Development and Evaluation of Cognitive Analytic Guided Self-Help (CAT-SH) for Use in IAPT Services.

BACKGROUND: There is a lack of treatment plurality at step 2 of Improving Access to Psychological Therapies (IAPT) services. This project therefore sought to develop and pilot a cognitive analytic informed guided self-help treatment for mild-to-moderate anxiety for delivery by Psychological Wellbeing Practitioners (PWPs). METHOD: Medical Research Council treatment development guidelines were used. Phase I included development of the six-session treatment manual using practice guidelines, small-scale modelling (n = 3) and indicated manual iterations. Phase II consisted of a mixed methods case series design (n = 11) to index feasibility, uptake and clinical outcomes. RESULTS: Cognitive analytic guided self-help (CAT-SH) met established quality parameters for guided self-help. A high treatment completion rate was observed, with 10/11 patients who attended the first treatment session subsequently completing full treatment. Six out of ten patients completing full treatment met reliable recovery criteria at follow-up. Effect sizes and recovery rates equate with extant PWP outcome benchmarks. Practitioner feedback indicated that delivery of CAT-SH was feasible. CONCLUSION: CAT-SH shows promise as a low-intensity treatment for anxiety, and so further, larger and more controlled evaluations are indicated

Group cognitive analytic music therapy: a quasi-experimental feasibility study conducted in a high secure hospital

This study conducted a feasibility patient preference quasi-experimental study of group cognitive analytic music therapy (G-CAMT) for mentally disordered offenders. Participants either chose or were randomised to 16 sessions of manualised G-CAMT (N = 10) plus treatment as usual (TAU) or TAU alone (N = 10). Self-rated and staff-rated outcomes were assessed at baseline, post-intervention and 8-weeks post-intervention. Residency was assessed at 2-year follow-up. Results indicate that G-CAMT was easily implemented; 9/10 participants completed G-CAMT and attendees had high satisfaction with the approach. Session attendance was high; 4/10 participants attended all sessions. At the 8-week follow-up, 3/9 G-CAMT participants had reliable reductions (i.e. statistically reliable pre to 8-week follow-up change results) in intrusive/possessive behaviours and fear of separation/abandonment. On the staff-rated outcome measure G-CAMT participants as a group were statistically significantly friendlier compared to TAU at 8-week follow-up (U = 0.50, p = 0.009, d = 1.92, CI 0.44 to 3.11). There were no differences between the arms in terms of residency outcomes at 2-year follow-up. The study is discussed in terms of G-CAMT’s theoretical grounding and high acceptability. The study is limited by its small sample size, but indicates the possibility of progressing onto a full trial

The Role of Practitioner Resilience and Mindfulness in Effective Practice: A Practice-Based Feasibility Study.

A growing body of literature attests to the existence of therapist effects with little explanation of this phenomenon. This study therefore investigated the role of resilience and mindfulness as factors related to practitioner wellbeing and associated effective practice. Data comprised practitioners (n = 37) and their patient outcome data (n = 4980) conducted within a stepped care model of service delivery. Analyses employed benchmarking and multilevel modeling to identify more and less effective practitioners via yoking of therapist factors and nested patient outcomes. A therapist effect of 6.7 % was identified based on patient depression (PHQ-9) outcome scores. More effective practitioners compared to less effective practitioners displayed significantly higher levels of mindfulness as well as resilience and mindfulness combined. Implications for policy, research and practice are discussed

Efficacy and safety of baricitinib or ravulizumab in adult patients with severe COVID-19 (TACTIC-R): a randomised, parallel-arm, open-label, phase 4 trial

Background From early in the COVID-19 pandemic, evidence suggested a role for cytokine dysregulation and complement activation in severe disease. In the TACTIC-R trial, we evaluated the efficacy and safety of baricitinib, an inhibitor of Janus kinase 1 (JAK1) and JAK2, and ravulizumab, a monoclonal inhibitor of complement C5 activation, as an adjunct to standard of care for the treatment of adult patients hospitalised with COVID-19. Methods TACTIC-R was a phase 4, randomised, parallel-arm, open-label platform trial that was undertaken in the UK with urgent public health designation to assess the potential of repurposing immunosuppressants for the treatment of severe COVID-19, stratified by a risk score. Adult participants (aged ≥18 years) were enrolled from 22 hospitals across the UK. Patients with a risk score indicating a 40% risk of admission to an intensive care unit or death were randomly assigned 1:1:1 to standard of care alone, standard of care with baricitinib, or standard of care with ravulizumab. The composite primary outcome was the time from randomisation to incidence (up to and including day 14) of the first event of death, invasive mechanical ventilation, extracorporeal membrane oxygenation, cardiovascular organ support, or renal failure. The primary interim analysis was triggered when 125 patient datasets were available up to day 14 in each study group and we included in the analysis all participants who were randomly assigned. The trial was registered on ClinicalTrials.gov (NCT04390464). Findings Between May 8, 2020, and May 7, 2021, 417 participants were recruited and randomly assigned to standard of care alone (145 patients), baricitinib (137 patients), or ravulizumab (135 patients). Only 54 (39%) of 137 patients in the baricitinib group received the maximum 14-day course, whereas 132 (98%) of 135 patients in the ravulizumab group received the intended dose. The trial was stopped after the primary interim analysis on grounds of futility. The estimated hazard ratio (HR) for reaching the composite primary endpoint was 1·11 (95% CI 0·62–1·99) for patients on baricitinib compared with standard of care alone, and 1·53 (0·88–2·67) for ravulizumab compared with standard of care alone. 45 serious adverse events (21 deaths) were reported in the standard-of-care group, 57 (24 deaths) in the baricitinib group, and 60 (18 deaths) in the ravulizumab group. Interpretation Neither baricitinib nor ravulizumab, as administered in this study, was effective in reducing disease severity in patients selected for severe COVID-19. Safety was similar between treatments and standard of care. The short period of dosing with baricitinib might explain the discrepancy between our findings and those of other trials. The therapeutic potential of targeting complement C5 activation product C5a, rather than the cleavage of C5, warrants further evaluation