درمان شناختی مبتنی بر حضور ذهن در مقابل تحصیلات روانی برای بیماران مبتلا به افسردگی اساسی پس از درمان ضد افسردگی که بهبودی به دست نمی آورند

Mindfulness-based cognitive therapy (MBCT) showed efficacy for currently depressed patients. However, most of the available studies suffer from important methodological shortcomings, including the lack of adequate control groups. The present study aims to compare MBCT with a psycho-educational control group designed to be structurally equivalent to the MBCT program but excluding the main putative “active ingredient” of MBCT (i.e., mindfulness meditation practice) for the treatment of patients with major depression (MD) who did not achieve remission following at least 8 weeks of antidepressant treatment. Out of 106 screened subjects, 43 were randomized to receive MBCT or psycho-education and were prospectively followed for 26 weeks. MD severity was assessed with the Hamilton Rating Scale for Depression (HAM-D) and the Beck Depression Inventory-II (BDI-II). Measures of anxiety, mindfulness, and quality of life were also included. All assessments were performed at baseline, 4, 8, 17 and 26-weeks. Both HAM-D and BDI scores, as well as quality of life and mindfulness scores, showed higher improvements, which were particularly evident over the long-term period, in the MBCT group than in the psycho-education group. Although limited by a small sample size, the results of this study suggest the superiority of MBCT over psycho-education for non-remitted MD subjects.

As a consequence, the present study is aimed at investigating the short-term (8 weeks) and long-term (26 weeks) effects of MBCT as compared with a psycho-educational active control group (1) on the reduction of depressive symptoms and (2) on the modulation of further clinical variables, such as anxiety symptoms and quality of life, in a sample of patients suffering from MD who did not achieve remission after at least 8 weeks of adequate antidepressant treatment.

Major depression (MD) is one of the most common psychiatric disorders in the general population, as well as one of the main causes of morbidity in the world. About 350 million people are currently thought to be affected by MD and this disorder currently represents one of the leading causes of disability worldwide (WFMH, 2012). Current pharmacological and psychological treatments have been found to significantly reduce depressive symptoms, as well social and work-related dysfunctions associated with MD (WFMH, 2012). However, available evidence shows that response and remission rates to current treatments are far from being satisfactory. Indeed, a large proportion of patients does not achieve full symptom remission, even following several treatment steps of medications and/or psychotherapy (Rush et al., 2006, Pigott et al., 2010 and Aguglia et al., 2014). Furthermore, even patients who meet remission criteria following pharmacological and/or psychological treatments carry a high risk for relapse (Ramana et al., 1995 and Hollon et al., 2005) especially when they continue to experience residual depressive symptoms (Paykel et al., 1995, Judd et al., 1999, Pintor et al., 2004 and Israel, 2010). Mindfulness-based cognitive therapy (MBCT) is a manualized 8-week meditation-based skills-training group program originally designed to prevent depressive relapse and recurrence that builds on a strong foundation of empirical research examining predictors of depressive relapse (Segal et al., 2002). It utilizes the structure and many practices of the mindfulness-based stress reduction program (MBSR) developed by Kabat-Zinn (1990) and it includes elements of cognitive behavioral therapy for MD (Beck et al., 1979), such as psycho-education about the cognitive model of MD. By means of mindfulness meditation practice, MBCT teaches patients to become more aware of their incoming thoughts, feelings, and bodily sensations, and to relate to them with an accepting and nonjudgmental attitude. The main aim of the program is to help patients who have suffered from MD to develop a “decentered” perspective toward their inner experience in order to become more aware of and to relate differently to the dysfunctional and automatic cognitive styles – and related emotional responses – that underpin depressive relapse/recurrence (Segal et al., 2002). Consistent evidence has suggested so far the superiority of MBCT plus treatment as usual (TAU) over TAU alone or placebo, as well as the comparable efficacy of MBCT associated with gradual discontinuation of pharmacotherapy with maintenance pharmacotherapy alone or psycho-education, for the prevention of MD relapse in patients with three or more prior depressive episodes (Chiesa and Serretti, 2011, Piet and Hougaard, 2011 and Williams et al., 2014). On the basis of these findings, MBCT has been recommended by international guidelines as a treatment choice for relapse prevention in recurrent MD patients (National Institute of Health and Clinical Excellence, 2009, American Psychiatric Association, 2010 and Crane and Kuyken, 2013). In addition, more recent studies have shown that MBCT can be efficacious for patients suffering from acute MD (Barnhofer et al., 2009, Manicavasgar et al., 2011, van Aalderen et al., 2012, Omidi et al., 2013 and Strauss et al., 2014), for patients with residual depressive symptoms – regardless of the number of previous depressive episodes (Kingston et al., 2007, Geschwind et al., 2012 and Batink et al., 2013), as well as for patients suffering from treatment-resistant MD (Kenny and Williams, 2007 and Eisendrath et al., 2008). Despite these encouraging findings, it is worth mentioning that most of the available studies on MBCT suffer from important methodological shortcomings. A main shortcoming of these studies concerns the lack of a control group or the comparison between MBCT and inactive control groups (i.e., waiting lists) that do not allow to distinguish between the specific effects of MBCT, such as those related to mindfulness meditation practice, and the non-specific effects of treatment, such as benefit’s expectation, teacher’s care, and group support (Chiesa and Serretti, 2011 and Goyal et al., 2014). Pertaining to the reduction of depressive symptoms in currently depressed patients, only a few studies have compared MBCT with active comparators so far. As an example, employing a randomized controlled design, Manicavasgar et al. (2011) recently found in a sample of 45 patients suffering from non-melancholic MD that MBCT could be as effective as group cognitive-behavior therapy on the reduction of depressive symptoms. More recently, Omidi et al. (2013) confirmed and extended these findings in a sample of 90 subjects randomized to MBCT, cognitive-behavior therapy or to a waiting list. In this study MBCT was as effective as cognitive behavior therapy and both active treatments were superior to the waiting list on the reduction of several psychological outcome measures including depressive symptoms (Omidi et al., 2013). Although both studies compared MBCT with active control groups, which efficacy for MD had already beeen established, none of them helped distinguish between the specific effects of MBCT and the non-specif effects of treatment that are thought to be common to all group psychological treatments. Furthermore, both studies were limited by the lack of an a priori power calculation that did not allow to understand to what extent the similar efficacy observed between MBCT and active control groups was actually the result of a lack of statistical power rather than of a real comparable efficacy of the two interventions. A possible way to overcome this limitation could be to directly compare MBCT with a control group designed to be structurally equivalent to the MBCT program but excluding the main claimed “active ingredient” of MBCT, i.e., mindfulness meditation practice, for the treatment of symptomatic patients with MD. A further limitation of the majority of previous studies focusing on non-remitted MD patients is the dearth of follow-up data following the end of the treatment period (Kingston et al., 2007, Crane et al., 2008, Barnhofer et al., 2009 and Omidi et al., 2013). It is therefore largely unknown the extent to which benefits observed over the short-term period tend to maintain over the long-term period as well. Fig. 1 shows the patient flow from screening to follow-up. One-hundred and six (106) people were screened for the study and 50 were considered eligible for inclusion. Fifty-six (56) subjects were excluded because they did not meet the inclusion criteria. More in detail, 29 subjects did not meet diagnostic criteria, 18 subjects were not on adequate antidepressant treatment and nine subjects did not meet other inclusion criteria. Eligible patients were randomized to either MBCT (n=26) or psycho-education (n=24). Three (3) subjects in the MBCT group and four subjects in the psycho-education group dropped out before the first session and did not return baseline questionnaires and were therefore excluded from the analyses. As a consequence, our modified ITT sample consisted of 43 patients. Ten (10) participants dropped out during the study period – four from the MBCT group and six from the psycho-educational group ( Fig. 1). Clinical and socio-demographic variables of the ITT sample are shown in Table 1 and Table 2. No significant difference was observed between the two groups in terms of clinical and socio-demographic variables.