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Purpose <p>The STRATA randomised-controlled trial (RCT) examined the antidepressant sertraline vs placebo for treating anxiety in autistic adults. Autistic people are often assumed to be reluctant to take part in RCTs due to intolerance of their inherent uncertainty. This study aimed to qualitatively examine autistic people’s experiences of RCT participation, specifically regarding their random assignment to an antidepressant (sertraline) or placebo for their mental health, whilst blinded to treatment allocation.</p> Methods <p>Semi-structured interviews were undertaken with a purposive sample of 62 STRATA participants. The interviews examined why they chose to take part, why they continued in the trial and/or discontinued medication, and their overall experience of participation. Interviews took place either during participation, or at participants’ final trial appointment at 52-weeks post randomisation (‘exit interviews’). Data were analysed thematically through a collaborative process, with multiple researchers independently coding, discussing, and refining themes.</p> Results <p>Interviewees often discussed improved anxiety, attributing changes to believing they were taking sertraline, experiencing the placebo effect, or external factors. Post-analysis unblinding revealed that improved anxiety was discussed equally by participants in both the sertraline and placebo groups. Some participants, including those taking placebo, experienced side effects, which mirrored the types, frequency, and severity seen in the general population. Many were able to manage these and continue, but some discontinued medication as a result.</p> Conclusion <p>Aspects of trial design and delivery facilitated continuation with the study medication, including frequent appointments, shared control over medication dose, and meaningfully involving autistic people in trial design. Such non-pharmacological factors may enhance therapeutic benefits, and may improve RCT design and therapeutic alliances with autistic people.</p>

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A Qualitative Study of the Treatment Experiences of Autistic Adults Allocated to Sertraline or Placebo for Anxiety in a Blinded Randomised Controlled Trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月18日

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  • Jade Eloise Norris,
  • Alba X. Realpe,
  • Ava Lorenc,
  • Leonora Cotton,
  • Zoe Morgan,
  • Dheeraj Rai,
  • Nicola Mills,
  • Jake Alberts,
  • Regi Alexander,
  • Lucy Allender,
  • Ayomipo Jeremiah Amiola,
  • Wendy Andrusjak,
  • Sharon Aujla,
  • Sarah Baillon,
  • David Baldwin,
  • Ariska Barbosa,
  • Meera Bentley,
  • Gaurav Bhattarai,
  • Asit Biswas,
  • Monalisa Bora-White,
  • Traolach Brugha,
  • Emma Butler,
  • Alison Cape,
  • David Carmichael,
  • Suzee Chang,
  • Jack Cheshire,
  • Madeleine Cochrane,
  • Leonora Cotton,
  • Abbie Cottrell,
  • Claire Cree,
  • Joshua Cudworth,
  • Conor Davidson,
  • Amy Davis,
  • Joy Fellows Davis,
  • Maria Del Piccolo,
  • Didiana dos Santos,
  • Sarah Douglas,
  • Jacqueline Dziewanowska,
  • Katie Ewart,
  • Sana Fatima,
  • Kerry Flahive,
  • Sharmistha Ghosh,
  • Emma Glasson,
  • Amy Green,
  • Lisa Hackney,
  • Catherine Haig,
  • Peter Hale,
  • Solveig Haselbach,
  • Katherine Hatch,
  • Bradleigh Hayhow,
  • Angela Holland,
  • Emma Horne,
  • Martin House,
  • Stephanie Howard,
  • Don Hulme,
  • Kathryn Janes,
  • Laura Jenkins,
  • Abhishek Jha,
  • Rose Jones,
  • Alwyn Kam,
  • David Kessler,
  • Puja Kochhar,
  • Ganesh Kunjithapatham,
  • Peter Langdon,
  • Liz Lenaghan,
  • Helen Leonard,
  • Amanda Lewis,
  • Holly Livesey,
  • Keri Lodge,
  • Laura Lord,
  • Ava Lorenc,
  • Charlotte Mackney-Hudson,
  • Stephanie MacNeill,
  • Alice Madden,
  • Charlotte Maplanka,
  • Jonathan Martin,
  • Liz McCullagh,
  • Tim Medlicott,
  • Nicola Mills,
  • Maximiliano Vazquez Morales,
  • Zoe Morgan,
  • Jeremy Mudunkotuwe,
  • Raja Mukherjee,
  • Sowmy Murickal,
  • Anneka Newman,
  • Victoria Nimmo-Smith,
  • Krist Noonan,
  • Jade Eloise Norris,
  • Sarah O’Brien,
  • Katrina Or,
  • Sarah Parkinson,
  • Alex Parsons,
  • Rani Pathania,
  • Gisela Perez-Olivas,
  • Rebekah Pole,
  • Karen Poon,
  • Sunita Procter,
  • Dheeraj Rai,
  • Prasanna Rajbhandari,
  • Alba X Realpe,
  • Jemma Regan,
  • Ailsa Russell,
  • Aws Sadik,
  • Inder Sawhney,
  • Hafsa Sheikh,
  • Susan Smith,
  • Sujata Soni,
  • Ashkan Sowhani,
  • Holly Spray,
  • Sergio Starkstein,
  • Jodi Taylor,
  • Eleanor Teo,
  • Brionne Thomas,
  • Joanna Thorn,
  • Samuel Tromans,
  • Eleni Tsappis,
  • Nicholas Turner,
  • Amy Walker,
  • Doug Webb,
  • Jack Welch,
  • Nicola Wiles,
  • Alexandra Young

摘要

Purpose

The STRATA randomised-controlled trial (RCT) examined the antidepressant sertraline vs placebo for treating anxiety in autistic adults. Autistic people are often assumed to be reluctant to take part in RCTs due to intolerance of their inherent uncertainty. This study aimed to qualitatively examine autistic people’s experiences of RCT participation, specifically regarding their random assignment to an antidepressant (sertraline) or placebo for their mental health, whilst blinded to treatment allocation.

Methods

Semi-structured interviews were undertaken with a purposive sample of 62 STRATA participants. The interviews examined why they chose to take part, why they continued in the trial and/or discontinued medication, and their overall experience of participation. Interviews took place either during participation, or at participants’ final trial appointment at 52-weeks post randomisation (‘exit interviews’). Data were analysed thematically through a collaborative process, with multiple researchers independently coding, discussing, and refining themes.

Results

Interviewees often discussed improved anxiety, attributing changes to believing they were taking sertraline, experiencing the placebo effect, or external factors. Post-analysis unblinding revealed that improved anxiety was discussed equally by participants in both the sertraline and placebo groups. Some participants, including those taking placebo, experienced side effects, which mirrored the types, frequency, and severity seen in the general population. Many were able to manage these and continue, but some discontinued medication as a result.

Conclusion

Aspects of trial design and delivery facilitated continuation with the study medication, including frequent appointments, shared control over medication dose, and meaningfully involving autistic people in trial design. Such non-pharmacological factors may enhance therapeutic benefits, and may improve RCT design and therapeutic alliances with autistic people.