participants, including clinical staff and hospital management, will complete baseline, 3-month, and 6-month surveys measuring HaH activity, knowledge, and motivation. The intervention group also completes a 12-month follow-up. Additionally, patients, staff, and management are invited to share their experiences through interviews. The main outcome measured is the level of HaH implementation at the organizational level, with secondary measures including hospital and home patient days, readmission rates, and mortality. Data collection spans up to 12 months for the intervention group, ensuring comprehensive monitoring of HaH adoption and impact.

Researchers are investigating the effectiveness of approved anti-cancer drugs used outside their usual indications for patients with advanced cancer who have specific molecular changes identified through genetic testing. This nationwide, phase 2 study in Norway uses a combined umbrella and basket design to explore drug and biomarker combinations across different cancer types. Biological samples will be collected at diagnosis, during treatment, and if the disease progresses to better understand factors affecting drug response and resistance. Patients eligible for this study have advanced cancer that has been previously treated with standard therapies and have acceptable organ function and performance status. Treatment is guided by molecular testing results and recommendations from a national tumor board. Patients receive drugs matched to their tumor's molecular profile, with treatment eligibility confirmed before starting. New patient groups may be opened if no suitable cohort exists. The drug Atezolizumab is among those evaluated, administered according to protocol-specific criteria. Participants will be closely monitored for tumor response, survival, treatment duration, and side effects including serious toxicities. They will undergo molecular testing including whole genome sequencing from tumor biopsies and liquid biopsies. Data on treatment outcomes and molecular markers will be collected and reported to national cancer registries. Patients not enrolled in treatment cohorts will be followed for 16 weeks to track disease progression and survival, with long-term follow-up planned through national health databases.

Acute chest pain is a common medical emergency faced in primary emergency care settings. Diagnosing acute myocardial infarction (MI) before hospital admission is challenging due to the lack of highly sensitive diagnostic tools. While clinical signs, risk assessments, and normal ECGs can rule out MI, chest pain often leads to many hospital referrals even though it is frequently not caused by heart problems. This research will evaluate a new point-of-care (POC) whole-blood assay to improve diagnosis and management of patients with acute chest pain in emergency primary care in Norway. The study will assess the use of the QuidelOrtho TriageTrue high-sensitivity cardiac troponin I (hs-cTnI) whole-blood assay at six emergency primary care clinics. This POC test allows rapid troponin measurement outside hospital laboratories, potentially improving triage and reducing unnecessary hospital referrals. The study plans to enroll 2,500 patients over 1.5 years and will compare the new testing strategy to standard care. Researchers will also examine how this strategy affects healthcare usage and patient outcomes. Participants will be assessed for the total number of acute myocardial infarctions within 30 days and complete questionnaires on quality of life at the start and after 90 days. The study will monitor the prevalence of ongoing chest pain and its impact on quality of life, psychological stress, and anxiety. Overall, the trial aims to improve emergency primary care for chest pain patients by providing better management, reducing hospital referrals, and promoting sustainable healthcare use.

Researchers are evaluating whether treating minimal residual disease (MRD) relapse after initial treatment can extend progression-free survival and overall survival in patients with multiple myeloma. This study focuses on patients who achieve MRD negativity following first-line treatment, including autologous stem cell transplantation, as part of a phase II/III trial conducted according to Norwegian standard care. The trial aims to create a uniform group of MRD-negative patients who will then enter a randomized phase to compare treatment timings. In the first phase, 391 newly diagnosed multiple myeloma patients eligible for high-dose therapy and stem cell support receive standard first-line treatment with bortezomib, lenalidomide, and dexamethasone in four pre-transplant induction cycles and four post-transplant consolidation cycles. After induction, patients undergo a single or tandem autologous stem cell transplant based on response and toxicity. Those achieving MRD-negative complete response will be randomized into two groups: one starting second-line treatment at MRD relapse and the other starting at clinical progressive disease. Both groups receive carfilzomib, dexamethasone, and daratumumab in 28-day cycles until disease progression or unacceptable side effects. Participants will have regular monitoring including MRD assessments every four months in the early treatment arm and standard follow-up in the other. Additional MRD evaluations occur at specific timepoints during second-line therapy. Researchers will measure progression-free survival over 10 years and overall survival over 11 years, as well as MRD negativity status shortly after consolidation treatment. The study duration and close clinical monitoring aim to evaluate the timing of treatment initiation and its impact on patient outcomes.

Researchers are evaluating whether non-surgical treatment is no worse than surgical treatment for adults aged 18 to 65 years who have displaced extraarticular lateral clavicle fractures. The study focuses on functional outcomes, using patient-reported measures to assess recovery. The main goal is to compare treatments by measuring arm, shoulder, and hand disability one year after treatment. Participants will be randomly assigned to receive either non-surgical treatment with a simple sling and physiotherapy following a standardized program, or surgical treatment involving plate and screws, such as lateral clavicle plates or hook plates, with or without coracoclavicular fixation. This pragmatic, multicenter trial lasts 12 months and aims to determine if non-surgical care is not inferior to surgery. During the study, participants will be monitored through various assessments, with the primary outcome being the Disabilities of the Arm, Shoulder and Hand (DASH) score at one year. Follow-up will include patient-reported outcomes to evaluate functional recovery and the ability to complete care. Researchers will also track safety and monitor adherence to treatment protocols throughout the study period.

Researchers are investigating the factors that trigger eating disorders in athletes, focusing on why some athletes develop these conditions while others in the same sports environment do not. The study builds on previous research from 30 years ago that identified early specialization, high training volume, and traumatic experiences as possible causes. This research also seeks to understand athletes' views on how body dissatisfaction and eating disorders might be better prevented and addressed in sports, considering changes in sports culture and social media's role. Participants will share their personal experiences through individual interviews guided by a set interview template. The study involves two groups: athletes with a current or past eating disorder and athletes from the same clubs who have not had an eating disorder. By comparing these groups, researchers aim to explore self-perceived triggers and prevention strategies from the athletes' perspectives. During the study, data will be collected from August to December 2024, focusing on the timing of eating disorder symptoms, causes leading to eating disorders, knowledge about these disorders, and preventive measures. The study will involve collecting and analyzing the athletes' experiences to inform the development of supportive guidelines, rule changes, and educational efforts to help prevent eating disorders in sports.