Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial
Rai, Dheeraj Webb, Doug Lewis, Amanda Cotton, Leonora Norris, Jade Eloise Baldwin, David S Brugha, Traolach S Cochrane, Madeleine Del Piccolo, Maria Chiara
Rai, Dheeraj
Webb, Doug
Lewis, Amanda
Cotton, Leonora
Norris, Jade Eloise
Baldwin, David S
Brugha, Traolach S
Cochrane, Madeleine
Del Piccolo, Maria Chiara
Citations
Altmetric:
Affiliation
University of Bristol; NIHR Bristol Biomedical Research Centre; Avon & Wiltshire Partnership Mental Health NHS Trust; Hertfordshire Partnership NHS Foundation Trust; University of Southampton; University of Leicester; Surrey and Borders Partnership NHS Foundation Trust; University of Western Australia; University of Warwick; Coventry and Warwickshire Partnership NHS Trust; University of Bath; Dorset County Hospital NHS Foundation Trust
Other Contributors
Publication date
2024-01-11
Subject
Research Projects
Organizational Units
Journal Issue
Abstract
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.
Citation
Rai D, Webb D, Lewis A, Cotton L, Norris JE, Alexander R, Baldwin DS, Brugha T, Cochrane M, Del Piccolo MC, Glasson EJ, Hatch KK, Kessler D, Langdon PE, Leonard H, MacNeill SJ, Mills N, Morales MV, Morgan Z, Mukherjee R, Realpe AX, Russell A, Starkstein S, Taylor J, Turner N, Thorn J, Welch J; STRATA autistic advisory group; Wiles N. Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial. Trials. 2024 Jan 11;25(1):37. doi: 10.1186/s13063-023-07847-3. PMID: 38212784; PMCID: PMC10782796.
Type
Article