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Protocol for a feasibility study and randomised pilot trial of a low-intensity psychological intervention for depression in adults with autism: the Autism Depression Trial (ADEPT)
  1. Ailsa Russell1,
  2. Kate Cooper1,
  3. Stephen Barton2,3,
  4. Ian Ensum4,
  5. Daisy Gaunt5,
  6. Jeremy Horwood5,
  7. Barry Ingham6,7,
  8. David Kessler8,
  9. Chris Metcalfe5,
  10. Jeremy Parr7,
  11. Dheeraj Rai8,
  12. Nicola Wiles9
  1. 1 Department of Psychology, University of Bath, Bath, UK
  2. 2 Newcastle Cognitive and Behaviour Therapies (CBT) Centre, Northumberland Tyne & Wear NHS Foundation Trust, Newcastle upon Tyne, UK
  3. 3 School of Psychology, Newcastle University, Newcastle upon Tyne, United Kingtom
  4. 4 Bristol Adult Autism Services, Avon and Wiltshire Mental Health Partnership NHS Trust, Chippenham, UK
  5. 5 Population Health Sciences, Bristol Randomised Trials Collaboration, Bristol Medical School, University of Bristol, Bristol, UK
  6. 6 Northumberland, Tyne & Wear NHS Foundation Trust, Northumberland, UK
  7. 7 Institute of Neuroscience, University of Newcastle, Newcastle, UK
  8. 8 Population Health Sciences, School of Social and Community Medicine, Bristol Medical School, University of Bristol, Bristol, UK
  9. 9 Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
  1. Correspondence to Dr Ailsa Russell; a.j.russell{at}bath.ac.uk

Abstract

Introduction High rates of co-occurring depression are reported in autism spectrum disorder (ASD), a neurodevelopmental condition characterised by social communication impairments and repetitive behaviours. Cognitive-behavioural interventions adapted for ASD have been effective for anxiety problems. There have been evaluation studies of group cognitive-behavioural therapy for co-occurring depression, but no randomised trials investigating low-intensity psychological interventions as recommended in clinical guidelines for mild-moderate depression.

Methods and analysis A feasibility study comprising a randomised controlled trial (RCT) and nested qualitative evaluation is under way as preparation for a definitive RCT. Participants (n=70) will be randomised to Guided Self-Help: a low-intensity psychological intervention based on behavioural activation adapted for ASD or treatment as usual. Outcomes including depression symptoms, anxiety, social function and service use will be measured at 10, 16 and 24 weeks postrandomisation and will be blind to group allocation for measures that are not self-administered. The analysis will aim to establish the rates of recruitment and retention for a larger-scale RCT as well as the most appropriate measure of depression to serve as primary outcome. The qualitative study will purposively sample up to 24 participants from each treatment group to consider the acceptability and feasibility of the intervention and the trial design.

Ethics and dissemination Ethical approval has been received from WALES REC 3 (IRAS project ID: 191558) and the Health Research Authority with R&D approval from Avon and Wiltshire Mental Health Partnership and Northumberland, Tyne and Wear Foundation NHS Trusts. To our knowledge, this is the first study of a low-intensity intervention for depression in adults with autism. The results will inform the design of a definitive RCT. Dissemination will include peer-reviewed journal publications reporting the quantitative and qualitative research findings of the study and presentations at national and international conferences.

Trial registration number ISRCTN54650760; Pre-results.

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors All authors contributed to the development of the study protocol. AR, SB and KC developedthe intervention, NW provided methodological and statistical expertise in trialdesign, JH designed the qualitative evaluation, DG and CM developed thestatistical analysis plan.

  • Funding This project was funded by the Health Technology Assessment programme (HTA 14/43/02). This study was also supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol.

  • Competing interests KC, IE, DG, JH, DK, JP, DR and AR have nothing to disclose; SB reports grants from NIHR, during the conduct of the study; CM reports grants from UK National Institute of Health Research HTA programme, during the conduct of the study; BI is a consultant clinical psychologist employed by an NHS Trust which has received external funding (NIHR and charities) to support his involvement in adult autism research projects; NW reports grants from University of Bristol, during the conduct of the study.

  • Patient consent Obtained.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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