Treating common mental disorder including psychotic experiences in the primary care improving access to psychological therapies programme (the TYPPEX study): protocol for a stepped wedge cluster randomised controlled trial with nested economic and process evaluation of a training package for therapists
David Fowler,
Jesus Perez,
Peter B Jones,
Debra Russo,
Clare Knight,
Mary Dixon-Woods,
Allan B Clark,
Margaret Heslin,
Sarah Byford,
Paul French,
Thomas Kabir,
Jan Stochl,
Mona Kanaan,
James Clarke,
Nick Grey,
Ann Marie Swart,
Polly-Anna Ashford,
Ushma Patel,
Freya Stuart,
Hannah Murray,
J Hodgekins,
Nesta Reeve,
Nicola Marshall,
Michelle Painter,
Maria Leathersich,
Martin Pond
Affiliations
David Fowler
Psychology, University of Sussex, Brighton, UK
Jesus Perez
Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, Cambridgeshire, UK
Peter B Jones
NIHR Applied Research Collaboration (ARC) East of England (EoE), Cambridge, UK
Debra Russo
Psychiatry, University of Cambridge, Cambridge, Cambridgeshire, UK
Clare Knight
Psychiatry, University of Cambridge, Cambridge, Cambridgeshire, UK
Mary Dixon-Woods
1 Department of Public Health and Primary Care, THIS Institute (The Healthcare Improvement Studies Institute), University of Cambridge, Strangeways Research Laboratory, Cambridge, UK
Allan B Clark
1 Norwich Medical School, University of East Anglia, Norwich, UK
Margaret Heslin
Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK
Sarah Byford
King`s College London, London, UK
Paul French
3 Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, UK
Thomas Kabir
The McPin Foundation, London, Greater London, UK
Jan Stochl
Department of Psychiatry, University of Cambridge, Cambridge, UK
Mona Kanaan
Department of Health Sciences, University of York, York, UK
James Clarke
2 La Jolla Institute for Immunology, La Jolla, California, USA
Nick Grey
Psychology, University of Sussex, Brighton, Brighton and Hove, UK
Ann Marie Swart
Norwich Medical School, University of East Anglia, Norwich, Norfolk, UK
Polly-Anna Ashford
Norwich Medical School, University of East Anglia, Norwich, UK
Ushma Patel
Cambridgeshire and Peterborough NHS Foundation Trust, Fulbourn, Cambridgeshire, UK
Freya Stuart
Psychiatry, University of Cambridge, Cambridge, Cambridgeshire, UK
Hannah Murray
Psychology, University of Oxford, Oxford, UK
J Hodgekins
Norwich Medical School, University of East Anglia, Norwich, Norfolk, UK
Nesta Reeve
Norfolk and Suffolk NHS Foundation Trust, Norwich, Norfolk, UK
Nicola Marshall
Cambridgeshire and Peterborough NHS Foundation Trust, Fulbourn, Cambridgeshire, UK
Michelle Painter
Norfolk and Suffolk NHS Foundation Trust, Norwich, Norfolk, UK
Maria Leathersich
Norwich Medical School, University of East Anglia, Norwich, Norfolk, UK
Martin Pond
Norwich Medical School, University of East Anglia, Norwich, Norfolk, UK
Introduction At least one in four people treated by the primary care improving access to psychological therapies (IAPT) programme in England experiences distressing psychotic experiences (PE) in addition to common mental disorder (CMD). These individuals are less likely to achieve recovery. IAPT services do not routinely screen for nor offer specific treatments for CMD including PE. The Tailoring evidence-based psychological therapY for People with common mental disorder including Psychotic EXperiences study will evaluate the clinical and cost-effectiveness of an enhanced training for cognitive behavioural therapists that aims to address this clinical gap.Methods and analysis This is a multisite, stepped-wedge cluster randomised controlled trial. The setting will be IAPT services within three mental health trusts. The participants will be (1) 56–80 qualified IAPT cognitive behavioural therapists and (2) 600 service users who are triaged as appropriate for cognitive behavioural therapy in an IAPT service and have PE according to the Community Assessment of Psychic Experiences—Positive 15-items Scale. IAPT therapists will be grouped into eight study clusters subsequently randomised to the control-intervention sequence. We will obtain pseudonymous clinical outcome data from IAPT clinical records for eligible service users. We will invite service users to complete health economic measures at baseline, 3, 6, 9 and 12-month follow-up. The primary outcome will be the proportion of patients with common mental disorder psychotic experiences who have recovered by the end of treatment as measured by the official IAPT measure for recovery.Ethics and dissemination The study received the following approvals: South Central—Berkshire Research Ethics Committee on 28 April 2020 (REC reference 20/SC/0135) and Health Research Authority (HRA) on 23 June 2020. An amendment was approved by the Ethics Committee on 01 October 2020 and HRA on 27 October 2020. Results will be made available to patients and the public, the funders, stakeholders in the IAPT services and other researchers.Trial registration number ISRCTN93895792.
