Active clinical trials for "Medically Unexplained Symptoms"

Background: The prevalence of severe health anxiety is reported to be 1-2% in Western communities. This functional disorder is difficult for medical doctors to treat, the course of the disorder is often chronic, and that is costly for the social and health care systems as well as for the patients. A Cochrane metaanalysis from 2009 finds evidence for effectiveness of individual cognitive behavior therapy (CBT) for patients with hypochondriasis. But no randomised controlled trials (RCT) of the effectiveness of classical CBT delivered only in groups for patients with severe health anxiety (hypochondriasis/illness anxiety disorder) has yet been conducted. Aims: 1) to examine the effectiveness of group-CBT for patients with severe health anxiety compared to a wait-list group receiving usual care, 2) to perform a categorical and dimensional assessment of personality, 3) to examine predictors of outcome especially comorbid personality disorders, 4) to examine the relation between personality, illness perception and treatment outcome, 5) to compare the cost-effectiveness of these two treatments, 6) at a 2 years follow up to examine the course and long-term effectiveness of group-CBT for patients with severe health anxiety and some also followed by psychological treatment for comorbid personality disorders. Main hypothesis: Patients with severe HA who have received group CBT will at 6-month follow-up compared to a wait-list group receiving usual care show a significantly reduction in health anxiety. Methods: 84 patients referred from medical doctors during 2014-15 to the Clinic of Liaison Psychiatry in Koege, Region Zealand, Denmark, will be included and block randomised per 14 patients to either weekly group-CBT with 7 patients and 2 therapists for 3 hours a week in 12 weeks or wait-list with usual care for 9 months. Inclusion: Severe health anxiety (dominant mental disorder), score on WI-7>21,4, age 18-65 years, Danish speaking, informed consent. Exclusion: Another severe treatment demanding mental disorder, risk of suicide or psychosis, a serious somatic disease, pregnancy, dependency of drugs, alcohol or medication. Diagnostic assessment: The patients are included using research criteria for severe health anxiety (for ICD-11) and semi-structured interviews developed for DSM-IV, SCAN (general psychopathology) and SCID-II (personality disorders). Criteria for hypochondriasis from ICD-10 and illness anxiety disorder/somatic symptom disorder from DSM-5 are used for subcategorising. Dimensions and traits of personality are assessed by the questionnaire PID-5 included in DSM-5, section III. Outcome measures: The primary outcome measure is the questionnaire for health anxiety, Whiteley Index 7 (WI-7), with a cut-off for remission on 21,4 or a blinded diagnostic assessment of no severe health anxiety present 6 months after end of treatment. The secondary outcome measures are questionnaires for health anxiety (HAI), general psychopathology (SCL-90-R), level of personality disorders (PID-5), level of functioning (SF-36), quality of life (WHO-5, EQ-5D), Illness perception (IPQ), alcohol consumption (CAGE) and register data for number of sick days and use of social and health care and a blinded global assessment of functioning (F-GAF). Time frame: Data wil be analysed, and results wil be disseminated from 2016.

The main purpose of the study is to conduct an initial feasibility evaluation of the new Internet-based EAET treatment manual. We will include 50 patients with somatic symptom disorder to take part of the treatment for nine weeks through the Internet. A within-subject design will be used. Self-report measures of symptom level and mechanisms of change will be conducted weekly. Feedback on content, process and potential caveats will be collected using surveys and written evaluations from the participants at post-treatment. Linear mixed models will be used to investigate trajectories of change in symptoms and processes.

The goal of this study is to test the feasibility and acceptability of providing an experiential assessment interview that targets emotional and stressful experiences in primary care. In this randomized, controlled trial, the investigators will compare an interview condition to a wait-list control condition. The investigators hypothesize that helping individuals first identify the links between their stress and symptoms will likely increase their awareness and endorsement of the link between stress and physical symptoms, including a willingness to engage in stress management techniques. It is also expected that helping raise an individual's awareness about their symptoms, followed by an experience and expression of unexpressed emotions is likely to influence their physical symptoms and psychological status.

In this study, a new psychosocial training for social relationships for adults will be evaluated. In a 6-module course, with four 3-day modules and two 5-day modules in the timeframe of one year, participants learn ways to strengthen their personal resources to establish effective social relationships and to develop skills as a social being. In between the module courses, the participants take 5 single sessions with an instructed trainer and document 10 conversations/social situations where they successfully apply the acquired personal and social skills. For my study, I will recruit a total of 200 persons. Approx. one hundred participants for the intervention group and 100 individuals for the control group. During the course of the training, the participants are taught social and personal skills that should result in a lower perceived stress level in daily life, improved health behaviour, a decreased presence of common somatic symptoms, a higher satisfaction with their lives, improved quality of their social relationships and a higher wellbeing. Data from study participants having accomplished additional training programs with the same training provider will be used to evaluate the influence on the results compared to participants without the extra addition for this study. The training participants will be assessed together with the controls. All study participants will be evaluated with standardized online questionnaires.

The purpose of this study is to evaluate the effectiveness of a new cognitive behavioural therapy (CBT) group for individuals with a somatic symptom disorder (i.e., Somatic Symptom and Related Disorders from the DSM-5). Patients with somatic symptom and related disorders are underserved by the medical system. Further, there is currently a paucity of research aimed at evaluating treatments for patients with somatic symptom disorders. The limited existing research literature supports CBT as an efficacious treatment in this population, but a standardized means of modifying CBT for somatic symptom disorders has not been developed, and it is unclear if group CBT is effective. In this study, the investigators will evaluate the effectives of a new six session CBT group designed specifically to address commonly-reported difficulties among individuals with somatic symptom disorders, such as somatic symptoms, psychological distress, and related cognitive interference. This study will allow us to validate a new intervention for somatic symptom disorders, and will help to fill the current void of evidence-supported evaluation and treatment protocols to better serve patients with somatic symptom disorders.

The purpose of this study is to evaluate whether 3 years after the end of therapy cognitive-behavioral therapy complemented with strategies from emotion regulation training leads to better improvement in somatic symptoms and comorbid problems in patients with chronic multiple somatoform symptoms than cognitive behavioral therapy alone.

The purpose of this study is to evaluate whether a forced isolation context (such provided by the ongoing Covid-19 pandemic restrictive measures) could reduce the burden of somatic symptoms among a group of patients with Somatic Symptom Disorder (SSD). Secondary objective is to assess if a reduction in terms of depression tendency and anxiety occurs in this specific population and which are the effect of such a context among a group of adolescents without SSD. We want to compare these results with data obtained at the end of the pandemic.

Research has shown that patients with functional somatic symptoms continue to worry about having a serious disease despite medical reassurance from their doctors. This study aims to investigate whether cognitive immunization is a mechanism that underlies the sustained concern about having serious disease. To this end, the use of cognitive immunization strategies will be experimentally modulated after receipt of medical test results.

The aim of this study is to evaluate the clinical effectiveness of internet-based cognitive therapy for severe health anxiety within regular psychiatric care. A longitudinal cohort study will be conducted investigating 400 patients who have received ICBT for severe health anxiety between 2018-2020 in an outpatient psychiatric clinic providing Internet-based treatment. The primary outcome measure will be the Short Health Anxiety Inventory, SHAI, and a within-group design with repeated measures will be used for primary analysis. It is hypothesized that ICBT will be associated with a significant reduction in health anxiety as measured with SHAI, both after treatment and at six-month follow-up.

The objective of this study is to explore the role of neuroticism, perceived stress, and adverse life events, respectively, in the development and perpetuation of functional somatic disorders.