Objective: Multiple Sclerosis (MS) is a demyelinating autoimmune disease that imposes a significant emotional burden with heavy psychosocial consequences. Several studies have investigated the association between MS and mental disorders such as depression and anxiety, and recently researchers have focused also on Post-traumatic Stress Disorder (PTSD). This is the first study that investigates the usefulness of proposing a treatment for PTSD to patients with MS.Methods: A randomized controlled trial with patients with MS diagnosed with PTSD comparing Eye Movement Desensitization and Reprocessing (EMDR; n = 20) and Relaxation Therapy (RT; n = 22). The primary outcome measure was the proportion of participants that no longer meet PTSD diagnosis as measured with Clinician Administered PTSD Scale 6-months after the treatment.Results: The majority of patients were able to overcome their PTSD diagnosis after only 10 therapy sessions. EMDR treatment appears to be more effective than RT in reducing the proportion of patients with MS suffering from PTSD. Both treatments are effective in reducing PTSD severity, anxiety and depression symptoms, and to improve Quality of Life.Conclusion: Although our results can only be considered preliminary, this study suggests that it is essential that PTSD symptoms are detected and that brief and cost-effective interventions to reduce PTSD and associated psychological symptoms are offered to patients, in order to help them to reduce the psychological burden associated with their neurological condition.Trial registration: NCT01743664, https://clinicaltrials.gov/ct2/show/NCT01743664

Purpose: Mindfulness interventions have been shown to treat depressive symptoms and improve quality of life in patients with several chronic diseases, including multiple sclerosis, but to date most evaluation of the effectiveness of mindfulness interventions in multiple sclerosis have used patients receiving standard care as the control group. Hence we decided to evaluate the effectiveness of a group-based body-affective mindfulness intervention by comparing it with a psycho-educational intervention, by means of a randomized controlled clinical trial. The outcome variables (i.e., depression, anxiety, perceived stress, illness perception, fatigue and quality of life) were evaluated at the end of the interventions (T1) and after a further 6 months (T2).Methods: Of 90 multiple sclerosis patients with depressive symptoms (Beck Depression Inventory-II score greater than 13) who were randomized, 71 completed the intervention (mindfulness group n = 36; psycho-educational group n = 35). The data were analyzed with GLM repeated-measures ANOVA followed by pairwise comparisons.Results: Per-protocol analysis revealed a time by group interaction on Beck Depression Inventory-II score, with the mindfulness intervention producing a greater reduction in score than the psycho-educational intervention, both at T1 and at T2. Furthermore, the mindfulness intervention improved patients’ quality of life and illness perception at T1 relative to the baseline and these improvements were maintained at the follow-up assessment (T2). Lastly, both interventions were similarly effective in reducing anxiety and perceived stress; these reductions were maintained at T2. A whole-sample intention-to-treat (ITT) analysis broadly confirmed the effectiveness of the mindfulness intervention.Conclusion: In conclusion, these results provide methodologically robust evidence that in multiple sclerosis patients with depressive symptoms mindfulness interventions improve symptoms of depression and anxiety and perceived stress, modulate illness representation and enhance quality of life and that the benefits are maintained for at least 6 months.Trial registration: the study was registered in the ClinicalTrials.gov registry (NCT02611401).

BackgroundMultiple Sclerosis has a great impact on psychological functioning of patients and can be associated with various mental health disorders and symptoms. The most prevalent one is depression, which ranges from 15 to 47 %.Mindfulness Based Interventions are a relatively brief and cost-effective program that has been studied in patients with several chronic diseases and recently also in patients with Multiple Sclerosis. Mindfulness Based Interventions are based on the assumption that a non-judgmental awareness and acceptance of one’s moment-to-moment experience can have a positive effect on the adaptation to the disease, reducing the psychological burden and improving patients’ quality of life.Several studies concluded that Mindfulness Based Interventions can be beneficial in terms of improving both psychological and psychical aspects of Multiple Sclerosis, but none of them compared the intervention with an active control group. The primary objective of the study is to evaluate the efficacy of a group-based Mindfulness Based Intervention on depressive symptoms in patients with Multiple Sclerosis, as compared with an active control group.MethodsThe study design is a randomized controlled clinical trial. Eighty-eight patients with Multiple Sclerosis and depressive symptoms will be recruited and randomized to either Mindfulness Based Intervention or an active control group. The latter is designed to control for non-specific elements of the intervention and it comprises psycho-education and relaxation techniques. The primary outcome is the reduction of depressive symptoms as measured via the Beck Depressive Inventory-II. Secondary outcome measures are level of quality of life, anxiety, perceived stress, illness perception, fatigue and quality of interpersonal relationship. Outcomes will be assessed at baseline, after treatment and 6 months after the end of the treatment. Caregivers will participate in groups together with patients.DiscussionAs far as we know this trial will be the first randomized controlled trial testing the efficacy of group-based Mindfulness Based Intervention for patients with Multiple Sclerosis with a comparison with an active control group with a specific focus on depressive symptoms.Trial registrationNCT02611401.

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