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Background: Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed to manage anxiety in adults with an autism diagnosis. However, their effectiveness and adverse effect profile in the autistic population are not well known. This trial aims to determine the effectiveness and cost-effectiveness of the SSRI sertraline in reducing symptoms of anxiety and improving quality of life in adults with a diagnosis of autism compared with placebo and to quantify any adverse effects. Methods: STRATA is a two-parallel group, multi-centre, pragmatic, double-blind, randomised placebo-controlled trial with allocation at the level of the individual. It will be delivered through recruiting sites with autism services in 4 regional centres in the United Kingdom (UK) and 1 in Australia. Adults with an autism diagnosis and a Generalised Anxiety Disorder Assessment (GAD-7) score ≥ 10 at screening will be randomised 1:1 to either 25 mg sertraline or placebo, with subsequent flexible dose titration up to 200 mg. The primary outcome is GAD-7 scores at 16 weeks post-randomisation. Secondary outcomes include adverse effects, proportionate change in GAD-7 scores including 50% reduction, social anxiety, obsessive-compulsive symptoms, panic attacks, repetitive behaviours, meltdowns, depressive symptoms, composite depression and anxiety, functioning and disability and quality of life. Carer burden will be assessed in a linked carer sub-study. Outcome data will be collected using online/paper methods via video call, face-to-face or telephone according to participant preference at 16, 24 and 52 weeks post-randomisation, with brief safety checks and data collection at 1–2, 4, 8, 12 and 36 weeks. An economic evaluation to study the cost-effectiveness of sertraline vs placebo and a QuinteT Recruitment Intervention (QRI) to optimise recruitment and informed consent are embedded within the trial. Qualitative interviews at various times during the study will explore experiences of participating and taking the trial medication. Discussion: Results from this study should help autistic adults and their clinicians make evidence-based decisions on the use of sertraline for managing anxiety in this population. Trial registration: ISRCTN, ISRCTN15984604. Registered on 08 February 2021. EudraCT 2019-004312-66. ANZCTR ACTRN12621000801819. Registered on 07 April 2021. [ABSTRACT FROM AUTHOR]

Aim: To describe the service use and clinical outcomes associated with the implementation of a complex intervention designed to improve care for people with depression in a primary care setting. Background: Health systems have limited capacity to provide appropriate psychological and pharmacological treatments for people with depression. Guidance on the treatment of depression in primary care in the United Kingdom was clarified by the National Institute for Clinical Excellence in 2004. However, there is little evidence so far of substantial changes in practice: anti-depressant prescriptions continue to rise, there is limited access to psychological therapies and uncertainty persists about who should be treated for what and how. Although the welfare of staff is critical to their therapeutic engagement with patients, this is rarely an explicit focus of health systems design. Method: An observational study examining the implementation of a complex intervention to improve depression care called 'Doing Well', based in 14 general practices in a mixed urban-rural area in Scotland, United Kingdom. A small team of clinicians implemented a programme for people with low mood, depression and adjustment disorder, based on primary care. This programme incorporated a number of changes in standard mental health care, including the following: no 'severity threshold' for referral to secondary care; routine use of an objective measure of depression severity with continuous outcome monitoring; prompt access to guided self-help; prompt 'step-up' care to more formal psychological therapy or medical care, if indicated; and careful attention to staff training and satisfaction. Findings: There was good fidelity to the model of care designed by the programme. There was a high demand for the new service (1.8% of the catchment population each year) but the programme had the capacity to manage this adequately. Clinical outcomes were satisfactory, and antidepressant use adhered to the guidelines. [ABSTRACT FROM AUTHOR]