Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial
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...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2024-01-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07847-3 |
| _version_ | 1827382032258301952 |
|---|---|
| author | Dheeraj Rai Doug Webb Amanda Lewis Leonora Cotton Jade Eloise Norris Regi Alexander David S. Baldwin Traolach Brugha Madeleine Cochrane Maria Chiara Del Piccolo Emma J. Glasson Katherine K. Hatch David Kessler Peter E. Langdon Helen Leonard Stephanie J. MacNeill Nicola Mills Maximiliano Vazquez Morales Zoe Morgan Raja Mukherjee Alba X. Realpe Ailsa Russell Sergio Starkstein Jodi Taylor Nicholas Turner Joanna Thorn Jack Welch on behalf of the STRATA autistic advisory group Nicola Wiles |
| author_facet | Dheeraj Rai Doug Webb Amanda Lewis Leonora Cotton Jade Eloise Norris Regi Alexander David S. Baldwin Traolach Brugha Madeleine Cochrane Maria Chiara Del Piccolo Emma J. Glasson Katherine K. Hatch David Kessler Peter E. Langdon Helen Leonard Stephanie J. MacNeill Nicola Mills Maximiliano Vazquez Morales Zoe Morgan Raja Mukherjee Alba X. Realpe Ailsa Russell Sergio Starkstein Jodi Taylor Nicholas Turner Joanna Thorn Jack Welch on behalf of the STRATA autistic advisory group Nicola Wiles |
| author_sort | Dheeraj Rai |
| collection | DOAJ |
| description | 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. Trial registration ISRCTN, ISRCTN15984604 . Registered on 08 February 2021. EudraCT 2019-004312-66. ANZCTR ACTRN12621000801819. Registered on 07 April 2021. |
| first_indexed | 2024-03-08T14:13:38Z |
| format | Article |
| id | doaj.art-dcf5728c9f524919a95e54ac2b254489 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-08T14:13:38Z |
| publishDate | 2024-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-dcf5728c9f524919a95e54ac2b2544892024-01-14T12:35:26ZengBMCTrials1745-62152024-01-0125112010.1186/s13063-023-07847-3Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trialDheeraj Rai0Doug Webb1Amanda Lewis2Leonora Cotton3Jade Eloise Norris4Regi Alexander5David S. Baldwin6Traolach Brugha7Madeleine Cochrane8Maria Chiara Del Piccolo9Emma J. Glasson10Katherine K. Hatch11David Kessler12Peter E. Langdon13Helen Leonard14Stephanie J. MacNeill15Nicola Mills16Maximiliano Vazquez Morales17Zoe Morgan18Raja Mukherjee19Alba X. Realpe20Ailsa Russell21Sergio Starkstein22Jodi Taylor23Nicholas Turner24Joanna Thorn25Jack Welch26on behalf of the STRATA autistic advisory groupNicola Wiles27Population Health Sciences, University of BristolPopulation Health Sciences, University of BristolPopulation Health Sciences, University of BristolPopulation Health Sciences, University of BristolPopulation Health Sciences, University of BristolHertfordshire Partnership NHS Foundation TrustClinical and Experimental Sciences, Faculty of Medicine, University of SouthamptonUniversity of LeicesterPopulation Health Sciences, University of BristolSurrey and Borders Partnership NHS Foundation TrustTelethon Kids Institute, The University of Western AustraliaDiscipline of Psychiatry, Medical School, The University of Western AustraliaPopulation Health Sciences, University of BristolCentre for Research in Intellectual and Developmental Disabilities, University of WarwickTelethon Kids Institute, The University of Western AustraliaPopulation Health Sciences, University of BristolPopulation Health Sciences, University of BristolPopulation Health Sciences, University of BristolUniversity of LeicesterSurrey and Borders Partnership NHS Foundation TrustPopulation Health Sciences, University of BristolCentre for Applied Autism Research, Department of Psychology, University of BathDiscipline of Psychiatry, Medical School, The University of Western AustraliaPopulation Health Sciences, University of BristolPopulation Health Sciences, University of BristolPopulation Health Sciences, University of BristolDorset County Hospital NHS Foundation TrustPopulation Health Sciences, University of BristolAbstract 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.https://doi.org/10.1186/s13063-023-07847-3AutismAspergerAnxietyAdultsAntidepressantMental health |
| spellingShingle | Dheeraj Rai Doug Webb Amanda Lewis Leonora Cotton Jade Eloise Norris Regi Alexander David S. Baldwin Traolach Brugha Madeleine Cochrane Maria Chiara Del Piccolo Emma J. Glasson Katherine K. Hatch David Kessler Peter E. Langdon Helen Leonard Stephanie J. MacNeill Nicola Mills Maximiliano Vazquez Morales Zoe Morgan Raja Mukherjee Alba X. Realpe Ailsa Russell Sergio Starkstein Jodi Taylor Nicholas Turner Joanna Thorn Jack Welch on behalf of the STRATA autistic advisory group Nicola Wiles 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 Autism Asperger Anxiety Adults Antidepressant Mental health |
| title | Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial |
| title_full | Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial |
| title_fullStr | Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial |
| title_full_unstemmed | Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial |
| title_short | Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial |
| title_sort | sertraline for anxiety in adults with a diagnosis of autism strata study protocol for a pragmatic multicentre double blind placebo controlled randomised controlled trial |
| topic | Autism Asperger Anxiety Adults Antidepressant Mental health |
| url | https://doi.org/10.1186/s13063-023-07847-3 |
| work_keys_str_mv | AT dheerajrai sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT dougwebb sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT amandalewis sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT leonoracotton sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT jadeeloisenorris sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT regialexander sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT davidsbaldwin sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT traolachbrugha sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT madeleinecochrane sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT mariachiaradelpiccolo sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT emmajglasson sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT katherinekhatch sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT davidkessler sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT peterelangdon sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT helenleonard sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT stephaniejmacneill sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT nicolamills sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT maximilianovazquezmorales sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT zoemorgan sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT rajamukherjee sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT albaxrealpe sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT ailsarussell sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT sergiostarkstein sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT joditaylor sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT nicholasturner sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT joannathorn sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT jackwelch sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT onbehalfofthestrataautisticadvisorygroup sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial AT nicolawiles sertralineforanxietyinadultswithadiagnosisofautismstratastudyprotocolforapragmaticmulticentredoubleblindplacebocontrolledrandomisedcontrolledtrial |