Title {1}	Sertraline for anxiety in adults with a diagnosis of autism (STRATA): Study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial.
Trial registration {2a and 2b}.	ISRCTN: 15984604 (08-Feb-2021); ANZCTR: ACTRN12621000801819 (07-Apr-2021).
Protocol version {3}	Version 7.0, 31 August 2023.
Funding {4}	National Institute for Health Research Health Technology Assessment (NIHR127337); National Health and Medical Research Council (NHMRC GNT1171206).
Author details {5a}	Dheeraj Rai1,2,3, Doug Webb1,4, Amanda Lewis1,4, Leonora Cotton1,4, Jade Eloise Norris1,4, Regi Alexander5, David S Baldwin6, Traolach Brugha7, Madeleine Cochrane1,4, Maria Chiara Del Piccolo8, Emma J Glasson9,10, Katherine K Hatch10, David Kessler1,2, Peter E Langdon11, 12, Helen Leonard9,10, Stephanie J MacNeill1,2,4, Nicola Mills1,2, Maximiliano Vazquez Morales,1,4, Zoe Morgan7, Raja Mukherjee8, Alba X Realpe1,2,4, Ailsa Russell13, Sergio Starkstein10, Jodi Taylor1,4, Nicholas Turner1,4, Joanna Thorn1,4, Jack Welch14 on behalf of the STRATA autistic advisory group*, Nicola Wiles1,2. 1. Population Health Sciences, University of Bristol 2. NIHR Bristol Biomedical Research Centre 3. Avon & Wiltshire Partnership Mental Health NHS Trust 4. Bristol Trials Centre, University of Bristol 5. Hertfordshire Partnership NHS Foundation Trust 6. Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton 7. University of Leicester 8. Surrey and Borders Partnership NHS Foundation Trust 9. Telethon Kids Institute, The University of Western Australia 10. Discipline of Psychiatry, Medical School, The University of Western Australia 11. Centre for Research in Intellectual and Developmental Disabilities, University of Warwick 12. Coventry and Warwickshire Partnership NHS Trust 13. Centre for Applied Autism Research, Department of Psychology, University of Bath 14. Dorset County Hospital NHS Foundation Trust
Name and contact information for the trial sponsor {5b}	Adam Taylor, Head of Research Governance, Research and Enterprise Development, University of Bristol, Senate House Tyndall Ave, Bristol, BS8 1TH. Telephone: 0117 42 83065. Email: research-governance@bristol.ac.uk Australia Centre Sponsor: The University of Western Australia (M459), 35 Stirling Highway, Crawley, Perth, Western Australia 6009. Telephone: + 61 8 6488 4260.
Role of sponsor {5c}	The sponsor is responsible for research governance and providing oversight to the study as defined in the UK Policy Framework for Health and Social Care Research. The sponsor or study funders are not involved in study design or in collection, management, analysis, or interpretation of data, or the decision to submit for publication.