Validation of the Persistent Somatic Symptom Stigma scale for Healthcare Professionals (PSSS-HCP).

OBJECTIVE: Persistent somatic symptoms (PSS) describe recurrent or continuously occurring symptoms such as fatigue, dizziness, or pain that have persisted for at least several months. These include single symptoms such as chronic pain, combinations of symptoms, or functional disorders such as fibromyalgia or irritable bowel syndrome. While many studies have explored stigmatisation by healthcare professionals towards people with PSS, there is a lack of validated measurement instruments. We recently developed a stigma scale, the Persistent Somatic Symptom Stigma scale for Healthcare Professionals (PSSS-HCP). The aim of this study is to evaluate the measurement properties (validity and reliability) and factor structure of the PSSS-HCP. STUDY DESIGN AND SETTING: The PSSS-HCP was tested with 121 healthcare professionals across the United Kingdom to evaluate its measurement properties. Analysis of the factor structure was conducted using principal component analysis. We calculated Cronbach's alpha to determine the internal consistency of each (sub)scale. Test re-test reliability was conducted with a sub-sample of participants with a two-week interval. We evaluated convergent validity by testing the association between the PSSS-HCP and the Medical Condition Regard Scale (MCRS) and the influence of social desirability using the short form of the Marlowe Crowne Social Desirability Scale (MCSDS). RESULTS: The PSSS-HCP showed sufficient internal consistency (Cronbach's alpha = 0.84) and sufficient test-retest reliability, intraclass correlation = 0.97 (95% CI 0.94 to 0.99, p<0.001). Convergent validity was sufficient between the PSSS-HCP and the MCRS, and no relationship was found between the PSSS-HCP and the MCSDS. A three factor structure was identified (othering, uneasiness in interaction, non-disclosure) which accounted for 60.5% of the variance using 13 of the 19 tested items. CONCLUSION: The PSSS-HCP can be used to measure PSS stigmatisation by healthcare professionals. The PSSS-HCP has demonstrated sufficient internal consistency, test-retest reliability, convergent validity and minimal influence of social desirability bias. The PSSS-HCP has demonstrated potential to measure important aspects of stigma and provide a foundation for stigma reduction intervention evaluation.

Which patients are at risk of developing symptom diagnoses that persist for more than a year in primary care? Development and external validation of a prediction model.

OBJECTIVES: To train, test and externally validate a prediction model that supports General Practitioners (GPs) in early identification of patients at risk of developing symptom diagnoses that persist for more than a year. METHODS: We retrospectively collected and selected all patients having episodes of symptom diagnoses during the period 2008 and 2021 from the Family Medicine Network (FaMe-Net) database. From this group, we identified symptom diagnoses that last for less than a year and symptom diagnoses that persist for more than a year. Multivariable logistic regression analysis using a backward selection was used to assess which factors were most predictive for developing symptom diagnoses that persist for more than a year. Performance of the model was assessed using calibration and discrimination (AUC) measures. External validation was tested using data between 2018 and 2022 from AHON-registry, a primary care electronic health records data registry including 73 general practices from the north and east regions of the Netherlands and about 460,795 patients. RESULTS: From the included 47,870 patients with a symptom diagnosis in the FaMe-Net registry, 12,481 (26.1%) had a symptom diagnosis that persisted for more than a year. Older age (≥ 75 years: OR = 1.30, 95% CI [1.19, 1.42]), having more previous symptom diagnoses (≥ 3: 1.11, [1.05, 1.17]) and more contacts with the GP over the last 2 years (≥ 10 contacts: 5.32, [4.80, 5.89]) were predictive of symptom diagnoses that persist for more than a year with a marginally acceptable discrimination (AUC 0.70, 95% CI [0.69-0.70]). The external validation showed poor performance with an AUC of 0.64 ([0.63-0.64]). CONCLUSION: A clinical prediction model based on age, number of previous symptom diagnoses and contacts might help the GP to early identify patients developing symptom diagnoses that persist for more than a year. However, the performance of the original model is limited. Hence, the model is not yet ready for a large-scale implementation.

Healthcare professionals' views on factors influencing persistent somatic symptoms - ARISE-HCP online survey across countries.

OBJECTIVE: The Health Care Online Survey Europe-Healthcare Professionals (ARISE-HCP) cross-sectionally investigated healthcare professionals' (HCPs) views on healthcare factors influencing the symptom course of persistent somatic symptoms (PSS) across four European countries. METHODS: An online survey was developed for HCPs experienced in PSS care in Germany, Italy, Poland, and the Netherlands. The study employed a mixed-methods approach. Quantitatively, it assessed HCPs' perspectives on training, tools, and consultation times. Qualitatively, it explored their perceptions of healthcare-related factors influencing the PSS symptom course and systemic barriers encountered in treatment and diagnosis. RESULTS: Overall, 258 HCPs participated: 152 from the Netherlands, 46 from Germany, 30 from Italy, and 30 from Poland (67% female, mean age = 47.68 ± 11.64 years). HCPs' views on PSS training, tool adequacy, and consultation time sufficiency differed significantly. Regarding symptom persistence and deterioration, HCPs from Italy and Poland highlighted access-related issues, whereas German and Dutch HCPs focused on care implementation. Across all countries, interdisciplinary collaboration was mentioned as important for symptom improvement. A more holistic approach was advocated, emphasizing the need for comprehensive PSS-focused training and the integration of these practices in care delivery, service coordination, and patient engagement. CONCLUSION: Healthcare factors associated with the course of PSS and systemic treatment and diagnosis barriers varied across different countries, highlighting the importance of considering country-specific factors in managing PSS. Taking tailored measures to enhance multidisciplinary collaboration and HCP education is essential for improving patient outcomes, and sharing knowledge about effective healthcare practices across countries can improve patient care. Future research should focus on identifying systemic barriers to optimal care and developing country-specific interventions.

Measuring persistent somatic symptom related stigmatisation: Development of the Persistent Somatic Symptom Stigma scale for Healthcare Professionals (PSSS-HCP).

OBJECTIVE: Persistent somatic symptoms (PSS) describe recurrent or continuously occurring symptoms such as fatigue, dizziness, or pain that have persisted for at least several months. These include single symptoms such as chronic pain, combinations of symptoms, or functional disorders such as fibromyalgia or irritable bowel syndrome. While stigmatisation by healthcare professionals is regularly reported, there are limited measurement instruments demonstrating content validity. This study develops a new instrument to measure stigmatisation by healthcare professionals, the Persistent Somatic Symptom Stigma scale for Healthcare Professionals (PSSS-HCP). METHODS: Development was an iterative process consisting of research team review, item generation and cognitive interviewing. We generated a longlist of 60 items from previous reviews and qualitative research. We conducted 18 cognitive interviews with healthcare professionals in the United Kingdom (UK). We analysed the relevance, comprehensibility and comprehensiveness of items, including the potential for social desirability bias. RESULTS: After research team consensus and initial feedback, we retained 40 items for cognitive interviewing. After our first round of interviews (n = 11), we removed 20 items, added three items and amended five items. After our second round of interviews (n = 7), we removed four items and amended three items. No major problems with relevance, comprehensibility, comprehensiveness or social desirability were found in remaining items. CONCLUSIONS: The provisional version of the PSSS-HCP contains 19 items across three domains (stereotypes, prejudice, discrimination), demonstrating sufficient content validity. Our next step will be to perform a validation study to finalise item selection and explore the structure of the PSSS-HCP.

Somatic symptom distress is not related to cardioceptive accuracy.

OBJECTIVE: (Cardiac) interoception was long considered a key mechanism behind symptom perception in persistent somatic symptoms (PSS). In this study, we aimed to extend earlier findings to clarify this potential interoceptive mechanisms of PSS. METHODS: A cross-sectional sample of 251 participants (23.1% with self-reported functional somatic syndrome) completed a laboratory study with two cardioceptive accuracy tasks (Schandry task and a new cardiac signal detection task) and multiple questionnaires. Somatic symptom distress and associated constructs were assessed with the PHQ-15, as well as with a novel multidimensional questionnaire measure (HiTOP-SF1) derived from the somatoform spectrum of the Hierarchical Taxonomy of Psychopathology (HiTOP). Correlations (frequentist and Bayesian) and structural equation modelling (SEM) helped further investigate the interplay between these variables. RESULTS: There were no significant correlations between measures of interoception and somatic symptom distress. Self-report and behavioral cardioceptive accuracy measures did not correlate significantly. No significant covariances emerged between diagnostic tools and cardioceptive accuracy; Bayesian analyses supported the lack of association between interoception and symptom perception. CONCLUSIONS: Cardiac interoception (specifically cardioceptive accuracy) unlikely represents a key mechanism in PSS etiology. We recommend investigating other factors in PSS.

Strategies to improve implementation of collaborative care for functional disorders and persistent somatic symptoms: A qualitative study using a Research World Café design.

INTRODUCTION: Persistent somatic symptoms and functional disorders (PSS/FD) are often complex conditions requiring care from multiple disciplines. One way of bringing the different disciplines together is through collaborative care. Little is known about the implementation barriers faced and relevant strategies to tackle the barriers in this field. Therefore, using expert knowledge, we aim to develop realistic strategies for dealing with implementation barriers of collaborative care in PSS/FD. METHODS: The Research World Café method is a single-session, expert-based method with multiple focus-groups forming and reforming to answer a set of inter-related questions, under the guidance of moderators. Using this method, participants involved in PSS/FD care across different areas of healthcare in the Netherlands developed several realistic strategies for dealing with ten implementation barriers for collaborative care in PSS/FD that were previously identified in a Delphi study. Strategies were grouped into strategy clusters using a card-sorting task. RESULTS: Thirty-three participants took part, representing ten different disciplines, most commonly physiotherapists, psychologists, and physicians. In total, 54 strategies, identified in response to the ten barriers, were grouped into eight strategy clusters. The strategy clusters were professional education, communication, care coordination, care pathways, joint consults, funding, patient involvement, and prevention. CONCLUSION: We identified a number of useful strategies for dealing with implementation barriers for collaborative care in PSS/FD. Many strategies provided ways to deal with multiple barriers at once. The effects of applying these strategies in collaborative care in PSS/FD will need testing through implementation studies, as well as in other areas needing multidisciplinary care.

"And how did that make you feel?" - Repeated symptom queries enhance symptom reports elicited by negative affect.

OBJECTIVE: Negative affect, alexithymia, and other predisposing traits (such as health anxiety) can influence an individual's symptom perception. In this study, we used the affective picture paradigm (APP, Bogaerts et al., 2010) to induce symptoms using affective picture stimuli. We aimed to cross-sectionally test the effect of high vs low-frequency symptom queries and analyze the time course of the APP, including interactions with health anxiety and somatic symptom distress. METHODS: Participants (N = 124) completed a modified APP and filled out various questionnaires. In the APP, participants were randomized to either a highly-frequent-query condition (18 symptom checklists) or a less-frequent-query condition (6 checklists). Data were analyzed using ANOVAs, cross-lagged panel models, moderation models, and multilevel models. RESULTS: Both groups had comparable symptom baseline values, but people in the highly frequent as opposed to less frequent condition reported significantly higher symptom levels once the experiment started (F (1,120) = 14.319, p < .001, η2=.107). Symptom levels stayed stable over the course of the experiment and were best predicted by symptom levels at earlier timepoints in the experiment (ß = 0.43 and ß = 0.68, both p < .001). Health anxiety levels significantly predicted symptom levels (F(1,121) = 10.054, p = .002, η2=.077) and moderated the relation between condition and symptom levels (F(2,121) = 16.253, p < .001, η2=.212). CONCLUSION: In terms of the predictive processing model (e.g.,[1]), repeated symptom queries following negative affective cues may activate prior beliefs about symptoms, resulting in elevated levels of symptom reports in interaction with health anxiety.

Quality indicators for collaborative care networks in persistent somatic symptoms and functional disorders: a modified delphi study.

BACKGROUND: Care for persistent somatic symptoms and functional disorders (PSS/FD) is often fragmented. Collaborative care networks (CCNs) may improve care quality for PSS/FD. Effectiveness likely depends on their functioning, but we lack a straightforward quality evaluation system. We therefore aimed to develop quality indicators to evaluate CCNs for PSS/FD. METHOD: Using an online three-round modified Delphi process, an expert panel provided, selected and ranked quality indicators for CCNs in PSS/FD. Recruited experts were diverse healthcare professionals with relevant experience in PSS/FD care in the Netherlands. RESULTS: The expert panel consisted of 86 professionals representing 15 disciplines, most commonly physiotherapists, psychologists and medical specialists. 58% had more than 10 years experience in PSS/FD care. Round one resulted in 994 quotations, which resulted in 46 unique quality indicators. These were prioritised in round two and ranked in round three by the panel, resulting in a final top ten. The top three indicators were: "shared vision of care for PSS/FD", "pathways tailored to the individual patient", and "sufficiently-experienced caregivers for PSS/FD". CONCLUSIONS: The identified quality indicators to evaluate CCNs in the field of PSS/FD can be implemented in clinical practice and may be useful in improving services and when assessing effectiveness.

Respiratory dysfunction in persistent somatic symptoms: A systematic review of observational studies.

OBJECTIVE: This systematic review aims to analyze the existing literature investigating respiratory functioning in people with Persistent Somatic Symptoms (PSS) compared to healthy controls, to identify patterns of respiratory disturbances by symptom or syndrome, and describe any respiratory outcomes consistent across diagnoses. METHODS: A systematic review following PRISMA guidelines was conducted. A comprehensive search was carried out across five databases (PubMed (NCBI), PsycArticles (Ovid), Web of Science (Core Collection), Embase, and Scopus) using two customised search strings for persistent somatic symptoms and objective respiratory parameters. Title/abstract screening and data extraction were carried out independently by two reviewers. The modified Newcastle-Ottawa Scale was used for quality assessment of the studies. Studies investigating baseline respiratory functioning in adult patients with PSS compared to healthy controls, using at least one objective respiratory were included. RESULTS: 18 studies met the inclusion criteria for the review, with a pooled sample size of n = 3245. Chronic pain conditions were found to be the most prevalent subset of diagnoses of interest, comprising six of the studies. 10 studies included measures of lung capacity, flow and/or volume, nine studies reported measures of ventilation, and four studies investigated respiratory muscle functioning. 13 of the included studies reported significant differences in at least one objective respiratory measure between groups (at rest). Scores on self-reported measures of dysnpea and breathlessness were higher in patients compared to healthy controls, while objective respiratory outcomes were varied. CONCLUSION: The current systematic review is consistent with previous literature suggesting more pronounced experiences of breathlessness in patients with PSS, and significant disparities between reported dyspnea and objective respiratory outcomes. Research investigating the uncoupling between subjective and objective respiratory outcomes is needed to understand the mechanisms behind breathing disturbances in PSS.

Psychological risk factors of somatic symptom disorder: A systematic review and meta-analysis of cross-sectional and longitudinal studies.

OBJECTIVE: Current diagnostic concepts of somatic symptom disorder (SSD) in DSM-5 and bodily distress disorder (BDD) in ICD-11 require certain psychological criteria, but researchers have called for further specification. Therefore, in a first step, this systematic review and meta-analysis aimed to summarize the current evidence on psychological factors associated with SSD/BDD and/or disorder-relevant clinical outcomes such as symptom severity and impairment. METHODS: Psychological factors were systematically searched using Pubmed, Cochrane Library and Psycinfo via EBSCO. Studies providing original data in English or German, after 2009 were included. Cross-sectional, cohort and case-control studies investigating at least one psychological factor in individuals with SSD/BDD in the context of disorder-relevant outcomes were included. RESULTS: Forty-three eligible studies (n = 3760 patients) in SSD (none in BDD) provided data on at least one psychological factor, 37 in case-control format, 10 cross-sectional and 5 longitudinal. Meta-analyses of the case-control studies found patients with SSD to be more impaired by depression (SMD = 1.80), anxiety (SMD = 1.55), health anxiety (SMD = 1.31) and alexithymia (SMD = 1.39), compared to healthy controls. Longitudinal results are scarce, mixed, and require refining, individual studies suggest self-concept of bodily weakness, anxiety and depression to be predictive for persistent SSD and physical functioning. CONCLUSION: This review provides a detailed overview of the current evidence of psychological factors in relation to SSD/BDD. Future studies on SSD and BDD should include under-studied psychological factors, such as negative affect, fear avoidance, or emotion regulation. More longitudinal studies are needed to assess the predictive value of these factors.

The burden of persistent symptom diagnoses in primary care patients: a cross-sectional study.

INTRODUCTION: The burden of symptoms is a subjective experience of distress. Little is known on the burden of feeling unwell in patients with persistent symptom diagnoses. The aim of this study was to assess the burden in primary care patients with persistent symptom diagnoses compared to other primary care patients. METHODS: A cross-sectional study was performed in which an online survey was sent to random samples of 889 patients with persistent symptom diagnoses (>1 year) and 443 other primary care patients after a transactional identification in a Dutch primary care data registry. Validated questionnaires were used to assess the severity of symptoms (PHQ-15), Symptom Intensity and Symptom Interference questionnaires, depression (PHQ-9), anxiety (GAD-7), quality of life (SF-12 and EQ-5D-5L)) and social functioning (SPF-ILs). RESULTS: Overall, 243 patients completed the survey: 178 (73.3%) patients in the persistent symptom diagnoses group and 65 (26.7%) patients in the control group. In the persistent group, 65 (36.5%) patients did not have persistent symptom(s) anymore according to the survey response. Patients who still had persistent symptom diagnoses (n = 113, 63.5%) reported significantly more severe somatic symptoms (mean difference = 3.6, [95% CI: 0.24, 4.41]), depression (mean difference = 3.0 [95% CI: 1.24, 3.61]) and anxiety (mean difference = 2.3 [95% CI: 0.28, 3.10]) and significantly lower physical functioning (mean difference = - 6.8 [95% CI: -8.96, -3.92]). CONCLUSION: Patients with persistent symptom diagnoses suffer from high levels of symptoms burden. The burden in patient with persistent symptoms should not be underestimated as awareness of this burden may enhance person-centered care.

Cognitive-behavioral therapy for patients with post-COVID-19 condition (CBT-PCC): a feasibility trial.

BACKGROUND: The post-COVID-19 condition describes the persistence or onset of somatic symptoms (e.g. fatigue) after acute COVID-19. Based on an existing cognitive-behavioral treatment protocol, we developed a specialized group intervention for individuals with post-COVID-19 condition. The present study examines the feasibility, acceptance, and effectiveness of the program for inpatients in a neurological rehabilitation setting. METHODS: The treatment program comprises eight sessions and includes psychoeducational and experience-based interventions on common psychophysiological mechanisms of persistent somatic symptoms. A feasibility trial was conducted using a one-group design in a naturalistic setting. N = 64 inpatients with a history of mild COVID-19 that fulfilled WHO criteria for post-COVID-19 condition were enrolled. After each session, evaluation forms were completed and psychometric questionnaires on somatic and psychopathological symptom burden were collected pre- and post-intervention. RESULTS: The treatment program was well received by participants and therapists. Each session was rated as comprehensible and overall satisfaction with the sessions was high. Pre-post effect sizes (of standard rehabilitation incl. new treatment program; intention-to-treat) showed significantly reduced subjective fatigue (p < 0.05, dav = 0.33) and improved disease coping (ps < 0.05, dav = 0.33-0.49). CONCLUSIONS: Our results support the feasibility and acceptance of the newly developed cognitive-behavioral group intervention for individuals with post-COVID-19 condition. Yet, findings have to be interpreted cautiously due to the lack of a control group and follow-up measurement, the small sample size, and a relatively high drop-out rate.

Public and patient involvement in the development of an internet-based guide for persistent somatic symptoms (GUIDE.PSS): A qualitative study on the needs of those affected.

BACKGROUND: Persistent somatic symptoms (PSS) frequently remain under-treated in health care settings. Evidence-based services that lead affected individuals to early guideline-based care are currently missing. This study aimed to identify the needs of those affected concerning an internet-based guide. The second aim was to evaluate public and patient involvement (PPI). METHODS: Participants experiencing PSS for at least 6 months were recruited via hospitals, psychotherapeutic practices and self-help organizations. Qualitative data were gathered via ideation discussions and prioritization tasks. Thematic analysis was conducted to gain insight on the needs of people with lived experiences. PPI was quantitatively evaluated with the Public and Patient Engagement Evaluation Tool. RESULTS: A total of 12 individuals participated (eight females, ages 22-66 years, duration of symptoms 1-43 years). Participants wanted to feel more supported, validated, in control and engaged with managing their health. Content-related preferences included education, self-help, social support and contact addresses. The majority of participants (>90%) experienced their involvement as worthwhile. CONCLUSIONS: To the best of our knowledge, this is one of the first studies describing PPI in intervention development for PSS. The involvement was perceived as a valuable contribution to the development process. PATIENT OR PUBLIC CONTRIBUTION: Adults with lived experiences were involved at the level of collaboration through the establishment of a participatory research team (PRT) and at the level of consultation through a workshop series, including one of the coauthors. They were involved in developing and validating intervention material and checking data interpretation.

Psychological risk factors for Long COVID and their modification: study protocol of a three-arm, randomised controlled trial (SOMA.COV).

BACKGROUND: Growing evidence suggests that in addition to pathophysiological, there are psychological risk factors involved in the development of Long COVID. Illness-related anxiety and dysfunctional symptom expectations seem to contribute to symptom persistence. AIMS: With regard to the development of effective therapies, our primary aim is to investigate whether symptoms of Long COVID can be improved by a targeted modification of illness-related anxiety and dysfunctional symptom expectations. Second, we aim to identify additional psychosocial risk factors that contribute to the persistence of Long COVID, and compare them with risk factors for symptom persistence in other clinical conditions. METHOD: We will conduct an observer-blinded, three-arm, randomised controlled trial. A total of 258 patients with Long COVID will be randomised into three groups of equal size: targeted expectation management in addition to treatment as usual (TAU), non-specific supportive treatment plus TAU, or TAU only. Both active intervention groups will comprise three individual online video consultation sessions and a booster session after 3 months. The primary outcome is baseline to post-interventional change in overall somatic symptom severity. CONCLUSIONS: The study will shed light onto the action mechanisms of a targeted expectation management intervention for Long COVID, which, if proven effective, can be used stand-alone or in the context of broader therapeutic approaches. Further, the study will enable a better understanding of symptom persistence in Long COVID by identifying additional psychological risk factors.

Healthcare-related factors influencing symptom persistence, deterioration, or improvement in patients with persistent somatic symptoms: A scoping review of European studies.

OBJECTIVE: This scoping review explored healthcare-related factors associated with symptom persistence, deterioration, or improvement in patients with persistent somatic symptoms (PSS) across Europe. METHODS: Articles were systematically searched in PubMed, Web of Science, Cochrane Library, and PsycINFO by combining terms of PSS and healthcare-related factors. Studies published in English, German, Polish, or Dutch between 2000 and 2022 were included. Healthcare-related factors associated with PSS symptom course were investigated, and study quality assessed (Center for Evidence-Based Medicine Checklist, Newcastle-Ottawa Scale). RESULTS: Of 8386 identified studies, 56 were included in the analysis. A significant knowledge gap was evident, as most studies lacked comprehensive healthcare descriptions with particularly unclear definitions of "treatments as usual" in RCTs. The only extractable healthcare factor according to Andersen's Behavioral Model was the treatment setting. Rates of PSS improvement split by care-levels were 38% in primary, 44% in secondary, 25% in mixed, and 71% in specialized care. Persistence rates were 57%, 50%, 75%, and 29% respectively. Deterioration was observed in 5% of primary and 6% of secondary care studies. Studies were skewed toward the United Kingdom, Germany, and the Netherlands. CONCLUSIONS: This scoping review shed light on the association between care levels and symptom outcomes in PSS patients. However, limited information in the current studies constrained our exploration of associations with other factors and symptom outcomes. Important aspects, like care availability, referral processes, and insurance coverage, are yet to be elucidated. Addressing these gaps is pivotal for developing targeted treatments across Europe, ultimately enhancing PSS patients' outcomes.

Helpful explanatory models for persistent somatic symptoms (HERMES): Results of a three-arm randomized-controlled pilot trial.

OBJECTIVE: This three-arm randomized controlled trial aimed to test the efficacy of an etiological model for persistent somatic symptoms (PSS) translated into video-animated explanatory models in comparison to a control group, and to examine additional value of personalization of the explanatory models (i.e. possibility to choose information based on mechanisms of symptom persistence). METHODS: Outpatients with PSS were shown one of three 15-min video animations: a) explanatory model without personalization, b) explanatory model with personalization, c) no explanatory model control group. Changes in somatic symptom severity (PHQ-15) and psychological burden related to somatic symptoms or associated health concerns (SSD-12) from baseline to one-month follow-up were the primary outcome. Health-related quality of life (SF-12) and perceived usefulness (USE) were also assessed. RESULTS: Seventy-five patients with PSS were allocated to the study arms (Mage = 44.2 ± 13.3 years, 56% female). The study arms did not differ significantly on the primary outcomes. However, no explanatory model participants reported significantly greater mental quality of life improvements than explanatory model without personalization participants (Mdiff = 7.50 [0.43; 14.56]). Further, explanatory model with personalization participants rated the individual fit of the intervention significantly higher than no explanatory model participants (Mdiff = 2.05 [0.17; 3.93]). All groups rated credibility of the intervention as very high. CONCLUSION: The HERMES materials seemed to have been too brief to improve symptom related outcomes. However, all three interventions were positively evaluated regarding their usefulness, particularly in case of additional personalization. Future studies should investigate potential effects of an increased intervention dose. TRIAL REGISTRATION: DRKS00018803.

The cost-effectiveness of an indicated blended care intervention in primary care compared to usual care in patients with moderate persistent somatic symptoms.

INTRODUCTION: Appropriate treatment for people with an increased risk for developing chronic Persistent Somatic Symptoms (PSS) is of great importance at an early stage to improve quality of life and prevent high costs for society. OBJECTIVE: To evaluate the cost-effectiveness of an integrated blended care intervention compared to usual care for QALYs, subjective symptom impact and physical and mental health status in patients with moderate PSS. METHODS: This economic evaluation was conducted alongside a 12-month prospective, multicenter cluster randomized controlled trial in Dutch primary care. 80 participants received the intervention and 80 participants received usual care. Seemingly unrelated regression analyzes were performed to estimate cost and effect differences. Missing data were imputed using multiple imputation. Bootstrapping techniques were used to estimate uncertainty. RESULTS: We found no significant difference in total societal costs. Intervention, primary and secondary healthcare and absenteeism costs were higher for the intervention group. The ICER for QALYs demonstrated the intervention was on average less costly and less effective compared to usual care. For the subjective symptom impact and physical health, the ICER indicated that the intervention group was on average less costly and more effective. For mental health, the intervention was on average more costly and less effective. CONCLUSION: We didn't find an integrated blended primary care intervention to be cost-effective compared to usual care. However, when looking on relevant, but specific outcome measures (subjective symptom impact and physical health) for this population, average costs are found to be lower and the effectiveness found to be higher.

Exploring maladaptive cognitions and behaviors as perpetuating factors in patients with persistent somatic symptoms: a longitudinal study.

OBJECTIVE: Maladaptive cognitions and behaviors may influence symptoms and impairment in patients with persistent somatic symptoms (PSS). Aims of this study were to examine: (i) whether maladaptive cognitions and behaviors are associated with symptom severity and functional health over time; (ii) if these associations are the result of changes within individuals over time or of differences between individuals; (iii) directions of changes within individuals over time. METHODS: Longitudinal data of a heterogeneous sample of patients with PSS were analyzed (n = 322 patients enrolled in the PROSPECTS cohort study). Cognitive and behavioral responses to symptoms (CBRQ), symptom severity (PHQ-15) and physical and mental functioning (RAND-36 PCS and MCS) were assessed seven times over a five-year period (0, 6 months, 1, 2, 3, 4, 5 year). Longitudinal mixed model and hybrid model analysis with and without time-lag were applied. RESULTS: Maladaptive cognitions and behaviors were associated with more severe symptoms and reduced physical and mental functioning over time. Both changes within individuals over time and differences between individuals were associated with higher symptom severity and reduced physical and mental functioning. The between-subject component was about twice the effect size of the within-subject component. Changes in several specific maladaptive cognitions and behaviors were associated with more severe symptoms and reduced physical and mental functioning later in time and vice versa. CONCLUSION: This study shows that maladaptive cognitions and behaviors are associated with symptom severity and reduced physical and mental functioning over time in patients with PSS.