Title: A randomised controlled trial to investigate the clinical effectiveness and cost-effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies
Funder: Department of Health and Social Care

Abstract: Research question The proposed research will investigate whether Mindfulness-Based Cognitive Therapy (MBCT), a group-based treatment combining intensive training in mindfulness meditation and cognitive therapy, can effectively reduce symptoms and lead to sustained recovery in patients suffering from Major Depressive Disorder who have not sufficiently responded to high-intensity evidence-based therapy and have thus come to the end of the Increasing Access to Psychological Therapies (IAPT) care pathway. It will also test whether the introduction of this treatment can reduce subsequent service use. Background If not treated sufficiently, Major Depression tends to take a recurrent or chronic lifetime course that is associated with a significantly increased risk for physical and neurodegenerative disorders. IAPT services provide evidence-based treatment for patients with common mental disorder with an access rate intended to rise to 25% of this population by 2021. However, about 50% of the depressed patients who come to the end of this pathway, have not responded sufficiently. MBCT has previously been shown to be effective in treatment non-responders and further evidence from a definitive trial would provide the necessary evidence to enable its implementation for this purpose within the IAPT pathway. Aims and Objectives The aims of this research are to establish (a) the clinical effectiveness in terms of reductions in depressive symptomatology and (b) the cost-effectiveness and implementability of MBCT as a psychotherapeutic treatment option compared with treatment-as-usual (TAU) for depressed patients who have not responded sufficiently to high-intensity evidence-based treatments within the IAPT pathway. Our objectives are (a) to undertake a definitive randomised controlled trial (RCT) of the MBCT intervention versus TAU to confirm clinical effectiveness of the treatment in depressed non-responders to high-intensity evidence-based treatments within the IAPT care pathway, and (b) to use the data from the RCT to conduct a cost-utility and cost-effectiveness analysis to provide information on whether or not the MBCT intervention is worthwhile economically. Methods We will randomly allocate 234 patients who have not sufficiently responded to IAPT high-intensity therapy to take part either in MBCT or to continue with TAU in a three-centre (London, Exeter, Sussex) RCT. Reductions in depression symptomatology will be assessed using the Patient Health Questionnaire-9, a standard measure of the severity of depression used in IAPT treatment-monitoring, at 10-week (secondary outcome) and 34-week follow-up post-randomisation (primary outcome). Service-use information will be collected using the Adults Service Use Schedule. Timelines for delivery In each site, we will recruit 3 cohorts of 26 participants with an initial recruitment phase of 3 months and at least 1-month intervals between treatment phases. Anticipated total duration is 24 months including 3 months for set-up, 7 months for final follow-up and assessment of the last cohort, and 4 months for data analysis and write-up. Anticipated impact and dissemination If successful, the current project would provide the necessary evidence base for the introduction of MBCT for IAPT high-intensity non-responders. Implementation would build on a national training initiative for IAPT practitioners led by our centres and complement dissemination to all stakeholders using publications, presentations, social media, and workshops.

Lay abstract: Aim of the research The aim of our research is to test whether Mindfulness-Based Cognitive Therapy (MBCT), a treatment using training in meditation to help people deal with negative mood, can reduce symptoms of depression in patients who previously received talking therapy, but did not improve. We would also like to see whether MBCT could be introduced at a reasonable cost. Background Depression is a common problem. When treated well, it can resolve completely. When it doesn t, there is an increased risk of developing long-term or recurrent symptoms. Within the National Health Service (NHS), talking therapies are available through the Increasing Access to Psychological Therapies (IAPT) initiative. We know that only half of the patients treated through IAPT fully recover by the end of their treatment. Of these, only those considered at serious risk are offered other treatments, a group of less than 1 in 10 of the people who haven t improved. There is evidence that MBCT can help people with depression who have not found other approaches helpful. If our study shows that MBCT benefits people who haven t improved after IAPT, it will justify its use in this context in the NHS - to help more patients with depression recover. Design and methods We will recruit 234 patients who have received all that IAPT can offer and have not significantly improved. Patients will be chosen by chance to either participate in MBCT or continue with what would be their usual care. We will assess changes in patients symptoms directly after the end of the treatment and 6 months thereafter. This will allow us to look at immediate effects of the treatments, and whether benefits are maintained over time. We will also gather information on patients use of health services in order to see whether, and to what degree, MBCT delivers value for money and interview people who received MBCT to explore their views about it. Patient and public involvement We talked to many people who have had MBCT and found great enthusiasm to support its use more widely. People with depression, including some who have experience of MBCT, have been involved at every stage of the application, helping us design the study. They are an integral part of our research team. Dissemination If successful, our study would enable the NHS to address an important gap in the national IAPT services. In order to help them with this, we would train IAPT therapists to deliver MBCT for those who have not fully recovered. Results of the study will be shared with patients and their families, carers, health professionals, other researchers, and the general public through publications, presentations, social media, and workshops.

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