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.

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.

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.