Award Title: Tailoring evidence-based psychological therapY for People with common mental disorder including Psychotic EXperiences (TYPPEX)
Funder: Department of Health and Social Care

Abstract: Aims and objectives   We aim to improve the prospects of recovery for people with common mental disorder including psychotic experiences attending Improving Access to Psychological Therapies (IAPT) services (http://www.iapt.nhs.uk/).   Working with our service-user advisory group, our objectives are to:    Explore attitudes in IAPT settings towards identification and treatment of people with psychotic experiences; introduce a simple tool to identify them; and measure their outcomes. Tailor evidence-based psychological therapy (TYPPEX) for these people, and develop effective training for higher-tier IAPT therapists. Implement a stepped-wedge cluster-randomised controlled trial (cRCT) of TYPPEX. Define best practice in policy and commissioning regarding care pathways for people with psychotic experiences and ensure its adoption and diffusion. Establish a blueprint for evaluating further innovations in therapies deployed in IAPT.    Background and rationale   Psychotic experiences are common, often indexing the severity of underlying common mental disorder; only rarely do they indicate incipient psychotic illness. People with common mental disorder including psychotic experiences are poorly served by mental health services, and would prefer to be helped in primary care or IAPT services. Our preparatory work in IAPT services has shown that psychotic experiences are not routinely measured in IAPT services but are common in the people they serve. In addition,  psychotic experiences were associated with poor response to conventional IAPT psychological therapies. The lack of effective therapies allows psychopathology and disability to evolve, negating recovery.   Research plan   We propose five workpackages implemented across 12 separate IAPT teams provided by large IAPT services (provider sites) in Cambridgeshire and Peterborough, Norfolk and Suffolk, and Sussex.  We shall:    Explore service-users , IAPT therapists  and managers  views on the identification and treatment of people with “common mental disorder including psychotic experiences” in IAPT services; and conduct a systematic review of psychological therapies for these phenomena. Tailor evidence-based psychological therapY for People with common mental disorder including Psychotic EXperiences (TYPPEX), and develop a training package regarding TYPPEX for IAPT therapists. Determine the prevalence of common mental disorder including psychotic experiences in the higher-tier of IAPT services; establish the response to current treatments; and confirm effectiveness and sample size prior to a stepped-wedge cRCT of TYPPEX. Implement a stepped-wedge cRCT of TYPPEX in the higher-tier of IAPT services. This will also demonstrate a means of evaluating other treatment innovations in IAPT settings.    We shall test the hypothesis that TYPPEX is more effective and cost-effective than treatment-as-usual. We shall randomise training in TYPPEX to IAPT teams with ~15 higher-tier IAPT therapists each, measuring patient-reported outcomes within the service-users seen by therapists before and after training.   Inclusion criteria for service-users will be age ≥16 years, consenting to additional assessment and possible allocation to a trained higher-tier IAPT therapist, and presence of psychotic experiences. The only exclusion criterion will be mental disorder meriting referral to secondary care (usual IAPT practice). Accordingly, we estimate that at least 2,700 service-users would agree to take part over 20 months of recruitment. Each IAPT therapist will treat at least three at any one time.   The primary outcome will be "Reliable Recovery" based on the routine IAPT patient-reported outcomes (http://www.iapt.nhs.uk/silo/files/measuring-recovery-2014.pdf/). We shall analyse it at the beginning and end of treatment (last therapy session), and one year after treatment initiation. The primary effectiveness end-point will be obtained at the last therapy session, as per routine practice. In our preparatory work, Reliable Recovery prevalence for service-users with psychotic experiences  was 39%, versus 62% for those without them (p=0.008).   A stepped wedge design with five steps of 4 months (including a baseline step with all therapists in the control arm) with 2 IAPT teams (clusters) randomised at each step and each team having 5 therapists each seeing 3 service-users per step would have just over 80% power to detect a Reliable Recovery difference in the arms of 0.39 and 0.58 (50% increase) at the 5% level of significance, assuming an intra-cluster correlation of 0.05. This would involve a total of 600 service-users and 8 teams. In order to allow for drop-out and flexibility, the aim is to recruit 10 therapists from each team; this would involve 1200 service-users and 80 therapists.   Intention-to-treat analyses will compare Reliable Recovery proportions between service-users treated by therapists before and after training in TYPPEX. We will also conduct economic evaluations.   Projected outputs & dissemination plans   We shall produce a new tailored therapy to treat people with common mental disorder including psychotic experiences and a training package for higher-tier IAPT therapists. Advised by our service-user group, and exploiting strong partnerships with NIHR CLAHRCs and an established co-production approach with stakeholders, our implementation plans (workpackage 5) run throughout the programme.   Benefits to patients and the NHS   Our programme aims to increase recovery for people with common mental disorder including psychotic experiences in high-volume IAPT services. Increasing the efficiency of these services underpins wider provision of cost-effective NHS mental health care.

Lay Abstract: The TYPPEX study (Tailoring evidence-based psychological therapY for People with common mental disorder including Psychotic EXperiences).   Too many people with common mental health problems, such as depression or anxiety, do not recover after receiving talking therapy. People usually receive cognitive behavioural therapy (CBT), delivered by Improving Access to Psychological Therapy (IAPT) also called Psychological Wellbeing services. Some people who do not get better are experiencing more severe forms of common mental health problems including psychotic experiences such as paranoia or hearing voices.     About one-in-five people using higher-intensity IAPT services have some psychotic experiences, often after traumatic events. Currently, IAPT services do not support these people particularly well. In some cases, they are referred to specialist  early intervention  in psychosis services. These specialist services tend to focus on psychotic experiences and the risk of people developing more severe mental health conditions such as schizophrenia. This is despite the fact that the vast majority of people who have psychotic experiences do not develop schizophrenia. In addition, such services do not usually address the depression, anxiety, and other problems that affect this group of people.     For people experiencing a common mental health disorder as well as psychotic experiences, neither IAPT services nor early intervention services fully meet their needs. One of our service-user advisors said, “It was like being stranded in no-man s-land…there was simply no service that was right for me”. The TYPPEX study will develop a form of talking therapy that will meet the needs of people with a common mental health condition and psychotic experiences. This talking therapy will be offered to service-users in IAPT settings, making it more accessible and less stigmatising than specialist mental health services.     We will use a brief questionnaire to help identify people using IAPT services with psychotic experiences. We will use the best research evidence, and the views from service-users and IAPT therapists to design a new therapy for these people. IAPT therapists will then be trained to deliver the new therapy using a specially developed training package. We will then prepare for a large study to test how well this new therapy works. It is possible that the training of therapists will improve with experience. Therefore, the study randomly selects the order that teams of IAPT therapists were trained in the new therapy. We will then check if this therapy helps service-users with psychotic experiences better than standard therapy by comparing how many of them recover before and after the new therapy is introduced, team-by-team.     This work should help service-users. It will also support IAPT services to achieve their challenging performance targets, and provide a blueprint for testing other therapies beyond current CBT.

Research Activity Codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health Categories: MENTAL HEALTH