Clinical Research Directory

My Symptoms Young - a New Internet-based Programme for Young People With Persistent Physical Symptoms in Primary Care: Exploration of Effect and Health Literacy Characteristics Among Users

The research programme is an ambitious effort aiming to improve overall functioning and quality of life for young people with bodily distress. Bodily distress is a condition characterized by persistent physical symptoms (PPS), such as headache, nausea or abdominal pain, not explained by a well-defined disease. Over time, PPS can develop into a functional disorder, with detrimental impact on the young person's everyday life and opportunities. Thus, early intervention is crucial, but at present, access to specialized treatment of PPS to young people in primary care is very limited. The investigators have developed the internet-based self-help programme My Symptoms Young as a new digital solution for early intervention of PPS. The intervention was developed using a high degree of user involvement (young people with PPS) and are now ready to be tested. The goal of this clinical trial is to learn and preliminary test the possible effects of the internet-based self-help intervention program My Symptoms Young in young people aged 15-25 who experience PPS (physical symptoms presenting for \>3 months). The main question the investigators aim to answer is: * What are the potential effects of My Symptoms Young In addition, the investigators aim to investigate if participation in the program can reduce overall symptom intensity and interference with daily activity in young people's lives. Finally, the investigators aim to examine if individual levels of health literacy (HL) and eHealth literacy (eHL) will modify the potential effects. * The primary outcomes will be symptom intensity and symptom interference with daily activities * The primary hypothesis will be: Symptom intensity and interference with daily activities will improve after the treatment with My Symptoms Young. The effect will be modified by levels of HL and aspects of eHL. The investigators will include a total of 62 participants. The are no comparison group. Participants will be recruited from a health care professional in primary care (either general practitioner or practising pediatrician; from now on referred to as HCP). The HCP will determine whether referral to the My Symptoms Young programme is relevant. To guide this evaluation, the HCP will use pre-defined inclusion and exclusion criteria for participation. When a young person has been referred to the project group, a research assistent from the investigator group will contact the young person to provide more detailed information on the research project and the programme. If written consent is obtained, the young person will receive access to the programme. Throughout the intervention, the referring HCP is fully responsible for the health care of the young person. Referral and participation will be documented in the participants' primary care medical journal. If participants experience physical or psychological challenges during the project, they are advised to contact the referring HCP, i.e. the responsible healthcare provider. The programme is accessed through a website, using either tablet, mobile or computer. It consists of seven modules, a closing module on relapse prevention, and a module targeting close relatives plus four tools: don't break the chain, goal setting staircase, symptom registration and notebook for reflections. The seven modules target symptom understanding, physical energy, resources and strains, thoughts, feelings, values, and self-care. Participants will gradually gain access to the modules. The programme encourages young persons to work with various exercises throughout the different modules but with freedom to choose what to work with. Besides text and exercises, the programme also includes explanatory animations, audio files on case stories, audio files on brief meditations and videos on physical exercises. At first login (baseline), the participant will need to complete a set of questionnaires to access the programme. When completed the participant receives access to the programme. The researcher will follow up with participants by phone after one week if they have not logged into the programme and after three weeks if they have logged in but remained inactive. Participants can decide individually how long they wish to use the programme, but they are encouraged and recommended to engage actively at least twice a week for a minimum of 30 minutes. Participants will have access to the program for a total of 8 weeks. They will fill in questionnaires at three time points: Baseline (first login to the programme), End of Treatment (8 weeks after baseline) and 3 months after End of Treatment.

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.

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.