Efficacy of supervised immersive virtual reality-based training for the treatment of chronic fatigue in post-COVID syndrome: study protocol for a double-blind randomized controlled trial (IFATICO Trial).

BACKGROUND: The treatment of persistent fatigue after COVID-19 infection is complex. On the one hand, it involves maintaining a sufficient level of physical and mental activity to counteract possible degenerative processes of the body and nervous system. On the other hand, physical and mental activities can also lead to worsening of symptoms. Therefore, the challenge in treating Post-COVID fatigue is to stimulate the body and central nervous system in a way that stimulates growth and improvement, but does not overtax individual physical and mental limits. Special training programs try to take these characteristics into account, but often reach their limits. A promising approach is offered by new fitness technologies based on immersive virtual realities that stimulate both body and brain while minimizing physical and psychological stress. The aim of this study is to investigate the efficacy of supervised immersive Virtual Reality (VR)-based activity training compared to conventional activity training for patients with Post-COVID-associated fatigue. METHODS: In a single centre, individually randomised, prospective, double-blind two-arm exploratory superiority trial with parallel group design, N = 100 patients with persistent fatigue after COVID-19 infection will be recruited. The intervention includes a supervised immersive neuromuscular training (12 sessions of 30 min over 6 weeks) based on a novel VR-exercise device. We will systematically compare the effects of this intervention on Post-COVID-associated fatigue with a supervised conventional activation program of comparable scope without an immersive environment. The primary outcome is the difference between groups in absolute change in the mean fatigue symptom severity measured on the Fatigue Severity Scale (FSS) from baseline to posttreatment assessment. Posttreatment assessment in both groups will be conducted by blinded outcome assessors. At three and six months afterwards, patients are sent self-report questionnaires for follow up. The main analysis will be based on the intention-to-treat principle. DISCUSSION: To the best of our knowledge, this is the first exploratory study on a supervised immersive neuromuscular training for the treatment of persistent fatigue after COVID-19 infection. TRIAL REGISTRATION: German register for clinical studies (ID: DRKS00032059) Prospectively registered on June 16th 2023. URL of trial registration.

Refocusing of Attention on Positive Events Using Monitoring-Based Feedback and Microinterventions for Patients With Chronic Musculoskeletal Pain in the PerPAIN Randomized Controlled Trial: Protocol for a Microrandomized Trial.

BACKGROUND: Chronic musculoskeletal pain (CMSP) affects between 13% and 47% of the population, with a global growth rate of 20.3% within the last 15 years, suggesting that there is a high need for effective treatments. Pain diaries have long been a common tool in nonpharmacological pain treatment for monitoring and providing feedback on patients' symptoms in daily life. More recently, positive refocusing techniques have come to be used, promoting pain-free episodes and positive outcomes rather than focusing on managing the pain. OBJECTIVE: This study aims to evaluate the feasibility (ie, acceptability, intervention adherence, and fidelity) and initial signals of efficacy of the PerPAIN app, an ecological momentary intervention for patients with CMSP. The app comprises digitalized monitoring using the experience sampling method (ESM) and feedback. In addition, the patients receive 3 microinterventions targeted at refocusing of attention on positive events. METHODS: In a microrandomized trial, we will recruit 35 patients with CMSP who will be offered the app for 12 weeks. Participants will be prompted to fill out 4 ESM monitoring questionnaires a day assessing information on their current context and the proximal outcome variables: absence of pain, positive mood, and subjective activity. Participants will be randomized daily and weekly to receive no feedback, verbal feedback, or visual feedback on proximal outcomes assessed by the ESM. In addition, the app will encourage participants to complete 3 microinterventions based on positive psychology and cognitive behavioral therapy techniques. These microinterventions are prompts to report joyful moments and everyday successes or to plan pleasant activities. After familiarizing themselves with each microintervention individually, participants will be randomized daily to receive 1 of the 3 exercises or none. We will assess whether the 2 feedback types and the 3 microinterventions increase proximal outcomes at the following time point. The microrandomized trial is part of the PerPAIN randomized controlled trial (German Clinical Trials Register DRKS00022792) investigating a personalized treatment approach to enhance treatment outcomes in CMSP. RESULTS: Approval was granted by the Ethics Committee II of the University of Heidelberg on August 4, 2020. Recruitment for the microrandomized trial began in May 2021 and is ongoing at the time of submission. By October 10, 2022, a total of 24 participants had been enrolled in the microrandomized trial. CONCLUSIONS: This trial will provide evidence on the feasibility of the PerPAIN app and the initial signals of efficacy of the different intervention components. In the next step, the intervention would need to be further refined and investigated in a definitive trial. This ecological momentary intervention presents a potential method for offering low-level accessible treatment to a wide range of people, which could have substantial implications for public health by reducing disease burden of chronic pain in the population. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43376.

Clinical Phenomenology of Fibromyalgia Syndrome in Male Patients: Same But Different.

The majority of knowledge about fibromyalgia syndrome (FMS) derives from studies of female patients. Little is known about the clinical characteristics and treatment outcomes of male patients with FMS. In this retrospective cohort study with a prospective posttreatment follow-up, we investigated whether male patients with FMS differ from female patients in terms of 1) symptom burden, 2) psychological characteristics, and 3) clinical treatment response. We identified 263 male (4%) out of 5,541 patients with FMS completing a 3-week multimodal pain-treatment program. Male patients (51.3 ± 9.1 years) were age- and time-matched (1:4) with female patients (N = 1,052, 51.3 ± 9.0 years). Data on clinical characteristics, psychological comorbidities, and treatment responses were obtained from medical records and validated questionnaires. Levels of perceived pain, psychological comorbidity, and functional capacity were similar between genders, although male patients with FMS showed a higher prevalence of alcohol abuse. Compared to female patients, male patients experienced themselves less often as overly accommodating (Cohen's d = -.42) but more often as self-sacrificing (d = .26) or intrusive (d = .23). Regarding pain coping, male patients were less likely to utilize mental distraction, rest- and relaxation techniques, or counteractive activities (d = .18-.27). Male patients showed a slightly worse overall response rate than women (69% vs 77%), although differences between individual outcome measures were small (d < .2). Although male and female patients in our cohort were similar in clinical presentation and treatment response, the gender-specific differences in interpersonal problems and pain coping suggest consideration of these aspects in the treatment of male patients with FMS. PERSPECTIVE: Knowledge about fibromyalgia mostly derives from studies of female patients. Identifying and understanding gender-specific differences in fibromyalgia is an important roadmap in the treatment of this syndrome by focusing on specific gender aspects such as differences in interpersonal problems and pain coping mechanisms.

How symptoms of simple acute infections affect the SSS-8 and SSD-12 as screening instruments for somatic symptom disorder in the primary care setting.

Objective: Somatic symptom disorder (SSD) is one of the most common reasons for consultations in primary care, in addition to simple acute infections. Questionnaire-based screening instruments to identify patients at high risk of SSD are thus of great clinical relevance. Although screening instruments are frequently used, it is currently unclear to what extent they are influenced by the concurrent presence of simple acute infections. Therefore, this study aimed to investigate how symptoms of simple acute infections affect the two established questionnaires as screening instruments for somatic symptom disorder in the primary care setting. Methods: In our cross-sectional, multicenter design, a total of 1,000 patients in primary care practices were screened using the two most established SSD screening questionnaires, the 8-item Somatic Symptom Scale (SSS-8) and the 12-item Somatic Symptom Disorder-B Criteria Scale (SSD-12), followed by clinical assessment by the primary care physician. Results: A total of 140 patients with a simple acute infection (acute infection group, AIG) and 219 patients with chronic somatic symptoms (somatic symptom group, SSG) were included. The patients in the SSG showed higher total SSS-8 and SSD-12 scores than the patients in the AIG; however, the SSS-8 was more susceptible to changes triggered by symptoms of a simple acute infection than the SSD-12. Conclusion: These results suggest that the SSD-12 is less susceptible to symptoms of a simple acute infection. Its total score and corresponding cutoff value provide a more specific and thus less susceptible screening tool for identifying SSD in primary care.

Stress biomarkers in individuals with fibromyalgia syndrome: a systematic review with meta-analysis.

ABSTRACT: Evidence suggests an involvement of hypothalamic-pituitary-adrenal (HPA) axis dysregulation in the development and maintenance of fibromyalgia syndrome (FMS). However, studies on the stress response via the HPA-axis in individuals with FMS show conflicting results. To better understand the relationship between FMS and HPA-axis dysregulation, we (1) systematically summarized the current level of evidence on HPA biomarkers in individuals with FMS compared with individuals without and (2) evaluated whether FMS is associated with a specific pattern of HPA dysregulation. The main outcome measures were cortisol, adrenocorticotropic hormone (ACTH), corticotropin-releasing hormone (CRH), epinephrine, and norepinephrine. A systematic search of MEDLINE, EMBASE, and PsychMed yielded 47 studies eligible for meta-analysis, including 1465 individuals with FMS and 1192 FMS-free controls. No main effect of FMS was found on altered levels of blood cortisol, ACTH, CRH, and epinephrine. Compared with controls, salivary and urinary cortisol levels were decreased in individuals with FMS, whereas blood levels of norepinephrine were increased. However, heterogeneity of data was high with significant evidence for publication bias. Overall, the data are compatible with association of FMS with adrenocortical hypofunction in the presence of increased sympathetic tone. However, the data are partially contradictory, so it must be assumed that the data are highly dependent on the respective study designs, patient samples, and analytical methods and do not necessarily demonstrate an abnormal HPA-axis function in FMS.

[Psychosocial factors in pain and pain management : A statement]. / Psychosoziale Faktoren bei Schmerz und Schmerzbehandlung : Eine Positionsbestimmung.

Although psychosocial factors have a profound impact on the experience of pain and pain recovery, the transfer to clinical application has so far been insufficient. With this article, a task force of the special interest group "Psychosocial Aspects of Pain" of the German Pain Society (Deutsche Schmerzgesellschaft e. V.) would like to draw attention to the considerable discrepancy between existing scientific evidence on the importance of psychosocial factors in the development of chronic pain disorders and the translation of these findings into the care of pain patients. Our objective is a stronger integration of psychological and psychosomatic expertise in pain treatment and research, as well as the improvement of structural and institutional conditions, to achieve an increased consideration of psychosocial aspects. In this way, modern, integrative and complex pain concepts can reach the patient. Based on these fundamental findings on the importance of psychosocial factors in pain and pain treatment, implications for the transfer to clinic and further research will be shown.

[Psychosomatics in Pain Therapy - Challenges of Chronic Pain]. / Psychosomatik in der Schmerztherapie ­ Herausforderungen chronischer Schmerzen.

Although there is growing awareness among physicians regarding chronic pain, the patient with chronic pain is often considered a complex, if not "difficult" patient in practice. Patients with chronic pain are thus at increased risk of being hastily dismissed and sent on their way. At the same time, therapeutic options are often limited and therapeutic successes not satisfying.

Preferred and perceived participation roles of oncological patients in medical decision-making: Results of a survey among users of the German Cancer Information Service.

BACKGROUND: Cancer patients are facing a variety of treatment and other disease-related decisions. This study aims to provide insights into preferred and perceived participation roles in decision-making among patients with diverse tumors using the German Cancer Information Service (CIS). METHODS: Patients' decision-making preferences and experiences were assessed as a part of a cross-sectional survey among CIS users. An adapted version of the Control Preferences Scale (CPS) was used to assess preferred and perceived participation roles in eight different areas of medical decision-making (e.g., choice of medication, termination of treatment). Logistic regression analyses were applied to explore preference matching and to analyze associations between participation roles and sociodemographic variables. Moreover, we examined preferences and perceptions of participation roles across different decision situations. RESULTS: In the final sample (N = 1566, 64.9% female, mean age = 61.6), almost half of the patients (47.1%) preferred to take a collaborative role in decisions on treatment methods, whereas 36.3% preferred an active role and 15.9% a passive role. Collaborative role preferences frequently (40.7%) coincided with experiencing a passive role and predicted a reduced chance of a match between preferences and experiences (OR = 0.57, p = .001). A higher level of education was associated with a lower chance of preferring and perceiving a passive role (OR = 0.85, p < .01). Compared with men, women had increased odds of preferring (OR = 1.45, p < .05) and of actually taking (OR = 2.04, p < .001) a passive role in medical encounters. Preferred participation roles regarding treatment methods were highly correlated with preferences in all other decision areas (r > .50, p < .001) except decisions about family involvement. CONCLUSIONS: The study reveals well-known deficits in the fulfilment of patients' collaborative role preferences across different areas of medical decision-making in a sample of CIS users characterized by high information-seeking behavior. Participation roles were not only influenced by the patients' level of education but also by their gender. The gender effect may be more pronounced than previous studies suggest. These effects should be considered in the development of interventions to promote shared decision-making. Additionally, study results indicate that preferences for participation in decisions about treatment methods, as assessed by the CPS, can be generalized to other areas of medical decision-making.

Moving towards patient-centered care and shared decision-making in Germany.

The main focus of this paper is to describe the development and current state of policy, research and implementation of patient-centered care (PCC) and shared decision-making (SDM) in Germany. What is the current state in health policy? Since 2013, the Law on Patients' Rights has standardized all rights and responsibilities regarding medical care for patients in Germany. This comprises the right to informed decisions, comprehensive and comprehensible information, and decisions based on a clinician-patient partnership. In addition, reports and action plans such as the German Ethics Council's report on patient well-being, the National Health Literacy Action Plan, or the National Cancer Plan emphasize and foster PCC and SDM on a policy level. There are a number of public organizations in Germany that support PCC and SDM. How are patients and the public involved in health policy and research? Publishers and funding agencies increasingly demand patient and public involvement. Numerous initiatives and organizations are involved in publicizing ways to engage patients and the public. Also, an increasing number of public and research institutions have established patient advisory boards. How is PCC and SDM taught? Great progress has been made in introducing SDM into the curricula of medical schools and other health care providers' (HCPs) schools (e.g., nursing, physical therapy). What is the German research agenda? The German government and other public institutions have constantly funded research programs in which PCC and SDM are important topics. This yielded several large-scale funding initiatives and helped to develop SDM training programs for HCPs in different fields of health care and information materials. Recently, two implementation studies on SDM have been conducted. What is the current uptake of PCC and SDM in routine care, and what implementation efforts are underway? Compared to the last country report from 2017, PCC and SDM efforts in policy, research and education have been intensified. However, many steps are still needed to reliably implement SDM in routine care in Germany. Specifically, the further development and uptake of decision tools and countrywide SDM trainings for HCPs require further efforts. Nevertheless, an increasing number of decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care. Also, recent implementation efforts are promising. For example, reimbursement by health insurance companies of hospital-wide SDM implementation is being piloted. A necessary next step is to nationally coordinate the gathering and provision of the many PCC and SDM resources available.

Higher Levels of Psychological Burden and Alterations in Personality Functioning in Crohn's Disease and Ulcerative Colitis.

Aims: Is there evidence for increased psychological distress and alterations in personality functioning in patients with Crohn's disease (CD) and ulcerative colitis (UC) compared to healthy controls (HCs)? Background: In patients with CD and UC, perceived stress is closely associated with changes in disease activity. The stress response is influenced by psychological burden and personality functioning, but only little is known about these factors in inflammatory bowel diseases (IBD). Study: A total of 62 patients with an endoscopic ensured CD/UC without remission (n = 31 per group) and 31 HC were included. Patients with an active CD/UC and HC were individually matched (n = 93, 31 per group) for age, sex, education, and disease activity. Depression and anxiety were assessed to evaluate the effect of psychological burden (Patient Health Questionnaire-9/PHQ-9, Generalized Anxiety Disorder-7/GAD-7). Personality functioning was measured by validated questionnaires for psychodynamic structural characteristics, mentalization, and attachment (Operationalized Psychodynamic Diagnosis-Structure Questionnaire/OPD-SQ, Mentalization Questionnaire/MZQ, and Experiences in Close Relationships scale/ECR-RD 12). Results: Levels of depression and anxiety were higher in CD/UC patients than in HC with large effect sizes. Comparing personality functioning in CD/UC with HC, psychodynamic structural characteristics differed between CD/UC and HC with medium effect sizes, with structural differences occurring primarily in the domain of self-perception and regulation. Only minor differences were found regarding mentalization and attachment. CD and UC differed only with small effect sizes. Conclusion: Our data show that compared to HC, patients with CD/UC are characterized by a higher level of psychological burden and structural alterations in the domain of self.

Different Dimensions of Affective Processing in Patients With Irritable Bowel Syndrome: A Multi-Center Cross-Sectional Study.

Objective: Deficits in affective processing are associated with impairments in both mental and physical health. The role of affective processing in patients with functional somatic complaints such as irritable bowel syndrome (IBS) remains unclear. Most studies have focused on the capacity for emotional awareness and expression, but neglect other dimensions of affective processing. Therefore, this study aimed to systematically analyze differences in six different dimensions of affective processing between patients with IBS and healthy controls (HCs). Additionally, we exploratively investigated the impact of IBS symptom severity, psychological distress, and attachment styles on affective processing in IBS. Methods: A controlled cross-sectional multi-center study was conducted. Overall, 127 patients with IBS were compared with 127 matched HCs using multivariate analysis of variances. Affective processing was operationalized in line with the affect cascade model on six specific dimensions: emotional experience, emotional awareness, affect tolerance, affect differentiation, affect regulation, and emotional communication. They were measured using two subscales of the Mentalizing Questionnaire (MZQ) and four subscales of the Operationalized Psychodynamic Diagnosis-Structure Questionnaire (OPD-SQ). Linear regression analysis was used to investigate the influence of IBS symptom severity (IBS-Severity Scoring System, IBS-SSS), depression (Patient Health Questionnaire, PHQ-9), anxiety (General Anxiety Disorder, GAD-7), and anxious and avoidant attachment styles (Experiences in Close Relationships Scale, ECR-RD12) on the different dimensions of affective processing in IBS. Results: Patients with IBS compared to HCs showed deficits in all six dimensions of affective processing. Deficits were largest for affect tolerance (d = 0.849) and lowest for emotional experience (d = 0.222) and emotional awareness (d = 0.420). Moderate effect sizes were found for affect differentiation (d = 0.773), emotional communication (d = 0.665), and affect regulation (d = 0.552). Moreover, explorative analyses indicated that affective processing in patients with IBS was significantly influenced by levels of anxiety and insecure attachment. Conclusion: The results indicate a specific pattern of affective processing abilities in patients with IBS. The deficits in affective processing are more prominent in the area of understanding and tolerating difficult affective states than experiencing affective states. This opens interesting perspectives for the development of specific psychotherapeutic interventions. Clinical Trial Registration: DRKS00011685.

Development and validation of a web-based patient decision aid for immunotherapy for patients with metastatic melanoma: study protocol for a multicenter randomized trial.

BACKGROUND: Patients with metastatic melanoma and their physicians are confronted with a complex decision regarding first-line therapy. Risks and benefits vary considerably between various treatment options. With this in mind, we aim to develop and evaluate a patient decision aid (PtDA) to inform patients about the risks and benefits of treatment options, namely, immunotherapy as monotherapy, immunotherapy as combination therapy, and treatment with BRAF/MEK inhibitors. We aim to test whether the use of this PtDA before medical consultation will increase patients' knowledge of treatment options and thus promote shared decision-making (SDM) and patient decision satisfaction. METHODS: In total, 128 patients with metastatic melanoma from two German cancer centers will be randomized to the intervention group (IG), receiving access to the PtDA before medical consultation, or the control group (CG), receiving treatment as usual (TAU), i.e., medical consultation alone. There will be three major assessment points (before intervention, T0; after intervention, T1; and 3 months after intervention, T2). The main outcome is the patient's knowledge of their treatment options, measured by a self-developed, piloted multiple-choice test at T1. Secondary outcome measures will include the extent of SDM during medical consultation, assessed by Observer OPTION 5, and patient decision satisfaction, assessed by the Satisfaction with Decision Scale (SwD), at T1 and T2. DISCUSSION: This trial will assess the effectiveness of a developed PtDA to enhance patient knowledge of treatment options for metastatic melanoma, SDM, and patient decision satisfaction. If the efficacy can be proven, the PtDA will be implemented nationwide in Germany to close a relevant gap in the education and care of patients with metastatic melanoma. TRIAL REGISTRATION: ClinicalTrials.gov NCT04240717 . Registered on 27 January 2020.

The Validity of Somatic Symptom Disorder in Patients With Gastrointestinal Complaints.

BACKGROUND AND GOAL: The current diagnostic concept of somatic symptom disorder (SSD) aims to capture psychological burden due to bodily complaints independent of the medical cause. The aim of this study was to compare patients with chronic gastrointestinal (GI) complaints with SSD (SSD+) and without SSD (SSD-) along sociodemographic, clinical, and psychological characteristics. STUDY: This cross-sectional study included 199 patients (n=92 SSD+ and n=107 SSD-) with distressing and chronic abdominal/lower GI complaints (≥6 mo) recruited from several primary, secondary, and tertiary medical care units. SSD+ patients were separated from SSD- patients by psychobehavioral positive criteria. Psychological distress (somatization, depression, anxiety, and illness anxiety) and risk factors (adverse childhood experiences, insecure attachment, mentalizing capacity, and levels of personality functioning) were measured. Nonparametric group comparisons were performed to analyze the differences of sociodemographic, clinical, and psychological characteristics between SSD+ and SSD- patients. RESULTS: About half of the SSD+ patients had a functional GI disorder and a third had an inflammatory bowel disease. SSD+ patients reported higher GI pain severity, higher health-related and work-related impairment, and higher psychological distress, especially illness anxiety, as well as higher mentalizing and personality functioning deficits. CONCLUSIONS: Overall, psychobehavioral positive criteria of SSD seem to be a valid identifier of patients exhibiting a high psychological burden, independent of the medical explanation of the GI complaints. There is a substantial overlap of SSD and general mental burden, but also evidence for a specific disease entity.

[Psychosocial factors in the prevention of pain]. / Psychosoziale Faktoren in der Prävention von Schmerz.

The question of pain prevention is becoming increasingly important, both in society and in science. According to the International Society for the Study of Pain, general areas for which pain prevention measures can be recommended have been defined. These approaches are mostly limited to unspecific recommendations with the aim of improving general health behaviour. Common to all of them is that they essentially address psychosocial and psychobehavioral aspects. In contrast to genetic factors or other non-modifiable environmental factors, psychosocial and psychobehavioral aspects are potentially modifiable variables, making them possible starting points for prevention programs. Furthermore, recent studies provide important knowledge about psychological and social risk factors of pain chronification and thus offer new approaches for future pain prevention strategies. At the same time, the efficacy and successful implementation of such programs is so complex that valid statements on effectiveness and benefit can only be made through care-related evaluation. This review addresses psychological and social factors in the prevention of pain. A selective literature search was carried out to this end. Based on selected studies, psychological and social predictors of pain development are presented and their potential for future pain prevention programs discussed. The article concludes with a discussion of possible implications.

Relationship between adverse childhood experiences and illness anxiety in irritable bowel syndrome - The impact of gender.

OBJECTIVE: Irritable bowel syndrome (IBS) is a functional disorder with a complex biopsychosocial etiopathogenesis. Various psychosocial factors like adverse childhood experiences (ACE) and illness anxiety appear to be relevant, but underlying mechanisms are still not fully understood. Furthermore, there are indicators of gender specific effects of ACE on IBS. Therefore, this study analyzed group differences between IBS patients and healthy controls (HCs) according to ACE and illness anxiety, and the relationship between ACE and illness anxiety by taking gender differences into consideration. METHODS: A cross-sectional multi-center study was conducted comparing IBS patients with HCs. Illness anxiety was recorded using the Whiteley-Index-7, childhood adversities via the 10-item Adverse-Childhood-Experiences-score, anxiety by the Generalized Anxiety Disorder seven-item questionnaire and depressive symptoms using the nine-item depression module of the patient-health-questionnaire. Group differences between IBS patients and HCs were analyzed and correlation analyses were performed. RESULTS: Overall, 127 gender and education matched participants per group were included. Compared to HCs, IBS patients were characterized by higher prevalences for adverse childhood experiences (63.8% vs. 48.0%, p = .02, OR = 1.33) and increased levels of illness anxiety (p < .001, η2 = 0.595). Taking into account gender specific effects, there was a significant correlation between adverse childhood experiences and illness anxiety in female IBS patients, but not in male (r = 0.242, p = .03 vs. r = 0.162, p = .29). However, after controlling for depression and anxiety, this correlation disappeared. CONCLUSION: Our findings suggest a possible gender-specific association of ACE with illness anxiety in female IBS patients that might be linked to increased levels of depression and anxiety. TRIAL REGISTRATION: DRKS00011685.

Stressful Life Events Moderate the Relationship Between Changes in Symptom Severity and Health-related Quality of Life in Patients With Irritable Bowel Syndrome.

OBJECTIVES: The relationship between changes in symptom severity and health-related quality of life (HRQOL), which may be impacted by stressful life events, in irritable bowel syndrome (IBS), is unclear. Therefore, we investigated the relationship between changes in symptom severity and HRQOL and examined the moderating role of stressful life events in patients with IBS. METHODS: This study is part of a cohort follow-up study on psychological factors in patients with IBS in tertiary care, and it included 158 patients. In addition to symptom severity and HRQOL, stressful life events were assessed by the Social Readjustment Rating Scale (SRRS). The relationship between symptom severity and HRQOL and the moderating role of stressful life events (in the 12 mo before the follow-up assessment) were analyzed. RESULTS: The majority of participants had moderate levels of stressful life events (41.8%), followed by those who had mild levels (39.2%) and severe levels (19.0%) of stressful life events. Symptom severity could predict HRQOL, and the relationship between symptom severity and HRQOL was affected by the level of stressful life events. Compared with mild levels of stressful life events, a severe level of stressful life events significantly affected the relationship between changes in symptom severity and HRQOL (Z=-3.048, P<0.01). A similar result was found when comparing moderate and severe levels of stressful life events (Z=-1.810, P<0.10). CONCLUSIONS: The study demonstrated that symptom severity predicted HRQOL during the progression of IBS and that stressful life events moderated the impact of symptom severity on HRQOL. The more stressful life events an IBS patient experiences, the less predictable the relationship is between changes in symptom severity and HRQOL.

High Rates of Non-Response Across Treatment Attempts in Chronic Irritable Bowel Syndrome: Results From a Follow-Up Study in Tertiary Care.

Objective: Despite a wealth of treatment options for irritable bowel syndrome (IBS), data on the subjective experience of treatments in ongoing clinical practice are sparse. This follow-up study assessed the individual usage of treatment modalities by IBS patients over time and investigated the patients' subjective experience of therapeutic impact. Methods: The study was conducted at the Specialty Clinic for Functional Gastrointestinal Disorders of the Heidelberg University Hospital. All patients who fulfilled the Rome III criteria for IBS and treated in our outpatient clinic between January 2012 and December 2016 were invited to the assessment. The primary outcome variables were individual usage of treatment modalities and the Patient Global Impression of Change (PGIC) with treatments. Results: Three hundred and sixty-six patients fulfilled the Rome III criteria for IBS and thus were eligible for this study. Two hundred and seven patients dropped out from the study. The study could include 159 patients (43.7 ± 17.1 years; 71.1% female). The mean time since the first visit to the clinic was 2.8 ± 1.3 years (median 3.0 years). The mean time of symptom duration was 14.1 ± 11.1 years (median 10 years). The average number of treatment attempts was 12, ranging from 2 to 39). With respect to the subjective experience of therapeutic impact, there were no significant differences in the PGIC scores among different treatments (p = 0.183). The rates of non-response rates (minimally improved, no change, or minimally worse) ranged from 63.0% to 83.9%. The PGIC score was correlated negatively with the mean number of treatment attempts (r = -0.316, p < 0.01). The mean number of treatment attempts was correlated negatively with quality of life (r = -0.262, p < 0.01). Conclusion: A multidisciplinary treatment approach of IBS is characterized by high rates of non-response and a high number of frustrating treatment attempts. The connection between the various treatment attempts and the frustrating subjective experience of therapeutic impact puts a substantial burden on IBS patients.

Does symptom activity explain psychological differences in patients with irritable bowel syndrome and inflammatory bowel disease? Results from a multi-center cross-sectional study.

OBJECTIVE: Irritable bowel syndrome (IBS) and inflammatory bowel diseases (IBD) have similar symptoms and are affected by psychological factors via gut-brain-interactions. However, previous studies on IBS and IBD showed inconsistent results regarding psychological factors, potentially because they failed to consider the impact of symptom activity. The aim of this study was 1) to compare psychological distress and psychological risk factors among patients with IBS, IBD and healthy controls (HC), and 2) to assess the impact of symptom activity. METHODS: A controlled cross-sectional study was conducted. Patients with IBS and IBD were recruited in several primary, secondary, and tertiary medical care units between 02 and 12/2017 in Germany. Overall, 381 matched participants (127/group, 63% female) were included. For the second analyses, patients with IBD were distinguished in patients with active (n = 93) and non-active (n = 34) symptoms. Psychological distress (somatization, depression, anxiety, and illness anxiety) and risk factors (adverse childhood experiences, attachment style, and mentalizing capacity) were measured. RESULTS: Patients with IBS showed higher psychological distress and more psychological risk factors than patients with IBD and HC. However, patients with IBD and active symptoms showed similar psychological distress than patients with IBS, except for lower illness anxiety (p < .001, η2 = 0.069). CONCLUSION: With the exception of higher illness anxiety in IBS patients, differences in psychological factors between patients with IBS and IBD were more strongly associated with symptom activity than with the underlying diagnosis. Therefore, this study challenges previous concepts of distinguishing functional and organic gastrointestinal diseases, but highlights the role of symptom activity and illness anxiety. TRIAL REGISTRATION: DRKS00011685.