BackgroundBehavioural and cognitive interventions remain credible approaches in addressing loneliness and depression. There was a need to rapidly generate and assimilate trial-based data during COVID-19.ObjectivesWe undertook a parallel pilot RCT of behavioural activation (a brief behavioural intervention) for depression and loneliness (Behavioural Activation in Social Isolation, the BASIL-C19 trialISRCTN94091479). We also assimilate these data in a living systematic review (PROSPERO CRD42021298788) of cognitive and/or behavioural interventions.MethodsParticipants (≥65 years) with long-term conditions were computer randomised to behavioural activation (n=47) versus care as usual (n=49). Primary outcome was PHQ-9. Secondary outcomes included loneliness (De Jong Scale). Data from the BASIL-C19 trial were included in a metanalysis of depression and loneliness.FindingsThe 12 months adjusted mean difference for PHQ-9 was −0.70 (95% CI −2.61 to 1.20) and for loneliness was −0.39 (95% CI −1.43 to 0.65).The BASIL-C19 living systematic review (12 trials) found short-term reductions in depression (standardised mean difference (SMD)=−0.31, 95% CI −0.51 to −0.11) and loneliness (SMD=−0.48, 95% CI −0.70 to −0.27). There were few long-term trials, but there was evidence of some benefit (loneliness SMD=−0.20, 95% CI −0.40 to −0.01; depression SMD=−0.20, 95% CI −0.47 to 0.07).DiscussionWe delivered a pilot trial of a behavioural intervention targeting loneliness and depression; achieving long-term follow-up. Living meta-analysis provides strong evidence of short-term benefit for loneliness and depression for cognitive and/or behavioural approaches. A fully powered BASIL trial is underway.Clinical implicationsScalable behavioural and cognitive approaches should be considered as population-level strategies for depression and loneliness on the basis of a living systematic review.
Background Depression is common in people with long-term health conditions, and this combination can lead to worsened health outcomes and increased health-care costs. Subthreshold depression, a risk factor for major depression, is prevalent in this population, but many people remain untreated due to the demand on services. The community pharmacy may be an alternative setting to offer mental health support; however, insufficient evidence exists to support implementation. Objectives To conduct a feasibility study and pilot randomised controlled trial of a community pharmacy-delivered psychological intervention aimed at preventing depression in adults with long-term health conditions. Design A feasibility study with nested qualitative evaluation and an external pilot, two-arm, 1 : 1 individually randomised controlled trial with nested process and economic evaluations. Setting Community pharmacies in the north of England. Participants Adults aged ≥ 18 years with subthreshold depression and at least one long-term health condition. Intervention A bespoke enhanced support intervention (behavioural activation within a collaborative care framework) involving up to six sessions delivered by trained community pharmacy staff (intervention facilitators) compared with usual care. Main outcome measures Recruitment and retention rates, completeness of outcome measures and intervention engagement. The intended primary outcome was depression severity at 4 months, assessed by the Patient Health Questionnaire-9. Results In the feasibility study, 24 participants were recruited. Outcome measure completeness was 95–100%. Retention at 4 months was 83%. Seventeen participants (71%) commenced intervention sessions and all completed two or more sessions. Depression symptoms reduced slightly at 4 months. The process evaluation suggested that the intervention was acceptable to participants and intervention facilitators. In the pilot randomised controlled trial, 44 participants (target of 100 participants) were randomised (intervention, n = 24; usual care, n = 20). Outcome measure completeness was 100%. Retention at 4 months was 93%. Eighteen participants (75%) commenced intervention sessions and 16 completed two or more sessions. Depression symptoms reduced slightly at 4 months, with a slightly larger reduction in the usual-care arm, although the small sample size limits any conclusions. The process evaluation reported good acceptability of the intervention and identified barriers associated with study implementation and its impact on core pharmacy functions. The economic analysis revealed some indication of reduced resource use/costs associated with the intervention, but this is limited by the small sample size. Intervention costs were low. Limitations The main limitation is the small sample size due to difficulties with recruitment and barriers to implementing the study within existing pharmacy practices. Conclusions The community pharmacy represents a new setting to deliver a depression prevention intervention. Recruitment was a challenge and pharmacy staff encountered barriers to effective implementation of the study within busy pharmacy practice. Despite these challenges, good retention rates and intervention engagement were demonstrated, and process evaluation suggested that the intervention was acceptable in this setting. To the best of our knowledge, this is the first study to demonstrate that community pharmacy staff can be trained to deliver a depression prevention intervention. Future work Further work is needed to address barriers to recruitment, intervention delivery and implementation of psychological interventions in the community pharmacy setting. Trial registration This trial is registered as ISRCTN11290592. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 10, No. 5. See the NIHR Journals Library website for further project information.
BackgroundBehavioural and cognitive interventions remain a credible approach in preventing loneliness and depression. There was a need to rapidly generate and assimilate trial-based data during COVID-19.ObjectivesWe undertook a COVID-19 parallel pilot RCT of behavioural activation for depression and loneliness [the BASIL-C19 trial ISRCTN94091479]. We also assimilate these data in a COVID-19 living systematic review [PROSPERO CRD42021298788].MethodsPrimary care participants (>=65 years) with long-term conditions were computer randomised to Behavioural Activation (n=47) versus care-as-usual (n=49). The single blinded primary outcome was the PHQ-9. Secondary outcomes included loneliness (De Jong Gierveld Scale). Data from the BASIL-C19 trial were included in a random effects meta-analysis of depression and loneliness.FindingsThe 12 months adjusted mean difference for PHQ-9 was -0.70 (95% CI -2.61 to 1.20) and for loneliness was -0.39 (95% CI -1.43 to 0.65). Secondary 12-month trial outcomes suggested evidence of benefit for behavioural activation.The BASIL-C19 meta-analysis (13 trials) found short-term reductions in depression (standardised mean difference [SMD]=-0.31, 95%CI -0.51 to -0.11) and loneliness (SMD=-0.48, 95%CI -0.70 to -0.27). There were few long-term trials, but there was evidence of some benefit (loneliness SMD=-0.20, 95%CI -0.40 to -0.01; depression SMD=-0.20, 95%CI -0.47 to 0.07).DiscussionWe found a signal of effect in reducing loneliness and depression in the BASIL trial. Living meta-analysis provides strong evidence of short-term benefit for loneliness and depression.Clinical implicationsScalable behavioural and cognitive approaches should be considered as population-level strategies for depression and loneliness on the basis of the living systematic review.FundingThis study was funded by National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research (PGfAR) RP-PG-0217-20006.Author summaryWhy was this study done?⍰Older people with long-term conditions have been impacted by COVID-19 pandemic restrictions and have experienced social isolation. In turn, this puts them at risk for depression and loneliness, and these are bad for health and wellbeing. Psychosocial approaches, such as behavioural activation, could be helpful.⍰Trial-based evidence is needed to demonstrate if it is possible to prevent the onset, or mitigate the impact, of loneliness and depression.⍰There are few studies of brief psychosocial interventions to mitigate depression and loneliness, and it is important to know how emerging trial-based data adds to existing evidence.What did the researchers do and find?⍰There was preliminary evidence that levels of loneliness were reduced at 3 months when behavioural activation was offered.⍰At longer term (12-month) follow-up there were signals of ongoing positive impact.⍰When BASIL-C19 data were assimilated into a living systematic review there is clear evidence of impact of brief psychological interventions on depression and loneliness in the short-term. More research into the longer-term impact is needed.What does all this mean?⍰Behavioural activation now shows evidence of benefit which will be useful for policy makers in offering support to people who are socially isolated.⍰This research knowledge will be useful once the COVID-19 pandemic has passed, since loneliness is common in older populations and effective scalable solutions will be needed to tackle this problem.⍰As new trial-based data emerges, our living systematic review and meta-analysis will be updated since this is an area of active research.
A459peridone. Methods: Cost-utility analysis was performed using a Markov model. The primary outcome was ICER/QALY. Oral risperidone, oral paliperidone and long-acting risperidone were selected as comparators. The basic components of the model include probabilities of relapse, individual hazard ratios for non-compliance by medication type and switch of treatment probabilities. Specific utilities for each health state were considered. Among relevant costs, reflecting payer's perspective, drug acquisition costs, monitoring costs, costs of relapses, follow-up care and adverse events were considered. Results: Long-acting paliperidone reached ICER of EUR 16,233/QALY compared to oral risperidone, EUR 15,058/QALY to oral paliperidone and EUR 335/QALY to long-acting risperidone. The robustness of the model was supported by one-way deterministic analysis and probabilistic sensitivity analysis, which gave stable results. Long-acting paliperidone was cost effective in 97% of the simulations compared to oral risperidone. Long-acting paliperidone treatment gained incremental 0.903 QALYs on average compared to oral risperidone. ConClusions: The treatment of schizophrenia using long-acting paliperidone is associated with increased QALYs. It reduces incidence of adverse events, results in better prevention of relapses and can be considered a cost-effective treatment in the Czech Republic. PMH34Cost-Utility of Vortioxetine in tHe treatMent of Major DePressiVe DisorDer: CoMParison witH agoMelatine, BUProPion, sertraline anD Venlafaxine in tHe finnisH setting
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