Writing Committee for the REMAP-CAP Investigators IMPORTANCE The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.OBJECTIVE To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTSThe ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONSThe immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURESThe primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, −1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. RESULTS Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11...

Traumatic experiences are known to have a significant impact upon one’s physical and mental health. Post-traumatic stress disorder (PTSD) is understood to be a common mental health consequence of trauma. However, Complex Trauma and consequences of adverse childhood experiences appear more prevalent and a serious public health concern that hinders the individual’s daily existence, thus emphasising the need to implement a culturally free treatment intervention. In this chapter, we begin by introducing traumatic experiences in several contexts and explore the treatment for trauma. It will focus on a research study that employs Comprehend, Cope and Connect (CCC), a third wave CBT approach, to deliver a culturally free form of therapy that has been adapted for individuals from diverse populations. The CCC approach’s relevance to cultural adaptation is explained and discussed through the use of two case examples from the main study. The Culture Free study found that CCC was both feasible and acceptable in diverse populations, echoing existing research on cultural adaptations which found use of mindfulness to be accepted and appreciated as an effective intervention that can elicit concrete positive change across a broad range of mental health presentations, including trauma and trans-diagnostically. Further investigations utilising a robust methodology and powered sample are warranted in particular with diverse populations presenting with complex trauma.

BACKGROUND Recommendations for psychotherapy have evolved over the years, with cognitive behavioral therapy (CBT) taking precedence since its inception within clinical guidelines in the United Kingdom and United States. The use of CBT for severe mental illness is now more common globally. AIM To investigate the feasibility and acceptability of a culturally adapted, CBT-based, third-wave therapy manual using the Comprehend, Cope, and Connect approach with individuals from a diverse population presenting to primary and secondary healthcare services. METHODS A pilot study was used to assess the feasibility and acceptability of the manualised intervention. Outcome measures were evaluated at baseline, post-intervention and 12 wk-follow up. 32 participants with mental health conditions aged 20-53 years were recruited. Assessments were completed at three time points, using Clinical Outcomes in Routine Evaluation (CORE), Hospital Anxiety and Depression Scale (HADS), Bradford Somatic Inventory and World Health Organization Disability Assessment Schedule 2.0 (WHODAS). The Patient Experience Ques-tionnaire was completed post-treatment. RESULTS Repeated measures of analysis of variance associated with HADS depression, F (2, 36) = 12.81, P < 0.001, partial η 2 = 0.42 and HADS anxiety scores, F (2, 26) = 9.93, P < 0.001, partial η 2 = 0.36; CORE total score and WHODAS both showed significant effect F (1.25, 18.72) = 14.98, P < 0.001, partial η 2 = 0.5. and F (1.29, 14.18) = 6.73, P < 0.001, partial η 2 = 0.38 respectively. CONCLUSION These results indicate the effectiveness and acceptability of the culturally adapted, CBT-based, third-wave therapy manual intervention among minoritized groups with moderate effect sizes. Satisfaction levels and acceptability were highly rated. The viability and cost-effectiveness of this approach should be explored further to support universal implementation across healthcare systems.