Title: Low-intensity guided help through mindfulness (LIGHTMind): A randomised controlled trial comparing supported Mindfulness-Based Cognitive Therapy self-help to supported Cognitive Behaviour Therapy self-help for adults experiencing depression
Funder: Department of Health and Social Care

Abstract: Background to the Research Around 15% of adults in England experience clinically significant depression or anxiety in any week6. Improving Access to Psychological Therapies (IAPT) is an NHS initiative launched in 2006 that aims to improve access to psychological therapies for people experiencing anxiety and depression with around 1 million people now referred to IAPT each year7. The majority of people (55%) referred to IAPT experience some form of depression8. Depression is typically recurrent - following one episode of major depression 50% will relapse and after two episodes 80% relapse9. In order to meet the needs of people experiencing depression IAPT offer supported cognitive behaviour therapy (CBT) self-help in the first instance for people experiencing mild or moderate symptoms. However, IAPT have shown disappointing treatment outcomes for CBT self-help - only around 40%8 of people completing treatment for depression meet criteria for remission. A related problem in IAPT is high rates of treatment drop-out - only around 40% of IAPT referrals complete a course of treatment7 - completing treatment is important because it is associated with better outcomes10. Therefore, improving remission rates for depression and increasing treatment completion require urgent attention. Mindfulness-based cognitive therapy (MBCT) is a group therapy for depression recommended by NICE11. MBCT self-help (MBCT-SH) in IAPT has the potential to reduce the cost of delivery and to widen access to people unable or unwilling to attend a group12. The potential of MBCT-SH as an clinically- and cost-effective treatment for depression in IAPT is the focus of this study and is the next step in our research programme. Aims of the Work Following our successful pilot work we aim to compare MBCT-SH with CBT-SH for people experiencing mild to moderate depression. Questions to be Addressed Our primary hypothesis is that MBCT-SH, in comparison to CBT-SH, will lead to greater reductions in depressive symptom severity from baseline to post-intervention. Secondary hypotheses include that MBCT-SH, in comparison to CBT-SH, will show greater reductions in generalised anxiety and greater improvements in mindfulness, wellbeing and work and social adjustment at post-intervention and at six-months follow-up. It is also hypothesised that MBCT-SH in comparison to CBT-SH will show greater rates of treatment completion and will be cost-effective. The qualitative component of the study asks: what are the facilitators and barriers to treatment completion for CBT-SH and MBCT-SH? This will address the evidence gap in our understanding of reasons for non-engagement at Step 2. Plan of Investigation 410 people meeting diagnostic criteria for major depressive disorder or mixed anxiety and depression will be randomly allocated to receive MBCT-SH or CBT-SH, along with four sessions of support from a psychological wellbeing practitioner. Participants will complete measures of depression, generalised anxiety, wellbeing, mindfulness and work and social adjustment at baseline, 16 weeks (post-intervention) and 42 weeks (6-months follow-up). Health economic measures will also be completed and 32 participants will be interviewed about their experiences. Potential Benefits to Patients More than 1 million people are referred to IAPT each year, 55% of whom experience some form of depression. If hypotheses are supported, findings from this research can help ensure that such people have access to a novel, effective and low-cost intervention. Potential Benefits to the NHS Depression is estimated to cost the economy in England &pound;12.15 billion a year by 202613 and depression is typically recurrent9. This proposed research has the potential to identify a more effective, low-cost and acceptable intervention for people experiencing mild to moderate depression than is currently available which will enable the NHS to effectively treat more people with depression whilst also reducing the economic burden that is associated with the condition.

Lay abstract: Depression has serious personal, family and economic consequences. It is estimated that depression will cost &pound;12.15 billion to the economy each year in England by 2026. Improving Access to Psychological Therapies (IAPT) is the NHS talking therapies service in England for adults experiencing anxiety or depression. Approximately 1 million people are referred to IAPT every year, over half experiencing depression. Where symptoms of depression are mild/moderate people are typically offered Cognitive Behaviour Therapy (CBT) self-help supported by a psychological wellbeing practitioner (PWP). The problem is that over half of people (58%) who complete treatment for depression in IAPT remain depressed despite receiving the NICE-recommended treatment. Furthermore, less than half (40%) of IAPT clients complete treatment. This study seeks to investigate an alternative to CBT self-help. We believe that mindfulness-based self-help &ndash; which differs from CBT in focus, approach and practice &ndash; would be more effective with lower dropout. We conducted a study with 40 people comparing these two forms of self-help (CBT and Mindfulness). We found people using mindfulness-based self-help showed greater improvement in depression and twice as many people completed mindfulness-based self-help. In this proposed study 410 people experiencing mild-moderate depression will be randomly allocated to using a mindfulness-based self-help workbook or to a CBT-based self-help workbook. Each person will be asked to complete their workbook with 16 weeks and will have four PWP support sessions during this time. The primary outcome we will measure is depression symptom severity. We will also measure treatment completion because evidence shows completing treatment leads to better outcomes. Assessments will be made at the start of the study and then again after 16 weeks and then after a further 6 months and 32 participants will be interviewed about their experiences. Positive findings could lead to mindfulness-based self-help being routinely offered in the NHS.

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