Clinical trials

The study aims to evaluate the impact of integrating a clinical pharmacist into Flexible Assertive Community (FACT) teams on health-related quality of life and pharmacotherapy for individuals with severe mental illness and substance use disorders. This is a pragmatic effectiveness study using a stepped wedge cluster randomized trial design. Four FACT teams from FACT Innlandet will serve as clusters, transitioning from standard care (control) to intervention in a randomized sequence. The intervention involves integrating a clinical pharmacist into the interdisciplinary FACT teams. Participants will be adults (over 18 years old), receiving treatment from participating FACT teams, diagnosed with severe mental illness or substance use disorder and prescribed at least one psychotropic medication. Exclusion criteria include inability to provide informed consent, planned discharge within the first three months of period 1, or inability to communicate in Norwegian or English. The control group receives standard care provided by FACT teams. The intervention group will have a clinical pharmacist integrated into the FACT team performing medication reconciliation, comprehensive medication reviews, patient counselling, and interdisciplinary discussions to resolve medication-related problems. A sample size of 160 patients is estimated based on an effect size of 0.25, 80% power and alpha=0.05. The primary endpoint is change in patient-reported health related quality of life, measured using the EuroQoL-5 dimensions-5 levels (EQ-5D-5L) and Visual Analog Scale, EQ-VAS scores from baseline to the end of the intervention.

In this randomized controlled trial, we will evaluate if bipolar enucleation of the prostate (BEEP) is associated with better urinary voiding outcome than transurethral resection (TURP) in men with enlarged prostate referred to surgery. In addition we will investigate the association between symptom relief and the amount of removed tissue and if patients experience differ between the two methods. Finally, we will assess cost-effectiveness of BEEP compared to TURP. The main outcome for comparison of the two surgical methods is International Prostate Symptom Score (IPSS) assessed at 12-month follow-up. The primary outcome to assess patient experience is measured with the questionnaire Nordic Patients Experience Questionnaire (NORPEQ). Cost-effectiveness will be measured with incremental cost-effectiveness ratio (ICER).

ROPVR, a multi-centre, pragmatic randomized controlled trial (RCT) aims to evaluate a VR-technology which has been developed within an exploratory study and a development study, which facilitates social functioning among persons with a substance use and mental health disorder. Investigators will test a VR-program versus treatment as usual among patients enrolled into a long-term addiction-treatment facility. The RCT aims to evaluate the effectiveness of VR training compared to treatment as usual in improving resilience, quality of life, practical and social functioning and social participation (from baseline to 6 months), and to evaluate the cost-effectiveness of VR training versus treatment as usual.

The main goal of this clinical trial is to examine screen delivery as an alternative for offering cognitive therapy to youth with social anxiety. It will examine its effectiveness compared to office delivery, but also its acceptability and sustainability, and identify factors important for the outcome of this approach. The main questions it aims to answer are: Does screen delivery show comparable effectiveness to office delivery? Is screen delivery well accepted by youth and therapists? Does screen delivery show economic and climate sustainability? Do credibility and therapeutic alliance predict therapy outcome? In the study researchers will compare screen delivery to office delivery of cognitive therapy for social anxiety disorders in 200 youth aged 14-18 years. After an initial screening in schools, eligible youth are assessed with a diagnostic interview. Those meeting inclusion criteria will be offered either screen or office therapy. This is decided by random selection (a draw). Participants will: Complete an initial short screening questionnaire. Respond to a diagnostic interview online. Meet their therapist first time in person. Attend 14 weekly 90-minutes therapy session. Complete weekly questionnaires during the therapy. Answer interview and questionnaires after the therapy, and also 6 months, 2 years and 4 years later. Parents are also interviewed and informed of the study.

A multicenter randomized controlled trial comparing midline laparotomy closures using the small-bite suture technique alone to those using the small-bite suture technique with an additional onlay prophylactic polypropylene mesh. The primary endpoint is the incidence of incisional hernias in both groups after one year.

Existing treatment for individuals with psychosis primarily targets positive symptoms but has only modest effects on cognition and negative symptoms. Cognitive strategy training shows promising effects in reducing negative symptoms and increasing activity initiation in individuals with schizophrenia. This project aims to investigate the effect of the Perceive, Recall, Plan and Perform (PRPP) intervention in promoting effective use of cognitive strategies for adults with schizophrenia in performing their daily activities. Twenty-seven individuals with schizophrenia will be recruited from Sykehuset Innlandet (Innlandet Hospital Trust) and assessed using PRPP prior to an eight-session PRPP intervention. Re-assessment will be conducted after the intervention, as well as at 3 and 6 months, to evaluate the long-term effects of the intervention. A single-case design will be used to investigate the intervention's effects. The primary outcome measure will be the PRPP assessment, and the secondary outcome measure will be the Goal Attainment Scale (GAS). Generalization measures will be used to evaluate whether there are relevant changes beyond the primary and secondary goals.

Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. Poor status is also seen in affluent countries such as in Norway. Vitamin B12 is crucial for normal cell division and differentiation and necessary for the development and myelination of the central nervous system. Deficiency is also associated with impaired fetal and infant growth. In the proposed study we will measure the effect of daily oral vitamin B12 supplementation infants on neurodevelopment. We also aim to measure the impact of B12 supplementation on several other outcomes. Study design: Individually randomized double-blind placebo-controlled trial breastfed infants who will be assigned to a screening group (in which measurements will be obtained immediately) or a control group (in which serum will be stored and measurements done after one year). Pregnant women will be informed about the study during their first antenatal visit at the clinic and that we will re-approach them on their 6-week visit to their public health nurse. Infants who are deficient will be treated with peroral or intramuscular injections with 400 µg cyano-cobalamin. Infants in the control group will not be offered any intervention their blood sample will be stored for one year and then analyzed for the same nutrients as the intervention group. Outcomes: Primary: (i) neurodevelopment in children measured at 12 months of age (ii) growth in children measured by attained weight and length at 12 months. Secondary: (i) neurodevelopment and cognitive functioning in children later in life

Observational study on laparoscopic and robotic extraperitoneal mesh repair of parastomal hernia, employing TAR.