This NIHR-funded RCT found no evidence that mindfulness-based cognitive therapy was better than continuing antidepressant drugs in reducing depression relapse or recurrence for people at the highest risk of depression. There was also no significant difference in cost.
When interpreted alongside the broader evidence for mindfulness-based cognitive therapy and the need for patient choice, the findings suggest an alternative for those patients wishing to consider an alternative to maintenance anti-depressants, and reinforce NICE guidance. However, service limitations may be a barrier to implementation.
Why was this study needed?
Depression imposes a large burden on individuals, families and society, in terms of poor quality of life and lost productivity. Depression relapse or recurrence is common in people with three or more previous episodes of depression, with 80% of people becoming ill again without treatment over two years.
While antidepressants are effective at reducing the rate of relapse or recurrence, many people are interested in alternatives to medication. A 2011 systematic review showed that mindfulness-based cognitive therapy reduced rates of relapse by 34% compared with usual care or placebo. However, there was relatively little evidence of its effectiveness compared with antidepressants. The NIHR funded this study to compare group-delivered, mindfulness-based cognitive therapy and support to taper and discontinue medication (MBCT-TS) with the usual practice of continuing antidepressant medication.
What did this study do?
This large randomised controlled trial (PREVENT) recruited 424 people from general practices in the west of England. It was a superiority trial, meaning that researchers aimed to show that mindfulness (and tailing off antidepressants) was better than continuing antidepressants for people happy to try either strategy. Participants had already experienced three or more episodes of depression and were on antidepressant medication. Half the participants were randomised to continue their antidepressant medication, and the other half to eight sessions of MBCT‑TS plus an optional four refresher sessions. The trial was well conducted and sufficiently large, and the results should be reliable.
What did it find?
- There was no evidence that mindfulness-based cognitive therapy and support to taper and discontinue medication was superior to the usual practice of continuing medication on the primary outcome of depressive relapse and recurrence. There was no significant difference in any of the predetermined secondary outcomes.
- 44% of people in the MBCT-TS group and 47% in the antidepressant group experienced relapse or recurrence (hazard ratio 0.89, 95% confidence interval 0.67 to 1.18).
- Treatment costs were similar: £112 for each MBCT-TS participant and £124 for each participant on maintenance medication.
- Adherence to treatment in both arms was good and similar: 83% of the MBCT-TS participants completed four or more sessions, and 76% of the maintenance antidepressants group remained on the therapeutic dose of their medication.
What does current guidance say on this issue?
The 2009 NICE guideline on the treatment and management of depression in adults recommends that people who have experienced at least three or more previous episodes of depression and are currently well, should be offered MBCT. Ideally this should be delivered in groups of 8 to 15 participants and consist of weekly 2-hour meetings over 8 weeks and four follow-up sessions in the 12 months after the end of treatment. The guideline is due to be updated in 2017.
What are the implications?
Mindfulness-based cognitive therapy and maintenance antidepressants resulted in similar outcomes and cost. This, taken together with the wider research and clinical context of offering patient choice, supports MBCT-TS as an alternative treatment for those people wishing to stop antidepressant medication earlier than the recommended two years of treatment. Clinical decisions around tapering and discontinuation need to be taken collaboratively and thoughtfully with patients and their GPs.
The challenge for the NHS is finding the resource to offer such a service. The NHS Improving Access to Psychological Therapies (IAPT) programme was introduced in 2008 to address unmet high need for psychological treatments for people with depression and anxiety disorders. MCBT service could be delivered through the programme. However, demand for IAPT services is already high and there are as yet few adequately trained MBCT therapists working in IAPT services.
Finally, further evidence is needed to find out what patients prefer and which patients might benefit most from MBCT. A subgroup analysis in the present trial suggested that MBCT may particularly benefit those who have experienced childhood abuse. More research will be needed to verify this.
Kuyken W, Hayes R, Barrett B, et al. Effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse or recurrence (PREVENT): a randomised controlled trial. The Lancet. 2015 (Online first).
The full report and economic evaluation is available at: http://www.journalslibrary.nihr.ac.uk/hta/volume-19/issue-73
This project was funded by the National Institute for Health Research HTA Programme (project number 08/56/01).
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Produced by the University of Southampton and Bazian on behalf of NIHR through the NIHR Dissemination Centre