Title: A Randomised Controlled Feasibility Trial of a Novel Transdiagnostic Psychological Intervention for Mood and Anxiety Disorders
Funder: Department of Health and Social Care

Abstract: Background Mood and anxiety disorders are among the largest causes of disability in the U.K, affecting 17-20% of individuals at an annual estimated cost of &pound;16.4bn. Psychological treatments (predominantly Cognitive Behaviour Therapy [CBT]) have demonstrable efficacy in treating these conditions and are recommended by NICE. However, even the best such treatments on average only achieve clinical recovery for around 50% of patients and relapse/recurrence is high. The patients who respond least well are those with co-morbid and complex presentations. As 12-month rates of co-morbidity across mood and anxiety disorders can be as high as 40-80%, maximising our ability to effectively treat comorbid and complex mood and anxiety disorders is a priority. Existing evidence-based psychological treatments tend to focus on single diagnoses; e.g., CBT for Panic Disorder, Behavioural Activation for Depression. They are therefore less efficacious for comorbid and complex patients whose difficulties do not fit within the boundaries of a single diagnosis. We have therefore developed a new psychological intervention targeting the range of adult mood and anxiety disorders. This intervention (the Modular Protocol for Mental Health: MP:MH) focuses on underlying emotional, behavioural and cognitive problems that cut across traditional diagnostic boundaries, rather than on symptoms pertaining to any single diagnosis. MP:MH is also a modular intervention (comprising 10 modules), allowing for standardised, yet flexible, treatment delivery, personalised to the problems and goals of the patient. MP:MH potentially provides a powerful treatment option for all adults suffering mood and anxiety disorders. However, the transdiagnostic and modular nature of MP:MH means it is particularly suited to those with complex, comorbid problems, providing superior goodness-of-fit relative to single-diagnosis-led interventions. Aims We are preparing for a fully-powered efficacy trial to evaluate MP:MH for complex and comorbid clients within NHS Secondary Care. The current proposal comprises a scaled-down feasibility trial to evaluate the viability of this later-phase efficacy trial. Our aims are: 1) To evaluate core procedural uncertainties regarding the later-stage trial (recruitment, clinician/patient engagement, measures, trial management). 2) To finalise decisions about the design and powering of the efficacy trial. 3) To explore the feasibility of evaluating cost-effectiveness alongside the efficacy trial. 4) To identify potential key moderators and mediators of MP:MH s effects and the feasibility of measuring these within the later-phase trial. Plan of investigation Participants recruited from local secondary care with a principal diagnosis of a mood or anxiety disorder and at least one comorbid diagnosis will be randomised to Secondary-Care-As-Usual (SCAU) or MP-MH in a 2-arm patient-level feasibility Randomised Controlled Trial (25 participants/arm). SCAU will be whatever psychological and other treatments secondary care clinicians feel are required, with detailed monitoring of what each patient receives. Quantitative outcomes will be recovery from primary/comorbid diagnoses, self-report measures of symptom severity, and assessments of daily functioning, client satisfaction and quality-of-life, administered at baseline, treatment-end, and three-months follow-up. Process measures (Aim 4) indexing candidate mechanisms of change will be administered at the same time points, and before and after relevant modules. Qualitative measures (MP-MH only) will include service-user, manager and clinician views of the feasibility, acceptability and lived experience of the intervention (via semi-structured interview and focus groups). We will also acquire data on economic costs and benefits of MPMH (Aim 3). Potential benefits MP:MH has strong potential to improve treatment efficacy for adult mood and anxiety disorders, especially for clients with complex and comorbid conditions, because it enables flexible goodness-of-fit matching of treatment to those specific vulnerabilities and processes relevant to the individual. Given the tremendous health and social burden of these mental health conditions within the UK, MP:MH has significant capacity to benefit patients and the NHS.

Lay abstract: Anxiety and mood disorders are common conditions affecting up to 20% of adults. These conditions take different forms (or diagnoses) such as Agoraphobia, Panic Disorder, Depressive Disorder, Social Anxiety Disorder, and so on. Currently, our best non-drug (psychological) treatments only focus on individual diagnoses. So, there are separate treatments for Panic Disorder, or Depressive Disorder, or Social Anxiety, etc. These 'diagnosis-specific' treatments work well for people whose problems fit neatly into a single diagnosis. However, they work far less well for people with complex problems involving multiple diagnoses; e.g., someone who is depressed and socially anxious and suffering panic attacks. In fact, 50% of patients fail to repond well to these existing treatments. We have therefore developed a new psychological treatment for anxiety and mood problems (the Modular Protocol for Mental Health [MP:MH]). Instead of focusing on any single diagnosis, MP:MH combines the best treatment techniques into 10 modules (with clinician instructions and materials for service-users) each of which targets problems common across all of the different mood and anxiety diagnoses (e.g., intense emotions, negative thinking, upsetting memories, distressing habits). MP:MH should therefore be a better treatment for the large numbers of individuals whose problems do not fit neatly into a single diagnosis and for whom any treatments targeting a single diagnosis would leave significant difficulties unaddressed. We have tested MP:MH on a series of people ('cases'), each with a complex mixture of anxiety and mood disorders, with promising results. We are now preparing for a large clinical trial to discover how well MP:MH works for these more complex cases, compared to the standard treatment people receive in NHS Secondary Care. In this proposal we are seeking funding for a much smaller trial (called a feasibility trial) to check that this planned larger trial can be done successfully.

Research activity codes: 5.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH