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Psychosomatic therapy for patients frequently attending primary care with medically unexplained symptoms, the CORPUS trial: study protocol for a randomised controlled trial

Background: Medically unexplained symptoms (MUS) are highly prevalent and pose a burden both on patients and on health care. In a pilot study psychosomatic therapy delivered by specialised therapists for patients with MUS showed promising results with regard to patient’s acceptability, feasibility and effects on symptoms. The aim of this study is to establish whether psychosomatic therapy by specialised psychosomatic exercise therapists is costeffective in decreasing symptoms and improving functioning in patients who frequently consult their general practitioner (GP) with MUS. Methods: A randomised effectiveness trial with an economic evaluation in primary care with 158 patients aged 18 years and older who are frequently consulting their GP with MUS. Patients will be assigned to psychosomatic therapy in addition to usual care or usual care only. Psychosomatic therapy is a multi-component and tailored intervention, aiming to empower patients by applying psycho-education, relaxation techniques, mindfulness, cognitive approaches and/or graded activity. Patients assigned to the psychosomatic therapy receive 6 to 12 sessions of psychosomatic therapy, of 30–45 min each, delivered by a specialised exercise or physical therapist. Primary outcome measure is patient-specific functioning and disability, measured with the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are symptom severity, consultation frequency and referrals to secondary care, patient satisfaction, quality of life and costs. Assessments will be carried out at baseline, and after 4 and 12 months. An economic evaluation alongside the trial will be conducted from a societal perspective, with quality-adjusted life years (QALYs) as outcome measure. Furthermore, a mixed-methods process evaluation will be conducted. Discussion: We expect that psychosomatic therapy in primary care for patients who frequently attend the GP for MUS will improve symptoms and daily functioning and disability, while reducing consultation frequency and referrals to secondary care. We expect that the psychosomatic therapy provides value for money for patients with MUS.Trial registration: Netherlands Trial Register, ID: NL7157 (NTR7356). Registered 13 July 2018.Keywords: Psychosomatic therapy, Study protocol, Primary care, Randomised controlled trial, Medically unexplained symptoms, Cost-effectiveness

Feasibility of a web-based cross-over paleolithic diet intervention in the general population

The primary aim was to investigate feasibility of a web-based cross-over Paleolithic diet intervention in the general population. The secondary aim was to calculate the sample size needed to reach a statistically significant difference in effect of a Paleolithic-like diet on psychological and somatic symptoms compared with the Dutch consensus diet.

Dutch homeless people 2.5 years after shelter admission

Housing stability is an important focus in research on homeless people. Although definitions of stable housing differ across studies, the perspective of homeless people themselves is generally not included. Therefore, this study explored the inclusion of satisfaction with the participant's current housing status as part of the definition of housing stability and also examined predictors of housing stability with and without the inclusion of homeless person's perspective. Of the initial cohort consisting of 513 homeless participants who were included at baseline in 2011, 324 (63.2%) were also interviewed at 2.5-year follow-up. To determine independent predictors of housing stability, we fitted multivariate logistic regression models using stepwise backward regression. At 2.5-year follow-up, 222 participants (68.5%) were stably housed and 163 participants (51.1%) were stably housed and satisfied with their housing status. Having been arrested (OR = 0.36, 95% CI: 0.20-0.63), a high level of somatisation (physical manifestations of psychological distress) (OR = 0.52, 95% CI: 0.30-0.91) and having unmet care needs (OR = 0.77, 95% CI: 0.60-0.99) were negative predictors of housing stability. Having been arrested (OR = 0.43, 95% CI: 0.25-0.75), high debts (OR = 0.45, 95% CI: 0.24-0.84) and a high level of somatisation (OR = 0.49, 95% CI: 0.28-0.84) were negative predictors of stable housing when satisfaction with the housing status was included. Because inclusion of a subjective component revealed a subgroup of stably housed but not satisfied participants and changed the significant predictors, this seems a relevant addition to the customary definition of housing stability. Participants with characteristics negatively associated with housing stability should receive more extensive and individually tailored support services to facilitate achievement of housing stability.

Demographic and health-related factors associated with reduced work functioning in people with moderate medically unexplained physical symptoms: a cross-sectional study

Background: Medically unexplained physical symptoms (MUPS) are a leading cause of reduced work functioning. It is not known which factors are associated with reduced work functioning in people with moderate MUPS. Insight in these factors can contribute to prevention of reduced work functioning, associated work-related costs and in MUPS becoming chronic. Therefore, the aim of this study was to identify which demographic and health-related factors are associated with reduced work functioning, operationalized as impaired work performance and absenteeism, in people with moderate MUPS. Methods: Data of 104 participants from an ongoing study on people with moderate MUPS were used in this cross-sectional study. Ten independent variables were measured at baseline to determine their association with reduced work functioning: severity of psychosocial symptoms (four domains, measured with the Four-Dimensional Symptom Questionnaire), physical health (RAND 36-Item Health Survey), moderate or vigorous physical activity (Activ8 activity monitor), age, sex, education level and duration of complaints. Two separate multivariable linear regression analyses were performed with backward stepwise selection, for both impaired work performance and absenteeism. Results: Absenteeism rate rose with 2.5 and 0.6% for every increased point on the Four-Dimensional Symptom Questionnaire for domain 'depression' (B = 0.025, SE = 0.009, p = .006) and domain 'somatization' (B = 0.006, SE = 0.003, p = .086), respectively. An R2 value of 0.118 was found. Impaired work performance rate rose with 0.2 and 0.5% for every increased point on the Four-Dimensional Symptom Questionnaire for domain 'distress' (B = 0.002, SE = 0.001, p = .084) and domain 'somatization' (B = 0.005, SE = 0.001, p < .001), respectively. An R2 value of 0.252 was found. Conclusions: Severity of distress, probability of a depressive disorder and probability of somatization are positively associated with higher rates of reduced work functioning in people with moderate MUPS. To prevent long-term absenteeism and highly impaired work performance severity of psychosocial symptoms seem to play a significant role. However, because of the low percentage of explained variance, additional research is necessary to gain insight in other factors that might explain the variance in reduced work functioning even better.

Towards understanding what Dutch people in a socio-economically disadvantaged position need to enhance their living conditions

This thesis has increased our knowledge of the needs of homeless people using shelter facilities in the Netherlands and of the needs and wishes of people living in persistent poverty. It provides guidance for policy and further professionalization and quality improvements to the services and support provided to homeless people and people living in persistent poverty. The results underscore the importance of broad and integrated policy measures to strengthen socioeconomic security, and emphasize the need for including the views of clients and experts by experience in the development of policy. Our research also stresses the need for services to employ peer workers to support homeless people and people living in persistent poverty and to apply a more human-to-human approach.

Cost-effectiveness of interventions for medically unexplained symptoms