Participatory design of bodysymptoms.org: An interactive web resource to explain multisystem functional somatic symptoms.

OBJECTIVE: There is a lack of trustworthy information about Functional Somatic Symptoms (FSS) on the internet. This means integrative bio-psycho-social explanations of FSS and related health advice are not readily available to the public. To explore and address this problem, we carried out the bodysymptoms project, with the aim to build a website which presents current widely accepted explanations for FSS and shows how different explanations are inter-connected. METHODS: Bodysymptoms was set up as a research-in-action project with a diverse range of international stakeholder-participants, combining approaches from patient and public involvement in healthcare with participatory design. 7 participants with lived experience of multi-system functional symptoms took part in the project and measures of meaningful engagement throughout the project were rated highly. This manuscript describes the methodology by which the website was developed. RESULTS: Through iterative cycles we determined the requirements for an interactive explanatory model and co-created a novel online health interactive resource with integrated actionable health advice. The target end user are young adults with persistent physical symptoms, maintained by functional mechanisms. The overall aim is to empower people at risk of developing functional disorders to seek better health outcomes. The website is intended to be used prior to or alongside engagement with healthcare. CONCLUSION: Bringing lived experience and multi-disciplinary perspectives into dialogue through participatory design can harness the power of research to create immediate shared value. This project has resulted in a usable open access website, bodysymptoms.org, which provides education about FSS for patients, healthcare professionals and members of the public looking to understand FSS.

Efficacy of patient education and duloxetine, alone and in combination, for patients with multisystem functional somatic disorder: Study protocol for the EDULOX trial.

BACKGROUND: Multisystem functional somatic disorder is characterized by specific patterns of persistent physical symptoms with a complex biopsychosocial etiology. The disorder can lead to disability and personal suffering. Current treatment options require specialized settings, therefore patients often wait a long time to receive specific treatment. Patient education is considered important in most treatment programs, but has only been investigated sparsely as a stand-alone treatment. Pharmacological treatment is limited to tricyclic antidepressants in low doses with no antidepressant properties. Duloxetine has been found effective in single organ functional disorders. As a treatment for multisystem functional somatic disorder, duloxetine could reduce symptoms and treat comorbid anxiety and depression. It may furthermore enhance the effect of patient education through a hypothesized effect on cognitive functioning. The purpose of the EDULOX trial is to study psycho-EDUcation and duLOXetine alone and in combination. METHODS: This is a nested study design. The parent trial "EDULOX1" (n = 424) will compare a patient education program with enhanced usual care in an open-labelled, randomized controlled trial. In addition to this, eligible participants will furthermore receive either duloxetine or active placebo in the nested, double-blinded, randomized controlled trial, "EDULOX2" (n = 212). Patient and clinician reported outcomes will be collected through questionnaires. CONCLUSION: The EDULOX trial may establish evidence for treatments applicable for the majority of patients with multisystem functional somatic disorder. If effective, duloxetine would be a more tolerable pharmacological treatment option that can target comorbid depression and anxiety, and potentially boost the effect of patient education. Trial registration number The study is registered at www. CLINICALTRIALS: gov (NCT06232473) and the internal list of research projects at the Region of Central Denmark (Case number 1-16-02-305-23). Approval from the Danish Medical Research Ethics Committees (Case number: 2212291) and the Danish Medicines Agency was obtained under EudraCT Number: 2022-002780-30 and Sponsor's Protocol Code Number: 9515.

Internet-delivered treatment for patients suffering from severe functional somatic disorders: Protocol for a randomized controlled trial.

Background: Functional somatic disorders (FSDs) with symptoms from multiple organs, i.e., multi-system type, are common in the general population and may lead to disability and reduced quality of life. Evidence for efficient treatment programs has been established, however, there is a need for making treatments accessible to a larger group of patients. Internet-delivered therapy has become prevalent and has proven as effective as face-to-face therapy, while providing a flexible and easily accessible treatment alternative. The aim of the current study is to compare the efficacy of the therapist-assisted internet-delivered treatment program One step at a time (OneStep) with the internet-delivered self-help program Get started (GetStarted). Methods: A total of 166 participants aged 18-60 years diagnosed with multi-system FSD will be assessed and randomized to either 1) OneStep: a 14-week program consisting of 11 treatment modules based on principles from cognitive behavioural therapy or 2) GetStarted consisting of 1 module on psychoeducation. The primary outcome is physical health, assessed by a Short Form Health Survey (SF-36) aggregate score of the subscales vitality, physical functioning, and bodily pain 3 months after end-of-treatment and self-reported improvement assessed by the Clinical Global Improvement Scale. Secondary outcomes include symptom load, depression, anxiety, and illness worry. Process measures include emotional distress, illness perception, illness behaviour, and symptom interference. Conclusions: This study is the first study to test an internet-delivered treatment program for FSD, multi-system type and has the potential to show the importance of making evidence-based internet-delivered treatment for FSD more accessible.

Explanations for functional somatic symptoms across European treatment settings: A mixed methods study.

OBJECTIVE: Engaging patients in treatment for functional somatic symptoms (FSS) relies on a shared understanding of the mechanisms underlying the complaints. Despite this, little is known about the explanatory models used in daily clinical practice. We aim to examine the approaches healthcare professionals use to explain FSS across European healthcare settings. METHODS: This is an exploratory mixed methods study, combining sequential qualitative and quantitative analyses. 3 types of data were collected: a survey of Health-Care Professionals (HCPs) with special interest in FSS from 16 European countries (n = 186), Patient Education Material collected systematically from survey respondents (n = 72) and semi-structured Interviews with HCPs (n = 14). Survey results are summarized descriptively. Qualitative data was thematically coded following template analysis methods. Findings were integrated through mixed-methods triangulation. RESULTS: Five main explanatory models for FSS that are used across treatment settings and diagnostic constructs were represented in the data. The 'Multisystem Stress' Approach explains FSS through physiological stress responses within a bio-psycho-social paradigm. 'Sensitized Alarm' and 'Malfunctioning software' are both approaches derived from the neurosciences. Explanations related to 'Embodied Experience' are often used within integrated psychosomatic therapies. In the person-centred 'Symptoms' approach, HCPs aim for co-constructed, individualized explanations. These approaches, which rely on different models of mind-body-environment are complementary and are used flexibly by skilled HCPs. CONCLUSION: Taken together the explanatory models described might form the basis of a curriculum of medical explanation with the potential to equip clinicians to form more collaborative relationships with patients across healthcare.

Are study populations in trials of antidepressants and psychotherapy comparable? A retrospective case study of two parallel running trials for multi- organ functional somatic disorder.

This study retrospectively compares two previous parallel running, randomized, controlled trials of pharmacotherapy (imipramine) and psychotherapy (acceptance and commitment therapy) for multi-organ functional somatic disorder (FSD). Differences in demographics, psychiatric comorbidity, illness severity, and illness duration associated with eligibility for the two trials and patients' willingness to participate are explored using linear or binary regression models. 418 patients with multi-organ FSD was included. We found that 377 (95%) were eligible for psychotherapy and 257 patients (61%) for pharmacotherapy. Patients eligible for pharmacotherapy were less severely impaired, less often received disability pension, reported shorter illness duration and experienced less psychological distress than patients eligible for psychotherapy. Whilst exclusion criteria for both trials differed markedly, it was not possible to clearly identify patient or illness characteristics associated with patients' willingness to participate. The study showed that trial-specific exclusion criteria led to the selection of less complex and less severely impaired patients in the pharmacological trial in this sample of multi-organ FSD. Our findings have important implications for the interpretation and comparability of RCT results of different treatments in multi-organ FSD and may point to some common flaws in study design and interpretation of pharmacological vs. psychotherapeutic intervention trials in psychiatry.

Measuring Spiritual Needs in a Secular Society: Validation and Clinimetric Properties of the Danish 20-Item Spiritual Needs Questionnaire.

In secular cultures, such as Denmark, tools to measure spiritual needs are warranted to guide existential and spiritual care. We examined the clinimetric properties of the Danish version of the Spiritual Needs Questionnaire (DA-SpNQ-20) based on a digital survey in a test-retest setup. A convenience sample was reached via social media and student platforms. A total of 325 (148 for retest) respondents were included in the analysis. The sample was randomly split into two groups (A and B) and used for exploratory (EFA) and confirmatory factor analysis (CFA) by structural equation modeling, respectively. SpNQ dimensions had an internal consistency with Cronbach's alpha between 0.73 and 0.93. The four factors of the SpNQ were supported by both EFA and CFA as follows: religious needs, existential needs, inner peace needs, and generativity needs. The instrument showed good internal consistency, good test-retest reliability, and acceptable structural validity in the sample of relatively young and healthy persons.

Mental well-being, health, and locus of control in Danish adults before and during COVID-19.

AIM: The aim of this study was to investigate the possible impact of the Covid-19 pandemic on general health, mental well-being, and experiences of control compared to pre-pandemic populations. Our hypotheses were that we would observe a significantly lower level of psychological well-being and general health in the 2020 sample compared to the pre-pandemic samples, and that we would observe younger age groups to be the most affected. METHOD: Two representative Danish populations (2016, n = 1656) and (2017, n = 3366) were compared to a representative Danish population (2020, n = 1538) sampled during the first lockdown in May 2020. Two-tailed tests of proportions were used to investigate possible differences between samples in proportions reporting poorer mental well-being measured by 5-item World Health Organization Well-Being Index, general health, and internal locus of control. RESULTS: Younger men (aged 18-24) and younger women (aged 18-44) as well as elderly women (aged 65-74) reported lower mental well-being during the early phase of the pandemic compared to the population from 2016. Both women and men in 2020 reported significantly lower levels of internal locus of control compared to the 2017 sample. This was especially true for younger men and women. There were no statistically significant differences in general health between populations. DISCUSSION: This study partly supports the hypothesis that the Covid-19 pandemic affected mental well-being negatively among younger persons. However, longitudinal studies are needed to investigate possible long-term effects of the pandemic on mental health and well-being. Further, qualitative studies are needed to investigate the in-depth consequences of Covid-19.

The impact of the Covid-19 pandemic on mental and physical health in Denmark - a longitudinal population-based study before and during the first wave.

BACKGROUND: In the continuation of the first wave of the Covid-19 outbreak in Denmark, unprecedented restrictions with great impact on the citizen's everyday life were implemented. The objectives of this study were to investigate the influence of the Covid-19 pandemic on mental and physical health in the Danish population during the spring 2020 first wave outbreak and lockdown. METHODS: A sample from the adult Danish population (n = 2190) were included. Self-reported measures of illness worry (Whiteley-6-R), emotional distress (SCL-90), and physical symptom load (SLC-90) were obtained before and during the first wave of the pandemic and compared with Wilcoxon signed-rank tests. Impact of covariates on physical and mental health was evaluated with ordinal regression analyses. Results from a tailored questionnaire regarding the Covid-19 pandemic were presented to explore the direct impact of the pandemic. RESULTS: We only found minor increases in illness worry, emotional distress and physical symptom load (0-1 points difference, p ≤ 0.007) during the Covid-19 pandemic compared to before the pandemic. Sex, age, education, and physical disease were not associated with illness worry, emotional distress, or physical symptom load. Overall, the participants were trustful in the authorities' recommendations and felt that they managed the pandemic and the restrictions to a great extent despite that some expected great/major future consequences of the pandemic. CONCLUSIONS: This study suggested that the first wave of the Covid-19 pandemic only had minor impact on mental and physical health in the Danish general population. Future studies should address the impact of the second wave of the pandemic and the renewed implementation of the concomitant restrictions.

Acceptance and Commitment group Therapy for patients with multiple functional somatic syndromes: a three-armed trial comparing ACT in a brief and extended version with enhanced care.

BACKGROUND: Psychological treatment for functional somatic syndromes (FSS) has been found moderately effective. Information on how much treatment is needed to obtain improvement is sparse. We assessed the efficacy of a brief and extended version of group-based Acceptance and Commitment Therapy (ACT) v. enhanced care (EC) for patients with multiple FSS operationalised as Bodily Distress Syndrome multi-organ type. METHODS: In a randomised controlled three-armed trial, consecutively referred patients aged 20-50 with multiple FSS were randomly assigned to either (1) EC; (2) Brief ACT: EC plus 1-day workshop and one individual consultation; or (3) Extended ACT: EC plus nine 3-h group-based sessions. Primary outcome was patient-rated overall health improvement on the five-point clinical global improvement scale 14 months after randomisation. A proportional odds model was used for the analyses. RESULTS: A total of 180 patients were randomised; 60 to EC, 61 to Brief ACT, and 59 to Extended ACT. Improvement on the primary outcome after Extended ACT was significantly greater than after EC with an unadjusted OR of 2.9 [95% CI (1.4-6.2), p = 0.006]. No significant differences were found between Brief ACT and EC. Of the 18 secondary outcomes, the only significant difference found was for physical functioning in the comparison of Extended ACT with EC. CONCLUSIONS: Patients rated their overall health status as more improved after Extensive ACT than after EC; however, clinically relevant secondary outcome measures did not support this finding. Discrepancies between primary and secondary outcomes in this trial are discussed.

What brings meaning to life in a highly secular society? A study on sources of meaning among Danes.

This study presents psychometric properties of the Danish version of the Sources of Meaning and Meaning in Life Scale (SoMe-Da) and associations to socio-demographic and religious characteristics. Participants were 554 Danes, 66% women ranging in age between 15 and 91 years. Exploratory factor analysis (EFA) suggested a five factor structure for the 26 sources if meaning. Construct validity within the SoMe-Da and between mental health variables were established. Generativity associated most strongly with meaningfulness followed by spirituality, attentiveness, and explicit religiosity. We found religious characteristics to be more strongly associated with meaningfulness than socio-demographic variables. Finally, we found distinct patterns of preferred sources of meaning between Christians, agnostics, and atheists. Christians and agnostics seemed to be more motivated by self-transcendance, whereas atheists may be more motivated by self-actualization. Results indicate that the SoMe-Da appears to be a valid instrument for measuring the content and degree of personal meaning in life.