Clinical Research Directory

Reducing Fear of Cancer Recurrence in Danish Colorectal Cancer Survivors

Cognitive therapy has been shown to reduce fear of cancer recurrence (FCR), mainly in breast cancer survivors. The accessibility of cognitive behavioural interventions could be further improved by Internet delivery, but self-guided interventions have shown limited efficacy. The aim of this study is to test the efficacy of a therapist guided internet-delivered intervention (TG-iConquerFear) vs. augmented treatment as usual (aTAU) in Danish colorectal cancer survivors.

Central Processing of Odour Stimuli in Patients With Functional Somatic Disorder, MCS or Post Covid Compared to Healthy Controls

Background: Functional somatic disorders (FSD) are frequent in all medical settings and characterized by persistent physical symptoms that cannot be explained by other somatic or psychiatric conditions. In recent decades, a number of different types of functional somatic disorders have been defined, but so far there is no clear explanation for the pathophysiology. The high prevalence of olfactory problems in some patients with FSD suggests that olfactory symptoms are a potential diagnostic biomarker, especially in patients with multiple chemical sensitivity (MCS) and/ or post-covid. The olfactory system is a unique sense with direct pathways to the limbic system, which is associated with emotion and mood. The focus on the olfactory system has revealed a significant association of this sense with numerous diseases. Hypotheses: * Patients with MCS and FSD have normal olfactory tests (normosmic subjects according to TDI score using "sniffing test") but differ in habituation test compared to healthy controls. * MCS, post-covid and FSD patients have different odour perception processing in the brain as a "fingerprint" of functional somatic disorder compared to healthy controls. Research plan: The aim of this parts of the study is to identify specific MRI and paraclinical measures for MCS, post covid and BDS. In the first phase, 5 patients with MCS and 5 healthy controls will have a full clinical test of the olfactory system at the Flavour Institute, AU. In addition, they will be scanned (for "fingerprinting") where the investigators expect to find changes in olfactory connectivity similar to those seen in depression. This phase of the study will lead to a conclusion on the exact MR parameters to be used in the main study. In the second phase of the study, 10 patients with MCS, 10 with post-covid, 10 with FSD, and 10 healthy controls will be evaluated using a test battery of questionnaires and paraclinical tests. Perspectives: Previous imaging studies have focused on pain stimulation paradigms, rest-state fMRI, and DTI, but the olfactory system may be the "missing link" in identifiying a quantitative candidate in terms of whole-brain computational modeling and could potentially be used as a "fingerprint" in diagnosis and treatment monitoring.

DISTRESS Trial Functional Disorders - the DISTRESS Trial

A Diagnostic Clinic for Functional Somatic Disorders (FSD) has been set up at the outpatient diagnostic center at Regionshospitalet Silkeborg. The objective of the clinic is to support General Practitioners (GPs) by offering early stage diagnostic evaluation of whether a patient has an FSD or the symptoms were caused by another physical illness or mental disorder. As a novelty in this project, Internal Medicine consultants examine the patients for FSD, after having received training in diagnosing FSD by FSD experts. By performing diagnostic evaluation for physical diseases and FSD simultaneously, the investigators believe that the new clinic shall be able to accelerate the establishment of a final diagnosis for these patients who would otherwise likely undergo a protracted diagnostic course involving sequential evaluations at various specialty clinics. The DISTRESS trial is a pragmatic randomized clinical trial which aims to evaluate the Diagnostic Clinic for FSD in terms of clinical cost-effectiveness outcomes.