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

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.