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Cited by 43Mindfulness and Compassion InterventionsTreatment of Major DepressionAnxiety, Depression, Psychometrics, Treatment, Cognitive Processes

Adding mindfulness-based cognitive therapy to maintenance antidepressant medication for prevention of relapse/recurrence in major depressive disorder: Randomised controlled trial

Open access
Huijbers, Marloes J., Spinhoven, Philip, Spijker, Jan, Ruhé, Henricus G., van Schaik, Digna J.F., van Oppen, Patricia, Nolen, Willem A., Ormel, Johan +6 more·2015·Journal of Affective Disorders
DOI 10.1016/j.jad.2015.08.023
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Abstract

Background Mindfulness-based cognitive therapy (MBCT) and maintenance antidepressant medication (mADM) both reduce the risk of relapse in recurrent depression, but their combination has not been studied. Our aim was to investigate whether the addition of MBCT to mADM is a more effective prevention strategy than mADM alone.Methods This study is one of two multicenter randomised trials comparing the combination of MBCT and mADM to either intervention on its own. In the current trial, recurrently depressed patients in remission who had been using mADM for 6 months or longer (n=68), were randomly allocated to either MBCT+mADM (n=33) or mADM alone (n=35). Primary outcome was depressive relapse/recurrence within 15 months. Key secondary outcomes were time to relapse/recurrence and depression severity. Analyses were based on intention-to-treat.Results There were no significant differences between the groups on any of the outcome measures.Limitations The current study included patients who had recovered from depression with mADM and who preferred the certainty of continuing medication to the possibility of participating in MBCT. Lower expectations of mindfulness in the current trial, compared with the parallel trial, may have caused selection bias. In addition, recruitment was hampered by the increasing availability of MBCT in the Netherlands, and even about a quarter of participants included in the trial who were allocated to the control group chose to get MBCT elsewhere.Conclusions For this selection of recurrently depressed patients in remission and using mADM for 6 months or longer, MBCT did not further reduce their risk for relapse/recurrence or their (residual) depressive symptoms.

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Written from the paper’s full text.

TL;DR

In recurrently depressed patients in remission who had been taking maintenance antidepressant medication (mADM) for at least 6 months, adding mindfulness-based cognitive therapy (MBCT) did not reduce relapse/recurrence over 15 months compared with mADM alone. No significant group differences were found on relapse/recurrence, time to relapse, depressive symptoms, relapse characteristics, or quality of life.

Key findings

  • Relapse/recurrence rates were similar: 36% (12/33) with MBCT + mADM vs 37% (13/35) with mADM alone in the intention-to-treat sample (χ² = 0.004; p = 0.95); per-protocol rates were 39% (9/23) vs 48% (10/21), respectively (χ² = 0.32; p = 0.57).
  • Time to relapse/recurrence did not differ: intention-to-treat hazard ratio = 0.87 (95% CI 0.40–1.90; p = 0.72); per-protocol hazard ratio = 0.75 (95% CI 0.31–1.85; p = 0.53).
  • No significant differences were found for severity of residual depressive symptoms over follow-up, number/duration/severity of relapse/recurrence, or quality of life.
  • MBCT completion was 28/33 (85%) in the MBCT + mADM group; in the mADM-only group, 8/35 (23%) received MBCT as a protocol violation. Mean teacher competency was 3.4 (SD 0.7, range 2.2–4.3).

Methods

  • Multicenter randomised controlled trial in twelve university and secondary mental health centres in the Netherlands, recruiting September 2009–January 2012; 68 patients with at least three prior depressive episodes, in full or partial remission, and using antidepressant medication for at least 6 months were randomised to MBCT + mADM (n = 33) or mADM alone (n = 35).
  • Primary outcome was depressive relapse/recurrence within 15 months, assessed with the SCID-I every three months; secondary outcomes included time to relapse/recurrence, IDS-C depressive symptom severity, relapse number/duration/severity, and WHOQOL quality of life.
  • Analyses were intention-to-treat and per-protocol, using Pearson χ² tests, Cox regression, latent growth curve modelling, and repeated measures ANOVA; the planned sample size was 96 participants, but only 68 were recruited.

Limitations

  • The authors state that the trial included patients who preferred the certainty of continuing medication over possibly participating in MBCT, which may have caused selection bias and lower expectations of mindfulness; recruitment was also hampered by increasing MBCT availability, and about a quarter of control-group participants chose to get MBCT elsewhere.
  • The authors state the study was underpowered because recruitment stopped before reaching the required sample size, and that overall teacher competency was lower than in previous studies, possibly attenuating MBCT effects.
  • The text makes evident that research assistants conducting assessments could not be blinded to treatment condition because they were involved in practical trial organisation.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

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Crossref · 10.1016/j.jad.2015.08.023

Cites

47 of 47 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 50 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    There was no significant difference in relapse/recurrence rates between MBCT+mADM and mADM alone in the ITT sample (36% vs 37%, χ2=0.004, p=0.95).

    “No differences in relapse/recurrence rates were observed between MBCT þmADM and mADM.In the ITT sample, the relapse/ recurrence rate was 36% (12/33) in the combination group and 37% (13/35) in the mADM only group (χ 2 ¼0.004; p¼ 0.95).”
    Quote in the paperSubstantial claim
  • Findingown data

    There was no difference in time to relapse/recurrence between the two conditions in the ITT sample (HR=0.87, 95% CI 0.40-1.90, p=0.72).

    “Cox regression analyses showed that there was no difference in time to relapse/recurrence between the two conditions for both ITT (hazard ratio ¼ 0.87, 95% confidence interval 0.40-1.90;p ¼0.72)”
    Quote in the paperSubstantial claim
  • Findingown data

    On average, patients maintained mild levels of depression throughout the study period.

    “On average, patients maintained mild levels of depression throughout the study period (Fig. 3).”
    Quote in the paperNot a substantial claim
  • Findingown data

    For patients experiencing a relapse/recurrence, there were no differences between the conditions in number of relapses/recurrences during the 15-month follow-up (ITT: χ2=0.10, p=0.75; PP: χ2=0.02, p=0.88).

    “For those patients experiencing a relapse/recurrence, there were no differences between the conditions in terms of number of relapses/recurrences during the 15-month follow up period (ITT: χ 2 ¼ 0.10, p¼ 0.75; PP: χ 2 ¼ 0.02, p¼ 0.88)”
    Quote in the paperNot a substantial claim
  • Findingown data

    There were no differences between the conditions in severity of first relapse/recurrence (ITT: χ2=3.44, p=0.18; PP: χ2=0.57, p=0.75).

    “or severity of (first) relapse/recurrence (ITT: χ 2 ¼3.44, p ¼0.18; PP: χ 2 ¼0.57, p¼ 0.75).”
    Quote in the paperNot a substantial claim
  • May combine two claims. 10
  • Classified as probably not a substantial claim. 23

  • May combine two claims.

    Findingown data

    In the PP sample, the difference in relapse/recurrence rates was somewhat greater but not significant (39% vs 48%, χ2=0.32, p=0.57).

    “In the PP sample, the difference in relapse/recurrence rates was somewhat greater, but not significantly so: 39% (9/23) in the combination group and 48% (10/21) in the medication only group (χ 2 ¼0.32; p¼ 0.57).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    In the mADM group, more patients used selective serotonin reuptake inhibitors, whereas in the combination group, more patients used tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, monoamine oxidase-inhibitors, or mirtazapine.

    “In the mADM group, more patients used selective serotonine reuptake inhibitors, whereas in the combination group, more patients used tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, monoamine oxidase-inhibitors, or mirtazapine.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation

    Most recurrently depressed patients preferred MBCT and chose to participate in the parallel trial (n=249), while a minority preferring to hold on to their mADM chose the current trial (n=68).

    “As shown in Fig. 1, most recurrently depressed patients preferred MBCT and chose to participate in the parallel trial (n ¼249; Huijbers et al., in press).A minority preferring to hold on to their mADM chose to participate in the current trial (n¼ 68).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Huijbers et al., in press

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The latent growth curve analysis for severity of (residual) depressive symptoms over the 15-month follow-up period showed a good model fit (χ2(df=20)=16.18, n=68, p=0.71, CFI=1.00, RMSEA=0.00, SRMR=0.07).

    “The latent growth curve analysis for severity of (residual) depressive symptoms (IDS-C) over the 15-month follow-up period showed a good model fit with χ 2 (df¼20) ¼16.18 (n ¼68), p¼ 0.71, comparative fit index ¼1.00,root mean square error of approximation¼ 0.00 and standardised root mean square re-sidual¼0.07.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Premisecitation

    MBCT is recommended for patients in remission who are at high risk of depressive relapse/recurrence.

    “Based on this evidence, MBCT is recommended for patients in remission who are at high risk of depressive relapse/recurrence (National Institute for Health and Care Excellence, 2009;Spijker et al., 2013).”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites National Institute for Health and Care Excellence, 2009

      Not checked in the free run.

    • cites Spijker et al., 2013

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Meta-analyses showed that the combination of medication and psychological therapy was more effective than monotherapy in both current MDD and prevention of relapse/recurrence.

    “Meta-analyses indeed showed that the combination of medication and psychological therapy was more effective than monotherapy in both current MDD (Cuijpers et al., 2014;de Maat et al., 2008;Pampallona et al., 2004) and prevention of relapse/ recurrence (Guidi et al., 2011).”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites Cuijpers et al., 2014 source

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    • cites de Maat et al., 2008 source

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    • cites Pampallona et al., 2004 source

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  • Classified as probably not a substantial claim.

    Premisecitation

    Results from a more recent trial indicate that MBCT may be particularly useful for patients who are using ADM.

    “results from a more recent trial indicate that MBCT may be particularly useful for patients who are using ADM (Meadows et al., 2014).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Meadows et al., 2014 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Previous neuroimaging research suggested that medication and psychotherapy for depression involve different neural pathways.

    “Previous neuroimaging research indeed suggested that medication and psychotherapy for depression involve different neural pathways (Goldapple et al., 2004).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Goldapple et al., 2004 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Teacher competency was assessed by two independent expert raters using the Mindfulness-Based Interventions: Teaching Assessment Criteria on randomly selected video tapes of MBCT sessions.

    “Video tapes of the MBCT sessions were available for nine teachers.Two tapes per teacher were randomly selected and teacher competency was examined by two independent expert raters using the Mindfulness-Based Interventions: Teaching Assessment Criteria (English version) (Crane et al., 2013).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Crane et al., 2013

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    The research assistants conducting the assessments could not be blinded to treatment condition because they were also involved in the practical organisation of the trial.

    “The research assistants conducting the assessments could not be blinded to treatment condition since they were also involved in the practical organisation of the trial.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    There were no effects of research site on relapse/recurrence, so site was not included in the statistical models.

    “As there were no effects of research site on relapse/recurrence, we did not include site in our statistical models.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In the mADM condition, 8/35 patients (23%) received MBCT, which was a protocol violation.

    “In the mADM condition, 8/35 patients (23%) received MBCT (protocol violation).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The IDS-C has good psychometric qualities.

    “The IDS-C has good psychometric qualities (Rush et al., 1996).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Rush et al., 1996 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In the MBCT+mADM condition, 28/33 patients (85%) completed MBCT.

    “In the MBCT þmADM condition, 28/33 patients (85%) completed MBCT.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    Regression analyses were performed with and without adjustment for depressive symptoms at baseline and number of depressive episodes in the past (log transformed), factors known to predict relapse/recurrence.

    “Regression analyses were performed with and without adjustment for depressive symptoms at baseline and number of depressive episodes in the past (log transformed), factors known to predict relapse/recurrence (Hardeveld et al., 2010).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Hardeveld et al., 2010 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Teacher competency assessment showed that one teacher was characterised as beginner, four as advanced beginners, and four as competent; the mean teacher competency score was 3.4 (SD 0.7, range 2.2-4.3).

    “The teacher competency assessment showed that one teacher was characterised as beginner, four as advanced beginners, and four as competent.The mean teacher competency score was 3.4 (SD 0.7, range 2.2-4.3).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    A total of 96 participants (48 per group) was needed to demonstrate a difference of 25%, with a power of 0.80 and alpha of 0.05.

    “For the sample size calculation we refer to the published protocol (Huijbers et al., 2012).A total of 96 participants (48 per group) was needed to demonstrate a difference of 25%, with a power of 0.80 and alpha of 0.05.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Huijbers et al., 2012 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Follow-up assessments were incomplete for 12/68 participants (18%), of whom 8/68 (12%) did not complete any follow-up assessment.

    “Follow-up assessments were incomplete for 12/68 participants (18%) of whom 8/68 (12%) did not complete any follow-up assessment.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    For patients with recurrent depression in remission, adding MBCT to mADM does not seem to reduce relapse/recurrence rate, time to relapse, number, duration and severity of relapse/recurrence, severity of depressive symptoms, or quality of life.

    “Based on the results of the current study, adding MBCT to mADM for patients with recurrent depression in remission does not seem to reduce relapse/recurrence rate, time to relapse, number, duration and severity of relapse/recurrence, severity of depressive symptoms, or quality of life.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The MBCT delivered in this trial was of sufficient quality to produce its intended effect.
    • Rests on an assumption: The 23% of control participants who received MBCT elsewhere did not dilute a true effect of MBCT+mADM.
    • Rests on an assumption: The adapted MBCT protocol (2.5-hour sessions and one day of silent practice) is as effective as standard MBCT.

  • May combine two claims.

    Interpretationreasoning

    Patients participating in the current trial might have had lower expectations and less commitment to MBCT.

    “Hence, patients participating in the current trial might have had lower expectations and less commitment to MBCT.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

    Interpretationreasoning

    The increasing availability of MBCT in the Netherlands in recent years might have strengthened this attenuation.

    “This might have been even strengthened by the increasing availability of MBCT in the Netherlands in recent years.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Interpretationreasoning

    The high adherence rate might be a consequence of our optimisation of mADM in the control condition.

    “possibly as a consequence of our optimisation of mADM in the control condition”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationreasoning

    The wide range of teachers with different levels of experience can also be considered as a strength in terms of generalisability.

    “In terms of generalisability, the wide range of teachers with different levels of experience can also be considered as a strength.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Literature on patient factors predicting treatment response to MBCT is emerging but still in its infancy, particularly compared to predictors of outcome of cognitive therapy.

    “Literature on patient factors predicting treatment response to MBCT is emerging but still in its infancy, particularly compared to predictors of outcome of cognitive therapy (DeRubeis et al., 2014).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites DeRubeis et al., 2014 source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Interpretationreasoning

    This might have left relatively little room for further improvement.

    “This might have left relatively little room for further improvement.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Interpretationreasoning

    This difference might be related to the study being underpowered.

    “but this might also be related to the study being underpowered.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductown data

    Almost a quarter of those who had consented to participate in the trial but were randomised to the control condition decided to nevertheless participate in an MBCT course elsewhere, thus further compromising the ITT analyses.

    “To make matters worse, almost a quarter of those who had consented to participate in the trial but were randomised to the control condition decided to nevertheless participate in an MBCT course elsewhere, thus further compromising the ITT analyses.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Higher severity of childhood trauma is associated with better treatment response to MBCT.

    “higher severity of childhood trauma (Williams et al., 2014)”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Williams et al., 2014 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Residual symptoms are associated with better treatment response to MBCT.

    “residual symptoms (Segal et al., 2010)”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Segal et al., 2010 source

      Not checked in the free run.

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  • The paper relies on this without support.

    The MBCT delivered in this trial was of sufficient quality to produce its intended effect.

    “The teacher competency assessment showed that one teacher was characterised as beginner, four as advanced beginners, and four as competent.The mean teacher competency score was 3.4 (SD 0.7, range 2.2-4.3).”

  • The paper relies on this without support.

    The 23% of control participants who received MBCT elsewhere did not dilute a true effect of MBCT+mADM.

    “In the mADM condition, 8/35 patients (23%) received MBCT (protocol violation).”

  • The paper relies on this without support.

    The adapted MBCT protocol (2.5-hour sessions and one day of silent practice) is as effective as standard MBCT.

    “MBCT was largely based on the protocol by Segal et al. (2002) with some adaptations.The intervention consisted of 8 weekly sessions of 2.5 (instead of 2) h and one day of silent practice between the 6th and 7th session (which originates from the MBSR curriculum (Kabat-Zinn, 1990) and is suggested in the most recent version of the MBCT protocol (Segal et al., 2012)).”
3 of 3

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  • Conflicting descriptions of medication use in the Godfrin trial

    Minor

    The paper first says the Godfrin and van Heeringen trial excluded patients using antidepressant medication at baseline, but later lists the same trial among studies that allowed participants to stay on maintenance antidepressant medication.

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Authors
Huijbers, M. J., Spinhoven, P., Spijker, J., Ruhé, H. G., van Schaik, D. J. F., van Oppen, P., Nolen, W. A., Ormel, J., Kuyken, W., van der Wilt, G. J., Blom, M. B. J., Schene, A. H., Donders, A. R. T., & Speckens, A. E. M.
Affiliations
  • Radboud University Medical Center (NL)
  • Leiden University (NL)
  • Pro Persona (NL)
  • University Medical Center Groningen (NL)
  • Warneford Hospital (GB)
  • Parnassia Groep (NL)
Corresponding author
Huijbers, Marloes J.
ORCID
Venue
Journal of Affective Disorders
Publisher
Elsevier BV
Published
2015-11
Volume
187
Pages
54-61
ISSN
0165-0327 (ISSN-L)
DOI
10.1016/j.jad.2015.08.023
OpenAlex
W1919773246
Semantic Scholar
7b4f8d12a7bce207f654b863e793d860ce12afde
Cited by
43
References
47
Citations by year
2025: 2 · 2024: 3 · 2023: 2 · 2022: 1 · 2021: 1 · 2020: 7 · 2019: 8 · 2018: 6 · 2017: 5 · 2016: 7 · 2014: 1
FWCI
7.45
Type
journal article
Language
en
Open access
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of Affective Disorders (publishedVersion)
  • PubMed (publishedVersion)
  • Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
  • Radboud Repository (Radboud University) (submittedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
  • Leiden Repository (Leiden University) (submittedVersion)
  • Pure Amsterdam UMC (submittedVersion)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
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, major depressive disorder, relapse prevention, recurrence prevention, recurrent depression, remission, combination therapy, residual depressive symptoms
MeSH terms
Antidepressive Agents, Depressive Disorder, Major, Major Depressive Disorder, Female, Humans, Male, Middle Aged, Netherlands, Recurrence, Cognitive Behavioral Therapy, Treatment Outcome, Mindfulness

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