Efficacy of MBI for Depressive Symptoms in Patients With MS
Condition: Multiple Sclerosis; Depression
MeSH terms: Multiple Sclerosis; Sclerosis; Depression
Study type: Interventional

Summary: 
      Multiple Sclerosis has a great impact on psychological functioning of patients and can be
      associated with various psychological disorders and symptoms. The most prevalent one is
      depression, which ranges from 15% to 47%. Mindfulness Based Intervention (MBI) is a
      relatively brief and cost-effective program that has been studied in patients with several
      diseases.

      Aims. To evaluate the efficacy of a group-based MBI on depressive symptoms, QoL and on
      correlated symptoms of MS patients and their caregivers.

      Methods. The study design is a randomized controlled clinical trial. The subjects of the
      study are 88 patients with MS and depressive symptoms that will be pre-screened from among a
      catchment group of about 500 patients using the Beck Depression Inventory-II (BDI). The 88
      patients will subsequently be randomized into two groups (44 in the experimental group and 44
      in the active control group). The psychological assessment, independent and blind to
      treatment, will be performed with the same timing and tools: at baseline (T0), after
      treatment (T1), and 6 months after the end of the group intervention (T2). The assessment
      will encompass the administration of the clinical interview and other self-report
      questionnaires.

      The experimental group will undergo a 8 weekly sessions of 3 hours each (plus an all day
      session) with group based MBI. The MBI is an Mindfulness Based Stress Reduction protocol
      integrated with body centered techniques from Sensorimotor Psychotherapy, in order to better
      tailor it on the needs of people with MS suffering from depressive symptoms. The active
      control group is designed to control for the non-specific elements of the MBI treatment and
      will follow the same structure as the MBI. It will be based on a psycho-educational framework
      and will include relaxation techniques.

      Primary outcome measures in patients will be: 1) the proportion of participants at T1 and T2
      that does not have a BDI-II score greater than 13; 2) the proportion of patients no longer
      meeting the diagnostic criteria for mood disorders as assesses by the SCID; 3) the
      improvement of FAMS scores for the six primary aspects of QoL.
    

Detailed description: 
      Multiple Sclerosis (MS) can be associated with various psychological disorders and symptoms.
      Depression is present in about 15-47% of MS patients, and it is estimated to be three times
      greater than the general population.

      Anxiety and depression are closely associated, both independently and in interaction, with
      fatigue. Mohr et al. (2003) have shown that improvements of depressive symptoms are closely
      associated with a decrease in the severity of fatigue. These symptoms represents the most
      disabling symptoms that have heavy psychosocial consequences for patients, for example
      affecting relationships, leisure activities and employment. Given also the young age at which
      MS occurs it is important that these symptoms be adequately recognized and treated to prevent
      their chronicity.

      A recent study on psychological treatment of depressive symptoms in patients with medical
      disorders stated that treating comorbid depression should be one of the priorities in medical
      care settings. Feinstein (2011) highlighted that treatments for depression in public health
      care services may also be adjusted according to the availability of resources and access to
      them. Thereby it is essential to establish brief and cost-effective interventions to reduce
      depression symptoms and the psychological burden and to improve the Quality of Life (QoL) of
      these patients.

      Mindfulness-based interventions have been proven effective in improving depressive symptoms
      and in enhancing QoL in many different chronic conditions and recently also in MS patients.

      Mindfulness could be defined as a nonjudgmental awareness and acceptance of one's
      moment-to-moment experience. As described by Bishop et al. (2004), mindfulness consist of two
      main component: the self- regulation of attention and a particular orientation toward the
      experience. Self-regulation of attention concern the nonjudgmental observation and awareness
      of physical sensations, affective states and thoughts as they arise. Orientation to
      experience refers to the attitude of acceptance and curiosity toward one's experience.
      Mindfulness has an effect on the distressing tendencies to escape from or to over-engage with
      one's disturbing feelings and thoughts.

      Several studies have highlighted the effects of mindfulness on psychological health: ithas
      been associated with higher levels of QoL, life satisfaction, self-esteem, empathy,
      self-compassion,sense of autonomy and competence among both clinical and non-clinical
      populations. In addition, thesestudies have shown a negative correlation between mindfulness
      and negative affect and psychopathologicalsymptoms, such as depressive symptoms, rumination,
      anger, difficulties in emotion regulation, and social anxiety.

      These studies also showed the efficacy of MBI in improving anxiety and depression symptoms
      related with physical illnesses like cancer, chronic fatigue syndrome, fibromyalgia, chronic
      pain, arthritis, diabetes, heart disease, stroke, and traumatic brain injury.

      Several studies of neuroimaging and on biological markers have also pointed out the effects
      of mindfulness on a neurobiological level, showing its effects on the regulation of emotional
      responses through the inhibition of amygdala by a proper functioning of the prefrontal cortex
      and in an altered cortisol and immune patterns consistent with less stress and mood
      disturbance, and decreased blood pressure.

      In recent years, there has been a widespread of mindfulness-based approaches, generically
      called Mindfulness Based Intervention (MBI), that are based upon MBSR but also incorporate
      techniques derived from clinical psychology and psychotherapy, which mainly focus on emotion
      regulation, on the development of somatic resources, on self-compassion (directed both
      towards themselves and towards others, i.e. loving kindness and compassion meditation, and
      that have a greater focus than MBSR on mind-body integration and on interpersonal
      relationships.

      MBI are considered as an effective and cost-effective treatment addressing the difficulties
      derived from the serious psycho-social impact of highly disabling chronic diseases, such as
      MS, by changing a range of emotional and evaluative dimensions that underlie general aspects
      of well-being. MBI can be therefore useful in counteract the suffering caused by the
      symptoms, the fatigue, the depressive and anxiety symptomatology and the distress in dealing
      with the disability. A key objective of the MBI interventions is the improvement of QoL.

      Moreover, some studies reported that stress may be one factor that influences the risk of MS
      exacerbation. This highlights even more the importance of developing interventions aimed at
      reducing stress in patients with MS. The study of Grossman et al. (2010), to our knowledge
      the only study that evaluates the efficacy of a group MBI in MS by comparing it with the
      usual care, showed that a cost-effective and relatively brief group intervention may improve
      a broad range of parameters of well-being of patients with MS.

      This study has some limitations that our research project aims to overcome, such as the lack
      of a control group to assess the specificity of MBI, and the lack of objective measures of
      emotional measures and psychopathological symptoms.

      In our project, we propose to include an active control intervention (psycho-education plus
      relaxation) in addition to usual care, and to assess the psychological functioning of MS
      patients with a semi-structured clinical interview (SCID) in addition to the self-report
      measures.

      Moreover, we aim to evaluate the efficacy of the MBI in MS patients who have depressive
      symptoms, measured as having a score greater than 13 at the Beck Depression Inventory-II. The
      NICE guidelines (2009) indicate that psychological interventions such as mindfulness or
      psycho-education, combined with drug therapies or alternative to them depending on the case,
      resulted more effective both in terms of efficacy and in term of cost-effectiveness compared
      to drug therapy alone. Also as highlighted by Hofmann et al., (2010) MBI may be more
      effective in populations with mood disorders.

      Furthermore, our project aims to involve patients' caregivers asking them to participate in
      the group to which the patient has been assigned. We expect that caregivers will benefit from
      the treatment received, due to the load of stress and difficulties related to the management
      of a chronic disabling diseases like MS. Furthermore, a recent study has shown that patients'
      depressive state influenced the deterioration of QoL and the depression of caregivers. In
      fact the MBI does not deal directly with the disease, but with the attitude of relating to
      the self, the others and to life. Finally, our project is based on MBSR protocol but in order
      to maximize the clinical utility in people suffering from MS and depression, we tailored
      mindfulness intervention on the needs of this specific population. We will apply a modified
      MBSR protocol integrated with body centered techniques from Sensorimotor Psychotherapy (SP;
      Ogden et al., 2006). SP was developed by Pat Ogden on the model of Ron Kurtz, a body
      psychotherapy built on mindfulness (Kurtz, 1990). Most of these points are already part of
      the MBSR model, but in this integration they are deepened more specifically to increase the
      clinical efficacy.

      We aim to evaluate whether a group-based Mindfulness Based Intervention can reduce depressive
      symptoms and improve the QoL of patients, also reducing correlated symptoms, like anxiety,
      fatigue and perceived stress and modifying the perception of the disease and how to deal with
      interpersonal relationships. Primary aim: to evaluate the efficacy of MBI on depressive
      symptoms and QoL of MS patients, compared to an active control intervention and to a usual
      care group, and to assess whether these expected benefits can be maintained at the 6-month
      follow-up.

      The secondary aim of the study is to assess whether after the Mindfulness Based Intervention
      there is an improvement in anxiety symptoms, in fatigue and in perceived stress; another
      secondary aim is to evaluate the efficacy of the intervention on the perception of the
      illness and whether participating in the MBI improve also the interpersonal relationship.
      Another secondary aim is to evaluate the efficacy of MBI on depression, QoL and related
      symptoms in caregivers.
    

Intervention name(s): Mindfulness; Psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The MBI is based on MBSR protocol but in order to maximize the clinical utility in people with MS suffering from depressive symptoms, we will tailor mindfulness intervention on the needs of this specific population. We will apply a modified MBSR protocol integrated with techniques from Sensorimotor Psychotherapy.
The MBI comprises an 8-week group program. Participants will took part in a 3 hour single weekly sessions, and there will be also an additional all-day session of 7 hours. Each session will cover specific exercises and topics within the context of mindfulness practice and training. Participants will be required to carry out daily 45-min homework assignments, which consist on mindfulness exercises and mindfulness applications in everyday life.; The control group is designed to control for the nonspecific elements of the MBI treatment. It will be based on a psycho-educational framework and will include some relaxation techniques. In each session is discussed a MS-related topic. Relaxation and gentle stretching exercises will be proposed at the end of each session. Homework and the material (photocopies, slides, etc.) discussed in group sessions is left to each participant to encourage participants to practice exercises between sessions.
This intervention will follow the same structure and weekly format of the MBI intervention. The only difference will be the absence of an all-day session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; depression; mindfulness