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
Language English Country Great Britain, England Media electronic
Document type Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't
Grant support
Department of Health - United Kingdom
PubMed
35732378
PubMed Central
PMC9226877
DOI
10.1136/bmjopen-2021-056355
PII: bmjopen-2021-056355
Knihovny.cz E-resources
- Keywords
- anxiety disorders, depression & mood disorders, primary care, schizophrenia & psychotic disorders,
- MeSH
- Health Services Accessibility MeSH
- Mental Disorders * therapy MeSH
- Cognitive Behavioral Therapy * methods MeSH
- Humans MeSH
- Primary Health Care MeSH
- Psychotic Disorders * therapy MeSH
- Randomized Controlled Trials as Topic MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Clinical Trial Protocol MeSH
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.
Cambridgeshire and Peterborough NHS Foundation Trust Cambridge Cambridgeshire UK
Cambridgeshire and Peterborough NHS Foundation Trust Fulbourn Cambridgeshire UK
Centre for the Economics of Mental and Physical Health King's College London London UK
Health Sciences University of York York UK
Kinanthropology Charles University Prague Czechia
Manchester Metropolitan University Manchester Greater Manchester UK
Medicine Universidad de Salamanca IBSAL Salamanca Castilla y León Spain
Norfolk and Suffolk NHS Foundation Trust Norwich Norfolk UK
Norwich Medical School University of East Anglia Norwich Norfolk UK
Psychiatry University of Cambridge Cambridge Cambridgeshire UK
Psychology University of Oxford Oxford UK
Psychology University of Sussex Brighton Brighton and Hove UK
Psychology University of Sussex Brighton UK
Sussex Partnership NHS Foundation Trust Worthing West Sussex UK
The McPin Foundation London Greater London UK
THIS Institute University of Cambridge Primary Care Unit Cambridge Cambridgeshire UK
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ISRCTN
ISRCTN93895792