Research paperRecovery from recurrent depression: Randomized controlled trial of the efficacy of mindfulness-based compassionate living compared with treatment-as-usual on depressive symptoms and its consolidation at longer term follow-up
Introduction
Major depressive disorder (MDD) is characterised by persistent symptoms and high relapse rates (Mueller et al., 1999). Mindfulness-based cognitive therapy (MBCT) has been demonstrated to reduce the risk of a relapse/recurrence in patients with recurrent depression in remission in a 60-week follow-up period by 31% (Kuyken et al., 2016). Given their high psychological, social and economic burden as well as their predictive value in terms of relapse, the treatment of current depressive symptoms is also very important (Hardeveld, Spijker, De Graaf, Nolen, & Beekman, 2010). A growing number of studies indicate that MBCT may also be effective in decreasing depressive symptoms in patients with current depression (Strauss, Cavanagh, Oliver, & Pettman, 2014). However, residual symptoms seem to remain considerable even after MBCT (Piet and Hougaard, 2011), leaving substantial room for further improvement.
Reduction of rumination is one of the most established working mechanisms of MBCT. A meta-analysis by Van der Velden et al. (N = 23; Van der Velden et al., 2015) reported that alterations in rumination, worry and meta-awareness were associated with, predicted or mediated MBCT outcome. However, not only reduction in rumination and increase in mindfulness skills were demonstrated to be mediators of treatment outcome, also compassion. Since one of the possible underlying mechanisms for the chronic and recurrent nature of MDD is low self-esteem or self-denigration (Gilbert & Procter, 2006), the finding that compassion mediates MBCT's treatment effect is interesting. Being able to adopt a caring attitude towards the self might be a skill that could help reduce the undermining mechanisms of self-criticism and hence reduce the vulnerability to recurrence or persistence of depressive symptoms. As self-compassion is taught mostly implicitly in MBCT (Segal et al., 2012), the explicit cultivating of self-compassion may pay a complementary contribution to reduction of rumination and increase in mindfulness skills in the prevention of depressive relapse or recurrence, or reduction of depressive symptoms.
To this end, Van den Brink and Koster (2015) developed mindfulness-based compassionate living (MBCL), a training to cultivate compassion in patients who previously participated in MBCT. The advantage of offering MBCL as a follow-up to MBCT is that participants have already laid the foundation of non-judgmental, present-moment awareness before exposing themselves more actively to difficult, painful experiences with a (self)compassionate attitude. A first pilot study on MBCL in patients with a variety of psychiatric disorders who previously followed mindfulness-based stress reduction (MBSR) or MBCT showed a reduction in depressive symptoms and increases in both mindfulness and self-compassion skills (Bartels-Velthuis et al., 2016). A pilot study of our own group showed that MBCL appeared to be feasible and acceptable in 17 patients with recurrent depression who previously followed MBCT, and demonstrated some preliminary improvements of depression and self-compassion (Schuling et al., 2017). The pilot was primarily focused on facilitators and barriers of MBCL, which helped us tailor it to our population by using a qualitative co-creation design.
Offering MBCL after MBCT could be conceptualised as a sequential treatment. Sequential treatment designs are more commonly known in both pharmacological treatments of depression (Popova et al., 2019) and the combination of pharmacotherapy and psychological treatment (Cuijpers et al., 2020). In contrast, MBCT and MBCL are both psychological treatments.
Targeting depressive symptoms with a double or sequential treatment has particular advantages: it allows randomization of patients to treatment alternatives according to stages of development of their illness and not simply to disease classification. The model is thus more in line with the chronicity of mood disorders compared to the standard randomized controlled trial, which is based on the acute disease model (Fava and Tomba, 2010). In addition, sequential treatment seems to be more effective than single treatments (Cuijpers et al., 2020). Given the percentage of people that doesn't improve with a primary treatment, using additional treatment in a sequence seems a fruitful approach. One option is to follow a pragmatic approach, offering the second treatment to a population that has already followed the first (Daly et al., 2018). Ideally however, the efficacy is tackled by a prospective study offering both treatments in sequence to a population that has received neither before (Popova et al., 2019). As little is known about MBCL efficacy in patients with recurrent depression, we decided to use the pragmatic approach by offering MBCL to a population that had previously followed MBCT.
In this paper, two studies are reported. Study 1 is an RCT comparing MBCL and TAU in their efficacy to further reduce depressive symptoms in patients with recurrent depression who previously participated in MBCT. As secondary outcomes in the RCT we assess current depression status, rumination, self-compassion, mindfulness and quality of life. We also examine possible mediators and moderators of treatment outcome. Study 2 is an uncontrolled follow-up study of both the original MBCL condition and the patients who were offered MBCL after completion of TAU to investigate the consolidation of treatment outcome using the same outcome measures.
Section snippets
Study design
The first study was a parallel-group RCT, in which patients who had previously participated in MBCT were randomized to MBCL combined with TAU or TAU alone. Assessments took place at baseline and after treatment (four months after baseline). The study was carried out at the Radboudumc Centre for Mindfulness in the Netherlands, from July 2013 to April 2015, with follow-up assessments continuing until November 2015. The protocol was approved by the ethical review board CMO Arnhem-Nijmegen
Design
The second study is an uncontrolled follow-up study of the combined sample of the patients in the initial MBCL group and those who received MBCL after having completed the TAU period of four months in the control condition. In this study, we used the end-of-control assessment as baseline for the participants who had been randomized to TAU only. Further assessments for this study took place after treatment and at six months after completion of treatment. All RCT outcome measures were used in
Participant flow and characteristics
A total number of 122 patients were included in the study (MBCL+TAU: n = 61, TAU: n = 61; cf. Fig. 1a for a detailed description of the patient flow). The average time elapsed since participating in MBCT was 4,1 years for the MBCL group vs. 4,5 for the TAU group (range 1–7 years). In total, 11 groups were delivered, containing an average of 5,5 MBCL + TAU participants per group. The first group only contained MBCL + TAU participants, after this, the groups were mixed between MBCL + TAU and TAU
Participant flow and characteristics
From the 61 patients assigned to the control group, n = 57 (93%) accepted the invitation to participate in the MBCL after completion of the TAU period. So, the combined sample of both the original MBCL group and the patients who received MBCL after the TAU group was N = 119. Average attendance overall was 6,2 sessions (SD: 2,4). The flow of participants from RCT to the 6-months follow-up is presented in Fig. 1b. The baseline characteristics of the combined group can be found in Table 1.
Change of primary and secondary outcome measures
From
Summary and comparison with the literature
The present study is the first trial examining the efficacy of MBCL in patients with recurrent depression, who previously followed MBCT. Our findings indicate that MBCL, offered as a sequential intervention to MBCT, results in a significant reduction of depressive symptoms at post-treatment (d = 0.34), corresponding with a number-to-treat of five. Furthermore, we found a reduction of rumination and improvements in self-compassion, mindfulness skills and quality of life in MBCL versus TAU. In
Author Contribution
Ms. Schuling was involved in the design of the trial, the collection, analysis and interpretation of data and in writing and submitting the paper. Dr Huijbers was involved in the design of the trial, the analysis and interpretation of data and in writing the paper. Dr Van Ravesteijn was involved in the design of the trial, the collection and interpretation of data and in writing the paper. Ms. Cillessen was involved in the analysis and interpretation of the follow-up data and in writing the
Funding
This study was funded by the Radboud University Medical Centre and the Meditation Awareness and Peace Research Fund of the Triodos Foundation. Both did not contribute to study design or writing of the paper, nor in the decision for publication.
Declaration of Competing Interest
The clinical research team declares it had no part in developing the MBCL programme, though Prof. Speckens and Ms. Schuling made modifications to it in collaboration with the original developers following the pilot study (Schuling et al., 2017). The team does not gain income from the sale of books on MBCL, nor does it gain income from giving lectures or workshops about it. Prof. Speckens is founder and clinical director of the Radboudumc Centre for Mindfulness. Ms. Schuling, Dr Van Ravesteijn,
Acknowledgements
We would like to express our gratitude to the Meditation Awareness and Peace Research Fund of the Triodos Foundation, which provided financial support of this study. We also thank Hetty Jansen and Renée Metzemaekers for teaching the MBCL, Rosalie van Woezik, Heidi Willemse and Indah Kuiper for their help with data collection and processing, and Ramona van Stuyvenberg-Monfils and Irma Veliscek-van Maren for their help with patient recruitment. Finally, we wish to acknowledge all participants for
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