Clinical trials

This clinical study investigates the effectiveness of two psychological treatment formats for young people aged 16-25 with symptoms of depression, anxiety, stress, or interpersonal difficulties. The study compares group-based Acceptance and Commitment Therapy (ACT) with treatment as usual (TAU), most frequent that would be individual psychotherapy, both of which are established treatment approaches. The study uses a randomized controlled design (RCT), in which participants are randomly assigned to one of the two treatment conditions. This allows for a systematic comparison of treatment outcomes between ACT delivered in a group format and standard individual therapy. The ACT group intervention consists of a structured program in which participants meet regularly over a defined treatment period. The treatment focuses on processes such as psychological flexibility, acceptance of internal experiences, and engagement in actions aligned with personal values. The individual therapy condition consists of one-to-one sessions with a clinician, following standard therapeutic practice. Treatment content and duration are tailored to the participant's clinical presentation and therapeutic needs. Outcome measures include standardized assessments of mental health symptoms, functioning, and psychological processes. These assessments are conducted at baseline, during the treatment period, at post-treatment, and at follow-up time points. Data collected from these measures will be used to evaluate changes over time and differences between the two treatment conditions. The primary aim of the study is to determine whether group-based ACT is as effective as, or more effective than, individual psychotherapy for young people receiving mental health services. The results are expected to contribute to improved knowledge about treatment options for this age group and inform future clinical practice.

Generalized anxiety disorder (GAD) is a serious and long-lasting condition that can greatly reduce quality of life, work functioning, and use of health services. Metacognitive therapy (MCT) is an effective treatment for GAD, but it is not yet known whether individual MCT or group-based MCT provides the best results for patients. This randomized controlled trial will compare two formats of MCT: individual treatment and group-based treatment (g-MCT). A total of 64 adults with GAD (32 in each treatment arm) will participate after providing informed consent. Participants will complete questionnaires, undergo clinical assessments, and allow the study to collect relevant health information from official registries. The main aim of the study is to determine whether group-based MCT is non-inferior to individual MCT. A non-inferiority design tests whether the group format is not meaningfully less effective than the individual format. If group MCT is shown to have similar effects on anxiety symptoms and functioning, it could offer an efficient and resource-saving alternative in routine clinical care. This will be the first study to systematically compare these two treatment formats in a real-world clinical setting. If group MCT proves to be as effective as individual therapy, it may help increase access to evidence-based treatment for people with GAD, reduce strain on mental health services, and support the development of more accessible and cost-effective care.

This PhD project investigates the effect of "the good pain consultation" and early integration of biopsychosocial pain education with current standard management of endometriosis. Our goal is to facilitate self-management of pain and improve health-related quality of life (HRQOL) using limited resources. Our research question is: Does a good pain consultation improve pain self-efficacy and HRQOL, compared to usual care at 3 months and 1 year.? Researchers will compare a good pain consultation to a control group that will receive usual care. Participants will: Attend a consultation and biopsychososial pain education plus usual care or usual care alone. They will answer questions in an internet-based questionnaires three times point during the study.

This study evaluates whether a procedure using a new wireless heart sensor patch is equal to or better than the standard hospital procedures and equipment at detecting an irregular heartbeat called Atrial Fibrillation (AF) after an ischemic stroke. Atrial fibrillation is a major cause of stroke, but it can be difficult to catch because it often comes and goes. The study will include approximately 450 adults who have had a stroke or a transient "mini-stroke" (TIA) within the last two weeks. Participants will be assigned by chance (randomized) to one of two groups: * Group 1 (Intervention): Participants wear the "ECG247 Smart Heart Sensor." This is a small patch that sticks to the chest and connects to a smartphone. It is worn continuously for up to 14 days, even after leaving the hospital. * Group 2 (Standard Care): Participants receive the standard hospital check-up. This typically involves using a "Holter monitor" (a device with wires and electrodes) for a period of about 24 to 48 hours some time after leaving the hospital. The main goal is to see if the procedure using the patch is equal to the standard procedure in detecting atrial fibrillation in participants. The study will also measure how quickly doctors can start the correct medication and how easy the patients find the devices to use.

From observational studies, it is know that the risk of developing colorectal cancer after polyp removal is lower if the patients adheres to surveillance recommendations. However, colonoscopy is burdensome for patients and colonoscopy availability is limited in many parts of the world. In addition, more than half of surveillance colonoscopies are without any findings. The trial investigates whether surveillance using fecal testing for blod is as good as colonoscopy after removal of colorectal polyps.

The goal of this action research project is to develop and implement nature- and activity-based group interventions across health care, school and leisure settings in Southern Norway. The interventions are tailored to support the mental health, self-efficacy and daily life functioning of children and youth in the Agder region, with a particular focus on youngsters who struggle due to neurodivergence, such as Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD) or Tourette's syndrome. The main questions we aim to answer are: 1. To what extent does nature- and activity-based outdoor education contribute to improvements in children's quality of life? 2. To what extent does nature- and activity-based interventions in a health care setting improve children's self-efficacy, self-esteem and quality of life? 3. Is there a difference in physiological reactions between nature-based provision of education or therapy and traditional indoor provision of education or therapy? Participants will take part in a 12-week school-based or health care intervention.

By longitudinal, prospective research in children and adolescents with Fetal Alcohol Spectrum Disorders (FASD) and their parents to explore the beneficial effects of participating in a standardized intervention program in order to treat and reduce the consequences of early brain damage. By using elements from international programs based on psychoeducation and parent training, the investigators aim to help parents to better understand and respond to the neurodevelopmental disabilities of their children, and thereby improving behavioral problems and self-regulation deficits.

Infectious keratitis is a significant cause of partial vision loss and blindness and places a large burden on eye care professionals. One of the main challenges for the ophthalmologist when presented with a case of suspected microbial keratitis is the determination of the subtype of keratitis. It must be determined whether the origin of the infection is bacterial, viral, fungal, or parasitic, in order to prescribe a correct, effective treatment aimed at the causative pathogen. In daily practice this can be challenging, and general treatments with antibiotics are prescribed. Some cases then experiences deterioration, resulting in more patients visits and further rounds of invasive treatments and progressive vision deterioration. This project is designed to break this cycle of nonspecific diagnosis, suboptimal treatment, and progressive worsening of vision with increased interventions. New, advanced diagnostics will be brought into the clinic to provide additional information which, if our hypothesis is correct, will result in more rapid and accurate diagnosis of the keratitis subtype. This will translate into earlier administration of a more targeted treatment, avoiding the repeated round of non-targeted treatment and progressive worsening of the patient's vision. This can directly reduce to number of clinic visits and specialist time required for treatment and follow-up of keratitis, knowledge of how the eye responds to various microbes by initiating a specific cascade of molecular inflammatory signals and changes in protein expression in the tear film. Using in vivo confocal microscopy (IVCM) we will document the cellular status of the cornea and identify microbes infecting the cornea in real-time. Secondly, tear samples will be obtained from patients with keratitis to evaluate and quantify the molecular cytokine signatures associated with specific microbial species, confirmed by microbiological culture. We will for the first time develop cytokine profiles for the various types of infection, identifying diagnostic cytokines which in the longer term can lead to development of rapid point-of-care biomarker diagnostics. The project aims are translated into the following hypotheses: H1: In vivo confocal microscopy imaging features detect microbial keratitis consistent with clinical assessment and outcome at a greater frequency than microbiological culture results. H2: Cytokine profiles (or a subset of molecules) in the eye are specific for viral, bacterial, fungal, or amoebic keratitis; and H3: A combination of in vivo confocal microscopy and molecular profiling of the tear film can yield a specific keratitis diagnosis closely matching the clinical progression and outcome of keratitis.

The regional health authorities of South-East Norway has commissioned Sørlandet Hospital (SSHF), Norway to establish mechanical thrombectomy in large-vessel occlusion stroke. SSHF is a limited volume stroke center, and introduction of thrombectomy may impose quality challenges. Therefore the implementation will be guided by a simulation based quality assurance program. In this study, we will monitor timelines, technical and clinical outcomes, including adverse events.

The goal of this clinical trial is to assess effect of Intravenous immunoglobulins (antibodies) as compared to Placebo, on pain intensity in patients from 18-65 years with painful sensory neuropathy without a known cause. Effect of the treatment will be recorded by the patient in a digital diary.