Low-Intensity Guided Help Through MINDfulness (LIGHTMind 2): A randomised controlled trial comparing supported Mindfulness-Based Cognitive Therapy self-help to supported Cognitive Behaviour Therapy self-help for adults experiencing depression

Study ID: 33702
Short Title: LIGHTMind 2: Low-Intensity Guided Help Through MINDfulness
Organisation: Solent NHS Trust
Location: Solent NHS Trust
Condition: Depression
Main Specialty: Mental Health
Expected End Date: 01/09/2019
Postcode: PO3 6AD
Contact Name: R&D department
Contact Email: research@solent.nhs.uk
Active: Yes

Inclusion Criteria

Inclusion criteria are that participants will: (1) be aged 18 years or over; (2) meet diagnostic criteria on the revised Clinical Interview Schedule (CIS-R) for a primary diagnosis of a depressive episode, or mixed anxiety and depression; (3) score 10 or more on the PHQ-9 at their initial IAPT assessment (the cut-off for a major depressive episode); and (4) have sufficient literacy skills to read and understand the self-help materials

Exclusion Criteria

Exclusion criteria are that if people: (1) have severe symptoms of depression (a score 20 or more on the PHQ-9); (2) score of 4 on the CIS-R suicidality scale (3) express a strong preference (5/5) for one intervention over the other on the Treatment Preference Question such that if randomised to the non-preferred intervention they would be likely to drop out of the intervention.

Study summary:

Depression has serious personal, family and economic consequences. It is estimated that depression will cost £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 – which differs from CBT in focus, approach and practice – 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 six 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.

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