Update to the study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment depressive relapse/recurrence: the PREVENT trial
Open accessAbstract
BACKGROUND: Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance anti-depressants (m-ADM) can prevent relapse. However, individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term. A recently developed treatment, mindfulness-based cognitive therapy (MBCT), shows potential as a brief group program for people with recurring depression.This trial asks the policy research question; is MBCT with support to taper/discontinue antidepressant medication (MBCT-TS) superior to m-ADM in terms of: a primary outcome of preventing depressive relapse/recurrence over 24 months; and secondary outcomes of (a) depression free days, (b) residual depressive symptoms, (c) antidepressant medication (ADM) usage, (d) psychiatric and medical co-morbidity, (e) quality of life, and (f) cost effectiveness? An explanatory research question also asks whether an increase in mindfulness skills is the key mechanism of change.The design is a single-blind, parallel randomized controlled trial examining MBCT-TS versus m-ADM with an embedded process study. To answer the main policy research question the proposed trial compares MBCT-TS with m-ADM for patients with recurrent depression. Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care. RESULTS: Depressive relapse/recurrence over two years is the primary outcome variable. Analyses will be conducted following CONSORT standards and overseen by the trial's Data Monitoring and Safety Committee. Initial analyses will be conducted on an intention-to-treat basis, with subsequent analyses being per protocol. The explanatory question will be addressed in two mutually informative ways: quantitative measurement of potential mediating variables pre- and post-treatment and a qualitative study of service users' views and experiences. CONCLUSIONS: If the results of our exploratory trial are extended to this definitive trial, MBCT-TS will be established as an alternative approach to maintenance antidepressants for people with a history of recurrent depression. The process studies will provide evidence about the effective components which can be used to improve MBCT and inform theory as well as other therapeutic approaches. TRIAL REGISTRATION: Trial registered 7 May 2009; ISRCTN26666654.
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We used interaction terms to undertake predefined exploratory subgroup analyses on the primary outcome, across the stratification variables (recruitment centre and baseline depression severity) and reported childhood abuse.
“We used interaction terms to undertake predefi ned exploratory subgroup analyses on the primary outcome, across the stratifi cation variables (recruitment centre and baseline depression severity) and reported childhood abuse.12,32”
From 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 (2015) · cites this paper as [12]
The “Subgroup analysis high versus low childhood adversity” section (page not provided) says the protocol added an analysis of the interaction between childhood abuse and treatment allocation on the primary outcome. It does not describe subgroup analyses by recruitment centre or baseline depression severity, and it specifies a planned analysis rather than reporting that the analyses were performed. (LLM, conf=0.87)
Experimental — accuracy not yet measuredMindfulness-based approaches have been shown to be effective in managing stress, anxiety, depression, and chronic pain.
“mindfulness-based approaches have been shown to be effective in managing conditions such as stress, anxiety, depression, and chronic pain.”
From Exploring patient experiences with a mindfulness course in a general practice setting: a qualitative study. (2025) · cites this paper as [22]
The 'Subgroup analysis high versus low childhood adversity' section reports that another study suggested mindfulness-based cognitive therapy protected against depressive relapse in participants with a history of childhood trauma. That provides limited support for the depression part of the claim, but this protocol update does not establish effectiveness for stress, anxiety, or chronic pain, or for depression generally. No page number is available in our copy. (LLM, conf=0.85)
Experimental — accuracy not yet measuredMBSR has demonstrated significant benefits in stress, anxiety, depression, and chronic pain and is recommended in several guidelines.
“the extensively researched MBSR program, has demonstrated significant benefits in these areas [16–23], and are recommended in several guidelines [22, 24, 25].”
From Exploring patient experiences with a mindfulness course in a general practice setting: a qualitative study. (2025) · cites this paper as [22]
The Reworded research question section concerns mindfulness-based cognitive therapy (MBCT) and antidepressant treatment, while the Subgroup analysis section discusses a suggested MBCT effect on depressive relapse. Neither addresses MBSR’s benefits for stress, anxiety, depression and chronic pain or guideline recommendations; searches for those benefits and recommendations found no supporting passage in our copy. Page numbers were not provided. (LLM, conf=0.76)
Experimental — accuracy not yet measured
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Cites
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Meditation for Major Depressive Disorder: A Systematic Review
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- Authors
- Kuyken, W., Byford, S., Byng, R., Dalgleish, T., Lewis, G., Taylor, R., Watkins, E. R., Hayes, R., Lanham, P., Kessler, D., Morant, N., & Evans, A.
- Affiliations
- University of Exeter (GB)
- King's College London (GB)
- Peninsula College of Medicine and Dentistry (GB)
- MRC Cognition and Brain Sciences Unit (GB)
- University of Bristol (GB)
- University of Cambridge (GB)
- Corresponding author
- Kuyken, Willem
- ORCID
- Venue
- Trials
- Published
- 2014-06-10
- Volume
- 15
- Issue
- 1
- Pages
- 217-217
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC4066271
- OpenAlex
- W2166127090
- Cited by
- 13
- References
- 2
- Citations by year
- 2025: 1 · 2023: 1 · 2022: 1 · 2021: 1 · 2020: 1 · 2019: 1 · 2018: 2 · 2015: 5
- FWCI
- 1.97
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research Portal (King's College London) (publishedVersion, other-oa)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Figshare (submittedVersion)
- Open Research Exeter (University of Exeter) (submittedVersion, cc-by)
- PEARL (University of Plymouth) (submittedVersion)
- Bristol Research (University of Bristol) (submittedVersion)
- Apollo (University of Cambridge) (submittedVersion, cc-by)
- Funders
- National Institute for Health and Care Research (08/56/01)
- Bangor University
- National Institutes of Health
- Topics
- Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- mindfulness-based cognitive therapy, recurrent depression, major depressive disorder, depressive relapse prevention, antidepressant tapering, process research, mechanisms of change, mindfulness skills, cost-effectiveness, primary care
- MeSH terms
- Antidepressive Agents, Major Depressive Disorder, Humans, Research Design, Substance Withdrawal Syndrome, Cognitive Behavioral Therapy, Clinical Governance, Secondary Prevention, Mindfulness
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