Study protocol for virtual leisure investigating the effect of virtual reality-delivered stress reduction, entertainment and distraction on the use of coercion and need-based medication and patient satisfaction at a closed psychiatric intensive care unit - a mixed-methods pilot clinical trial.

INTRODUCTION: The environment at a psychiatric inpatient ward can lead to emotional distress and behavioural deviations in vulnerable individuals potentially resulting in conflicts, increased use of need-based medication and coercive actions, along with low satisfaction with treatment. To accommodate these challenges, recreational and entertaining interventions are recommended. The tested interventions have, however, shown varying effects and demand a high degree of planning and staff involvement while being difficult to adapt to individual needs. Virtual reality (VR) may help overcome these challenges. METHODS AND ANALYSIS: The study is a mixed-methods clinical trial with a target sample of 124 patients hospitalised at a closed psychiatric ward in the capital region of Denmark. Outcomes (eg, coercion, need-based medication and perceived stress) for a 12-month period where all patients are offered VR-based recreational experiences during their hospitalisation will be compared with outcomes for a 12-month period where VR is not offered. Feasibility and acceptability will be explored with qualitative interviews supplemented with non-participant observations and focus groups. The study began on 1 January 2023, and we expect to complete data collection by 31 December 2024. ETHICS AND DISSEMINATION: The study is registered at Danish Data Protection Agency (j.no P-2022-466) and is approved by the Committee on Health Research Ethics of the capital region of Denmark (j.no 22013313). All patients will be required to provide informed consent. Results from this study will be disseminated via peer-reviewed journals and congress/consortium presentations. TRIAL REGISTRATION NUMBER: NCT05654740.

Danish translation and validation of Kessler's 10-item psychological distress scale - K10.

BACKGROUND: Psychological distress is a trans-diagnostic feature of mental suffering closely associated with mental disorders. Kessler's 10-item Psychological Distress Scale (K10), a scale with sound psychometric properties, is widely used in epidemiological studies. AIM: To translate and investigate whether K10 is a reliable and valid rating scale for the measurement of psychological distress in a Danish population. METHODS: The translation was carried out according to official WHO translation guidelines. A sample of 100 subjects was included, 54 patients from the regional Mental Health Service (MHS) and 46 subjects with no psychiatric history. All participants were assessed with a psychiatric diagnostic interview (MINI) and handed out K10. Concurrent validity was assessed by WHO Well-being Index (WHO-5). Correlation matrix analysis was conducted for the full sample and receiver operating characteristic (ROC) curves for discriminating mental health service affiliation. RESULTS: Mean K10 scores differed, with decreasing levels, between inpatients and outpatient in MHS and the subjects with no psychiatric history. Factor analysis confirmed a unidimensional structure, and Cronbach's alpha and Omega showed excellent internal reliability. AUC for the K10 ROC curves showed excellent sensitivity (0.947 [0.900-0.995]), accurately differentiating mental health from non-mental health patients. CONCLUSION: The Danish K10 has the same strong internal reliability as the original English version, and scores differ between psychiatric patients in outpatient and emergency ward settings. CLINICAL IMPLICATIONS: The Danish K10 translation is authorized and freely available for download at https://www.hcp.med.harvard.edu/ncs/k6_scales.php . The utility as an instrument for clinical screening in a mental healthcare setting is supported.