Title: Evaluating the feasibility and acceptability of Method of Levels therapy for people experiencing a first episode of psychosis
Funder: Health Education England

Abstract: Title: Evaluating the feasibility and acceptability of Method of Levels therapy for people experiencing a first episode of psychosis. Background: This study will investigate an innovative psychological therapy that has the potential to make a significant positive impact on the care received by people experiencing psychosis, symptoms of which include hallucinations, delusions and disorganised thinking. Psychosis has a profound negative impact on individuals and families, and places an enormous economic burden on society. Objectives: This study aims to evaluate the feasibility and acceptability of Method of Levels (MOL) therapy for people experiencing a first episode of psychosis. MOL is a transdiagnostic psychological therapy that is significantly different from current psychological interventions for people experiencing psychosis and has several potential advantages, including: increased service user control over the interventions they receive; it can be delivered to service users presenting with multiple and diverse problems (which means clinicians do not require training for multiple, disorder-specific models); and it directly targets the underlying core processes that maintain psychological distress. Research Questions: Is MOL an acceptable psychological intervention for people experiencing a first episode of psychosis? Is it feasible to deliver MOL to people experiencing a first episode of psychosis? Are any adaptations required for MOL to effectively meet the psychological needs of this population? Research Plan: There are three interrelated phases to the proposed research, designed to answer the study's research questions. Phase 1: Narrative review of the literature relating to psychological interventions for people experiencing a first episode of psychosis, including any literature relating to their feasibility and acceptability, and the development of novel psychological interventions for this group. This review will survey and critically analyse research in this area, place the current research in the context of previous research, highlight gaps in knowledge that the current research project can answer, and inform the development of phases 2 and 3. Phase 2: Pilot randomised controlled trial of MOL for people experiencing a first episode of psychosis. Objective: Although some clinical data will be gathered using standardised outcome measures, the main focus will be on the recruitment and retention of participants within the study. This will be used to determine whether it is feasible to recruit for a larger definitive study of MOL for first episode psychosis. Participants: The intention is to recruit 30 participants from Early Intervention Services within the host organisation. Method: Participants will be randomised to receive either MOL plus treatment as usual (TAU), or TAU alone. Participants in the MOL plus TAU group will receive 16 sessions of MOL over 6 months Outcome measures: The primary outcome will be the extent that it proves possible to recruit and retain participants in the study. Analysis: The primary analysis will involve tabulated and associated graphical summaries of the recruitment and retention into the study. To inform potential effect sizes for a future definitive trial we will use linear regression to examine the effect of random allocation on the outcome measures at post-treatment, adjusting for outcome measures at baseline. Phase 3: Qualitative investigation into the user experience of receiving MOL. All participants from Phase 2 will be invited to participate in a qualitative interview about their experience of the therapy. These interviews will be conducted and analysed using thematic analysis. This phase is designed to answer the research questions about the acceptability of MOL and whether any adaptations are required for it to effectively meet the needs of this population. Outcomes: This study will determine the suitability of MOL for further investigation and answer the question of whether it is feasible to conduct a definitive trial of MOL for psychosis.

Lay abstract: This research investigates the use of a talking therapy called Method of Levels' (MOL) for people experiencing a first episode of psychosis, which is where people lose touch with reality in some way. For example, seeing or hearing things others cannot (hallucinations) or holding beliefs others find unusual (delusions). Psychosis is distressing for individuals and families, and is very costly for society in economic terms. Early intervention (EI) teams were established to help people experiencing a first episode of psychosis work towards recovery. They deliver treatments such as antispychotic medication and a talking therapy known as cognitive behavioural therapy' (CBT). Antipsychotics and CBT are helpful for some people, but not all. Many people continue to experience distressing symptoms of psychosis despite being treated with antipsychotics. Similarly, CBT is beneficial for some people but not others, and many people struggle to access CBT or find it hard to engage with. Method of Levels (MOL) therapy is a transdiagnostic' approach, which means it targets any problem identified by the client, regardless of the diagnosis they have been given. This is particularly useful because psychosis occurs across a wide range of diagnoses. Also, people experiencing psychosis often meet diagnostic criteria for multiple disorders at the same time, including anxiety and mood disodered, and personality disorders. Therapists, therefore, are required to work with multiple problems simultaneously. MOL is based on a robust scientific theory, of which a fundamental principle is that people experience distress when they are unable to reach important life goals. This often occurs when they are working towards two or more incompatible or conflicting goals at the same time. Prolonged goal conflict is the most common cause of distress underlying symptoms associated with mental heath difficulties. Typically, MOL therapy involves asking the client a series of questions to help them focus on the problem and broaden their awareness of associated goals and conflict, and balance competing goals. The principles of MOL remain the same whatever the diagnosis. There is evidence already that MOL is helpful for a wide range of problems and has potential advantages over existing treatments for people experiencing a first episode of psychosis, inlcluding: Applicable to service users presenting with diverse and multiple problems. Greater service user involvement, choice and control over the delivery of psychological interventions, duration of therapy, and scheduling of appointments.The potential for it to be a more efficient use of psychological resources due to service-user tailored treatment schedules rather than predetermined treatment packages. It directly targets goal conflict, which is what maintains psychological distress. MOL is the application of a robust scientific theory and based on clear principles, which makes training practitioners more straightforward and guides integration into routine clinical practice. We want to find out if it is feasible to recruit people to a study of MOL for first episode psychosis. We also want to know what the experience of receiving MOL was like and if it needs to be adapted in some way. There are three phases to the research. Phase 1 of the project is a review of what is known about developing psychological interventions for first episode psychosis, which will be used to inform phases 2 and 3. Phase 2 is a pilot randomised controlled trial. This is a small scale study to find out if it is feasible to run a larger study in the future. Participants in the study are allocated to a group where they continue to receive treatment as usual from their early intervention team, or a group where people receive their usual treatment plus MOL. We plan to recruit 30 people who will be randomly allocated to one of these groups. Outcomes from these two groups will be compared, but the main thing we want to find out is whether it is feasible to recruit and retain participants in the study. Phase 3 is a qualitative study where we will interview participants who took part in phase 2 to find out what they thought about MOL and whether it needs to be adapted to meet their needs more effectively. CHAR(13) + CHAR(10)People with lived experience of psychosis have been involved in the development of this research proposal nd service user consultants will be used throughout the study. The main findings will be shared in peer-reviewed journals and at relevant conferences. The findings will be used to determine whether it is feasible to run a larger randomised controlled trial that will answer the question of whether MOL is effective for people experiencing a first episode of psychosis.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH