About the study

SerTRaline for AnxieTy in adults with a diagnosis of Autism. A randomised controlled trial (STRATA)

The STRATA study aims to find out whether the medication sertraline is an effective treatment for anxiety in adults with a diagnosis of autism. We are interested to see whether sertraline reduces symptoms of anxiety, enhances quality of life, and is effective in the longer term.

We are also interested in understanding side effects of the treatment, what people think about being invited to the study, and their experiences of taking part in it.

Anxiety is common in autistic adults and many find it to be very disabling. Medications like sertraline are commonly prescribed for anxiety in autistic adults but whether they work, and what their side effects are in the autistic population is not well known. Although such medications are well studied in the non-autistic population, those research findings may not apply to autistic adults.

It is important that any medication prescribed to autistic adults is based on research evidence. Better research into interventions for mental health conditions in autistic people was recently identified as the “number one priority” by autistic people and other stakeholders. The National Institute for Health Research (NIHR) identified this area as a major gap in the evidence and funded this study.

This study will be the largest of its kind and will therefore provide evidence to inform whether sertraline has a role in managing anxiety in autistic adults. STRATA has been designed by experienced researchers and clinicians, with the help of an advisory group of five autistic adults.

We are now unable to accept any further Expressions of Interest for the STRATA study. Thank you very much for your interest. 

Introduction to the STRATA study by Prof Dheeraj Rai, STRATA Principal Investigator:


Jack Welch, representative for the Autistic Advisory Group and Trial Management Group discussing how autistic people are involved in STRATA:


Follow us on Twitter: @BristolStrata


This study is funded by the National Institute for Health Research (NIHR) HTA Programme (Ref: 127337). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

The authors and University of Western Australia acknowledge funding from the National Health and Medical Research Council (Project Grant 1171206). The contents of the published material/website are solely the responsibility of the authors and do not reflect the views of NHMRC.

The Bristol Randomised Trials Collaboration, a UK Clinical Research Collaboration (UKCRC) registered trials unit, as part of the Bristol Trials Centre, supports the delivery and conduct of the study.