NIHR Signal Mindfulness therapy may provide an alternative to continuing antidepressants in preventing recurrence of depression

Published on 25 April 2015

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.

Mindfulness therapy may provide an alternative to continuing antidepressants in preventing recurrence of depression

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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.

Citation

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).

 

Bibliography

Evans-Lacko S, Knapp M. Importance of social and cultural factors for attitudes, disclosure and time off work for depression: findings from a seven country European study on depression in the workplace. PloS one. 2014;9(3):e91053.

Hunot V, Moore TH, Caldwell DM, Furukawa TA, Davies P, Jones H, et al. 'Third wave'cognitive and behavioural therapies versus other psychological therapies for depression. Cochrane Database of Systematic Reviews. 2013;(10):CD008704.

HSCIC. Adult psychiatric morbidity in England, results of a household survey. Leeds: The Health & Social Care Information Centre; 2009.

IAPT Programme. Improving Access to Psychological Therapies Programme. [internet]. NHS.

NICE. Depression in adults: the treatment and management of depression in adults. CG90. London: National Institute for Health and Care Excellence; 2009.

Piet J, Hougaard E. The effect of mindfulness-based cognitive therapy for prevention of relapse in recurrent major depressive disorder: a systematic review and meta-analysis. Clinical Psychology Review. 2011;31(6):1032-40.

WHO. Disease incidence, prevalence and disability. In: The global burden of disease. Geneva: World Health Organization; 2004, update (2008).

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.

Citation

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).

 

Bibliography

Evans-Lacko S, Knapp M. Importance of social and cultural factors for attitudes, disclosure and time off work for depression: findings from a seven country European study on depression in the workplace. PloS one. 2014;9(3):e91053.

Hunot V, Moore TH, Caldwell DM, Furukawa TA, Davies P, Jones H, et al. 'Third wave'cognitive and behavioural therapies versus other psychological therapies for depression. Cochrane Database of Systematic Reviews. 2013;(10):CD008704.

HSCIC. Adult psychiatric morbidity in England, results of a household survey. Leeds: The Health & Social Care Information Centre; 2009.

IAPT Programme. Improving Access to Psychological Therapies Programme. [internet]. NHS.

NICE. Depression in adults: the treatment and management of depression in adults. CG90. London: National Institute for Health and Care Excellence; 2009.

Piet J, Hougaard E. The effect of mindfulness-based cognitive therapy for prevention of relapse in recurrent major depressive disorder: a systematic review and meta-analysis. Clinical Psychology Review. 2011;31(6):1032-40.

WHO. Disease incidence, prevalence and disability. In: The global burden of disease. Geneva: World Health Organization; 2004, update (2008).

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

Published on 25 April 2015

Kuyken, W.,Hayes, R.,Barrett, B.,Byng, R.,Dalgleish, T.,Kessler, D.,Lewis, G.,Watkins, E.,Brejcha, C.,Cardy, J.,Causley, A.,Cowderoy, S.,Evans, A.,Gradinger, F.,Kaur, S.,Lanham, P.,Morant, N.,Richards, J.,Shah, P.,Sutton, H.,Vicary, R.,Weaver, A.,Wilks, J.,Williams, M.,Taylor, R. S.,Byford, S.

Lancet , 2015

BACKGROUND: Individuals with a history of recurrent depression have a high risk of repeated depressive relapse or recurrence. Maintenance antidepressants for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to medication. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce risk of relapse or recurrence compared with usual care, but has not yet been compared with maintenance antidepressant treatment in a definitive trial. We aimed to see whether MBCT with support to taper or discontinue antidepressant treatment (MBCT-TS) was superior to maintenance antidepressants for prevention of depressive relapse or recurrence over 24 months. METHODS: In this single-blind, parallel, group randomised controlled trial (PREVENT), we recruited adult patients with three or more previous major depressive episodes and on a therapeutic dose of maintenance antidepressants, from primary care general practices in urban and rural settings in the UK. Participants were randomly assigned to either MBCT-TS or maintenance antidepressants (in a 1:1 ratio) with a computer-generated random number sequence with stratification by centre and symptomatic status. Participants were aware of treatment allocation and research assessors were masked to treatment allocation. The primary outcome was time to relapse or recurrence of depression, with patients followed up at five separate intervals during the 24-month study period. The primary analysis was based on the principle of intention to treat. The trial is registered with Current Controlled Trials, ISRCTN26666654. FINDINGS: Between March 23, 2010, and Oct 21, 2011, we assessed 2188 participants for eligibility and recruited 424 patients from 95 general practices. 212 patients were randomly assigned to MBCT-TS and 212 to maintenance antidepressants. The time to relapse or recurrence of depression did not differ between MBCT-TS and maintenance antidepressants over 24 months (hazard ratio 0.89, 95% CI 0.67-1.18; p=0.43), nor did the number of serious adverse events. Five adverse events were reported, including two deaths, in each of the MBCT-TS and maintenance antidepressants groups. No adverse events were attributable to the interventions or the trial. INTERPRETATION: We found no evidence that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence. Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence, residual depressive symptoms, and quality of life. FUNDING: National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, and NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula.

The mindfulness-based cognitive therapy programme in the PREVENT trial was delivered by a therapist using a manual-led approach. The group-based skills training programmes were designed to enable patients to learn skills that prevent the recurrence of depression. The programme is a combination of a mindfulness-based stress reduction programme, with proven efficacy in reducing distress in people with chronic disease, and cognitive-behavioural therapy for acute depression, which has shown efficacy in prevention of depressive relapse or recurrence. Participants are helped to learn to become more aware of their bodily sensations, thoughts, and feelings associated with depressive relapse or recurrence and relate to these experiences. Participants learnt mindfulness practices and cognitive-behavioural skills both during sessions and through homework assignments.

Commentary

There is considerable concern about increasing long-term antidepressant use. GPs prescribe antidepressants to 11% of adults, and perhaps half could stop without relapsing, but need help. Kuyken and colleagues’ MBCT helped 70% of participants stop antidepressants, without increasing relapse, so this is an important study. The therapy is intensive however and the skills required in short supply. Group treatment could be provided through the IAPT programme, but many services are already stretched. The study was limited to patients in equipoise over psychological versus antidepressant treatment, which may not apply to many fearful of relapse, and many will prefer individual rather than group treatment.

Professor Tony Kendrick, Professor of Primary Care in Medicine, University of Southampton