Contents
Why is the study being done?
Many autistic adults experience anxiety and many find it very difficult to deal with. Medications like sertraline are often prescribed for anxiety in autistic adults but whether they work, and what their side effects are in the autistic population is not well known. By taking part in this study, you will be helping to inform whether autistic adults who experience anxiety should be prescribed sertraline.
This study has been designed by experienced researchers and clinicians, with the help of an advisory group of autistic adults. The study will recruit 306 participants over 2 years from the UK (see also University of Western Australia). You can take part entirely remotely (for example using email, telephone, and video-calling), with medication sent out by post, so you can take part wherever you live in the UK.
What is involved if I take part?
Participants will receive either sertraline, or a placebo (inactive) medication which they will be asked to take for up to one year. Participants will be contacted briefly via video call, telephone, text or email (whichever they prefer) 4 times in the first 4 months, and again after 9 months to see how they are getting on with the medication.
Participants will also complete questionnaires about their anxiety and other symptoms at the start of the study, and after 4 months, 6 months, and 1 year, and will be offered a £10 gift voucher for completing these.
If you were to take part, you can withdraw from the study at any time, without giving a reason, and without it affecting your medical care or legal rights.
Who can take part?
To be potentially eligible, you need to:
- be aged 18 years or over and have a diagnosis of autism (including autism spectrum disorder/condition or other variations, Asperger syndrome, or pervasive developmental disorder)
- experience anxiety for which you are willing to try treatment with medication
- be able to complete online or paper-based questionnaires about things such as your anxiety, other symptoms, and healthcare usage
- be able to provide informed consent to take part
The study may not be suitable for you to take part in if you are/have:
- currently taking medication(s) for depression and/or anxiety, or have taken them in the past 8 weeks, or are using St John’s Wort
- have a moderate or severe learning disability which means you may not be able to provide informed consent and/or understand and complete the study questionnaires
- have/had other mental health conditions such as bipolar disorder or psychosis
- epilepsy that is not well controlled
- current problematic use of alcohol or illicit drugs
- allergies to sertraline or placebo
- severe liver problems, bleeding disorders, some heart problems, swallowing difficulties, or are unable to take medication in capsule form
- taking part in another clinical trial
- pregnant, planning pregnancy during the study period, or breastfeeding
Expressing an Interest
Once you have read the information above, as well as the Participant Information Leaflet/s below, and discussed the study with family/friends/carers/others if you wish, please express an interest in taking part by completing a quick form HERE.
- If you would prefer to complete the Expression of Interest on paper, or over the phone with a member of the team, please contact us to request a posted paper copy: strata-takepart@bristol.ac.uk 0117 428 3001.
Please contact the STRATA study team by email: strata-takepart@bristol.ac.uk or phone 0117 428 3001 if there are any parts of the study information that you do not understand, you have any questions, or you would like further information.
Participant Information Leaflet V2.0
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Information About Sertraline
You can read information about Sertraline here.