Pragmatic cluster randomized controlled trial evaluating the effectiveness and cost effectiveness of the early youth engagement intervention in early intervention in psychosis services

Background: Early Intervention in Psychosis services improve outcomes for young people with psychosis but a significant proportion disengage with potential costs to their mental health. Method(s): This study evaluated effectiveness and cost-effectiveness of the EYE-2 intervention, a motivational engagement intervention, delivered by EIP clinicians, compared to standardized EIP (sEIP) in a cluster RCT in 20 EIP teams in 5 sites across England. Participants were 1027 young people with first episode psychosis. The primary outcome was time to disengagement. Economic outcomes were NHS mental health and wider societal costs, clinical and social outcomes and cost-effectiveness. Result(s): The adjusted hazard ratio for EYE-2 + sEIP versus sEIP alone was 1.07, (95% CI 0.76 to 1.49;p = .713). Disengagement was 16% with no observed differences between arms for any secondary outcomes. The health economic evaluation indicated lower average mental health costs [-543 (95% CI -2715 to 1628)] and marginally improved mental health states, with a 63% probability of the EYE-2 intervention being dominant in cost-effectiveness compared to usual care. There were very tentative indications of lower societal costs and better social outcomes with 30 more days per year spent in education and training (95% CI 1.52 to 53.68;probability positive outcome for the intervention: 99%) in a sub-sample of 22% of participants. Conclusion(s): Cost-effectiveness analyses revealed estimates in the direction of dominance of EYE-2, but 95% confidence limits ruled out a reduction of more than 24% in the risk of disengagement. Implementation, fidelity and COVID-19 impacts are discussed.

The implementation of a digital group intervention for individuals with subthreshold borderline personality disorder

Context: Systems Training for Emotional Predictability and Problem Solving for Emotional Intensity (STEPPS-EI), a 13-week skills-based group intervention for individuals with subthreshold borderline personality disorder (BPD) has been deemed feasible and clinically effective in primary care [1] [2]. To modernize the service, STEPPS-EI lesson content has recently built onto an eHealth platform (Minddistrict). Due to Covid-19 restrictions, group sessions were additionally delivered remotely via Zoom. This project evaluates the implementation of this digitally blended version of STEPPS-EI within two Sussex Partnership NHS Foundation Trust (SPFT) primary care services. Methods: Service users and pracitioners who participated in the first two groups from March to July 2021 were invited to take part in a feasibility evaluation investigating recruitment, retention, and attendance rates, in addition to self-reported symptoms (BSL-23, QuEST), quality of life (ReQoL), system usability, and qualitative and quantitative measures designed to shed light on the experience and opinions of service users and practitioners during the intervention. Service users participating in following groups (from July to December 2021) were invited to share their symptom and quality of life outcome data only. Results: 14 service users and 5 practitioners agreed to take part in the primary evaluation. Results suggested that 86% of these service users attended at least 75% of the group sessions, and that service users completed on average 70% of the online material. Usability ratings revealed good gradings for Zoom from all participants, yet lower gradings for Minddistrict. Further analyses revealed a generally positive attitude towards digital STEPPS-EI from all parties and practical suggestions on how to improve the intervention. 11 service users from following groups agreed to share their data. Bayesian analyses were conducted for the data of service users who provided ratings at both timepoints. Evidence was found for a decrease in BSL-23 scores and an increase in ReQoL ratings from baseline to post-intervention. Incomplete self-report data-sets limits conclusions. Conclusions: It was found that the implementation of STEPPS-EI delivered in a blended digital format was feasible. The online delivery might increase service users' engagement with the material and group sessions. Yet more training and support on the use of Minddistrict may be required to increase usability. Implications: It may be possible to effectively implement digital interventions for individuals with subthreshold BPD. However, more research on the effect of these on symptom outcomes should follow. © 2022 Elsevier B.V.. All rights reserved.

A multilevel intervention increased accrual of Native Hawaiians and other Pacific Islanders to a national breast cancer screening trial

Background: The University of Hawaii Cancer Center (UHCC) Minority/Underserved NCI Community Oncology Research Program (Hawaii MU NCORP) provides access to NCI-sponsored clinical trials in Hawaii. The Hawaii MU NCORP is dedicated to increasing minority and underserved accruals to clinical trials. Native Hawaiian women have the highest breast cancer incidence and mortality;only 26% of Micronesian women in Hawaii over the age of 40 have ever had a mammogram. In 2018, the Hawaii MU NCORP became a recruitment site for the ECOG-ACRIN Tomosynthesis Mammographic Imaging Screening Trial (TMIST). A pilot study was launched in 2019, to support our NCORP recruitment of underrepresented Native Hawaiian and other Pacific Islander (NHPI) women to the TMIST study. Subsequently, specific funding was provided by the NCI's Center to Reduce Cancer Health Disparities that enabled the UHCC's Office of Community Outreach and Engagement (COE) to develop an effective multilevel recruitment strategy together with the Hawaii MIU NCORP. Methods: To foster community awareness of the TMIST study among NHPI women, the UHCC COE hired a Community Health Educator (CHE). The CHE, a Pacific Islander woman, utilized small group educational sessions to provide culturally and linguistically appropriate cancer prevention information and promote the TMIST study to NHPI women in Hawaii. The CHE worked in partnership with Hawaii MU NCORP clinical research associates (CRAs) in these efforts. In 2020, statewide COVID-19 health and safety protocols were enacted, limiting public group interactions in Hawaii. Despite this challenge, the CHE successfully adapted the in-person educational sessions on clinical trials and TMIST to conduct sessions using Zoom and Facebook Messenger. Results: Before the hire of the CHE in 2019, only one Pacific Islander (Micronesian) woman was recruited to the TMIST in Hawaii. The CHE conducted 21 community health events with 426 attendees from 2019 to 2021. The Hawaii MU NCORP NHPI TMIST enrollment went from the 9.9% in 2018 to 2019, to 20.1% in 2019 to 2020 and to 33% in 2020 to 2021. To date, 18 Micronesian, 52 Native Hawaiian and 6 Other Pacific Islander women out of 353 participants ware enrolled. Conclusions: The multilevel intervention of our CHE, in collaboration with NCORP staff providing clinical trial awareness training and community outreach, resulted in increasing the enrollment of NHPI women to the TMIST Trial. CHE-led community health education sessions on cancer prevention can be delivered using emergent technologies and social media. The use of culturally and gender concordant CHEs working with CRAs have the potential to increase awareness and accruals to cancer clinical trials.

Increasing access to cognitive–behavioural therapy for patients with psychosis by evaluating the feasibility of a randomised controlled trial of brief, targeted cognitive–behavioural therapy for distressing voices delivered by assistant psychologists: the GiVE2 trial

Background Cognitive-behavioural therapy (CBT) is recommended for all patients with psychosis, but is offered to only a minority. This is attributable, in part, to the resource-intensive nature of CBT for psychosis. Responses have included the development of CBT for psychosis in brief and targeted formats, and its delivery by briefly trained therapists. This study explored a combination of these responses by investigating a brief, CBT-informed intervention targeted at distressing voices (the GiVE intervention) administered by a briefly trained workforce of assistant psychologists. Aims To explore the feasibility of conducting a randomised controlled trial to evaluate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists to patients with psychosis. Method This was a three-arm, feasibility, randomised controlled trial comparing the GiVE intervention, a supportive counselling intervention and treatment as usual, recruiting across two sites, with 1:1:1 allocation and blind post-treatment and follow-up assessments. Results Feasibility outcomes were favourable with regard to the recruitment and retention of participants and the adherence of assistant psychologists to therapy and supervision protocols. For the candidate primary outcomes, estimated effects were in favour of GiVE compared with supportive counselling and treatment as usual at post-treatment. At follow-up, estimated effects were in favour of supportive counselling compared with GiVE and treatment as usual, and GiVE compared with treatment as usual. Conclusions A definitive trial of the GiVE intervention, delivered by assistant psychologists, is feasible. Adaptations to the GiVE intervention and the design of any future trials may be necessary.

Use of intravenous immunoglobulin therapy reduces progression to mechanical ventilation in COVID-19 patients with moderate to severe hypoxia

Background: The majority of COVID-19 morbidity and mortality occurs in patients who progress to mechanical ventilation. Therefore, therapeutic interventions targeting the mitigation of this complication would markedly improve outcomes and reduce healthcare utilization. Methods: Patients with COVID-19 from two hospitals in San Diego, California were randomized at a 1:1 ratio to receive standard of care (SOC) plus intravenous immunoglobulin (IVIG) at 0.5 g/kg/day x 3 days with solumedrol 40 mg 30 minutes before infusion (IVIG group) versus SOC alone. The primary composite endpoint was receipt of mechanical ventilation or death before receiving ventilation. Patients were followed until discharge to home or up to 30 days from time of enrollment. Results: Sixteen patients received IVIG plus SOC and 17 SOC alone. The median age was 54 years for SOC and 57 years for IVIG. Median time from hospital admission to study enrollment was 1 day (range 0-4) for SOC and 2 days (range 0-8) for IVIG. APACHE II scores and Charlson comorbidity indices were similar for IVIG and SOC (median 8 vs 7 and 2 for both, respectively). Seven SOC patients achieved the composite endpoint (6 ventilated, 1 death) versus 2 IVIG patients (2 ventilated), p=0.12, Fisher exact test. Among the subgroup with an estimated A-a gradient of >200 mm Hg at time of enrollment, the IVIG group showed a lower rate of progression to the composite endpoint (2/14 vs 7/12, p=0.04 Fisher exact test), shorter median hospital length (11 vs 24 days, p=0.001 Mann Whitney U), and shorter median intensive care unit (ICU) stay (3 vs 13 days, p=0.005 Mann Whitey U). Conclusion: This small, prospective, randomized, open-label study showed that when administered to hypoxic non-ventilated COVID-19 patients with an A-a gradient of >200 mm Hg (corresponding to a requirement of 6 liters O2 via nasal cannula to achieve an SpO2 of 92%), IVIG significantly decreased the rates of progression to mechanical ventilation, ICU length of stay, and total hospital length of stay. A Phase 3 prospective, randomized, placebo-controlled, multicenter trial is underway to further validate these findings.