eMSQOL-29: Prospective validation of the abbreviated, electronic version of MSQOL-54.

BACKGROUND: We recently devised a shortened version of the 54-item Multiple Sclerosis Quality of Life (MSQOL-54) in paper (MSQOL-29, consisting of 25 items forming 7 subscales and 4 single items, and one filter question for 3 'sexual function' items) and electronic format (eMSQOL-29). OBJECTIVES: To prospectively assess eMSQOL-29 psychometric properties, acceptability/equivalence versus MSQOL-29. METHODS: Multiple sclerosis (MS) patients ( n = 623; Expanded Disability Status Scale (EDSS) range 0.0-9.0) completed eMSQOL-29, Hospital Anxiety and Depression Scale, Functional Assessment of MS (FAMS), European Quality of life Five Dimensions-3L, and received EDSS and Symbol Digit Modalities Test (SDMT). Equivalence versus MSQOL-29 was assessed in 242 patients (randomized cross-over design). RESULTS: 'Sexual function' items were filtered out by 273 patients (47%). No multi-item scale had floor effect, while five had ceiling effect. Cronbach's alpha range was 0.88-0.90. Confirmatory factor analysis showed good overall fit and the two-factor solution for composite scores was confirmed. Criterion validity was sub-optimal for 'cognitive function' (vs SDMT, r = 0.25) and 'social function' (vs FAMS social function, r = 0.38). eMSQOL-29 equivalence was confirmed and its acceptability was good. CONCLUSION: eMSQOL-29 showed good internal consistency, factor structure and no floor effect, while most subscales had some ceiling effect. Criterion validity was sub-optimal for two subscales. Equivalence and acceptability were good.

Prevalence of Posttraumatic Stress Disorder in Patients With Multiple Sclerosis.

Chronic and life-threatening illnesses, such as multiple sclerosis (MS), have been identified as significant stressors potentially triggering posttraumatic stress disorder (PTSD). The study aims to investigate the prevalence of PTSD according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria in a large sample of patients with MS. A total of 988 patients with MS were screened with the Impact of Event Scale-Revised, and then assessed with the PTSD module of the Structured Clinical Interview for DSM-IV and with the Clinician-Administered PTSD Scale to confirm PTSD diagnosis. Posttraumatic symptoms were reported by 25.5% of the sample. A confirmed diagnosis of PTSD was found in 5.7% of patients, but prevalence could reach 8.5%, including also dropout patients. Further studies are needed to evaluate if adjustment disorder could better encompass the frequently encountered subthreshold posttraumatic stress symptoms and how clinicians can deal with these symptoms with appropriate interventions.

The efficacy of a Mindfulness Based Intervention for depressive symptoms in patients with Multiple Sclerosis and their caregivers: study protocol for a randomized controlled clinical trial.

BACKGROUND: Multiple 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. METHODS: The 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. DISCUSSION: As 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 REGISTRATION: NCT02611401.

The Effectiveness of a Body-Affective Mindfulness Intervention for Multiple Sclerosis Patients with Depressive Symptoms: A Randomized Controlled Clinical Trial.

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).

Decline of Neuropsychological Abilities in a Large Sample of Patients with Multiple Sclerosis: A Two-Year Longitudinal Study.

OBJECTIVE: In this longitudinal study, we monitored two large groups of multiple sclerosis (MS) patients and healthy controls (HC) for 2 years, with the aim of comparing their neuropsychological profile over time. METHOD: Three hundred and twenty-two patients with MS and 303 HC were administered the Brief Repeatable Battery of Neuropsychological tests (BRB-N); neuropsychiatric measures were also administered. Two follow-ups were scheduled at 1 and 2 years, respectively. RESULTS: A linear mixed model (LMM) with random intercept was run by considering participants' performance on each test of the BRB-N at the three assessment points (baseline and follow-ups) as the within-subjects variable, and group (patients and controls) as the between-subjects factor. The interaction term was statistically significant for the tests: Symbol Digit Modalities test (SDMT) (p = 0.044), Paced Auditory Serial Addition test (PASAT) (p = 0.011) and Word List Generation (WLG) (p < 0.001), whereas for the PASAT-3 approached statistical significance (p = 0.05). In addition, a LMM with random intercept was also run by identifying three groups (controls, relapsing-remitting course of MS (i.e. RR-MS), and prog-MS). The interaction term was statistically significant for: PASAT-3 (p = 0.017), PASAT-2 (p = 0.0026), and WLG (p = 0.0022). CONCLUSIONS: Our results corroborate on a very large scale evidence that the abilities tapped by the tasks SDMT, PASAT and WLG are particularly sensitive to MS, and further extend this issue by showing that these abilities are likely to be more sensitive than others to the progression of the disease, as compared to HC.

Presence and significant determinants of cognitive impairment in a large sample of patients with multiple sclerosis.

OBJECTIVES: To investigate the presence and the nature of cognitive impairment in a large sample of patients with Multiple Sclerosis (MS), and to identify clinical and demographic determinants of cognitive impairment in MS. METHODS: 303 patients with MS and 279 healthy controls were administered the Brief Repeatable Battery of Neuropsychological tests (BRB-N); measures of pre-morbid verbal competence and neuropsychiatric measures were also administered. RESULTS: Patients and healthy controls were matched for age, gender, education and pre-morbid verbal Intelligence Quotient. Patients presenting with cognitive impairment were 108/303 (35.6%). In the overall group of participants, the significant predictors of the most sensitive BRB-N scores were: presence of MS, age, education, and Vocabulary. The significant predictors when considering MS patients only were: course of MS, age, education, vocabulary, and depression. Using logistic regression analyses, significant determinants of the presence of cognitive impairment in relapsing-remitting MS patients were: duration of illness (OR = 1.053, 95% CI = 1.010-1.097, p = 0.015), Expanded Disability Status Scale score (OR = 1.247, 95% CI = 1.024-1.517, p = 0.028), and vocabulary (OR = 0.960, 95% CI = 0.936-0.984, p = 0.001), while in the smaller group of progressive MS patients these predictors did not play a significant role in determining the cognitive outcome. CONCLUSIONS: Our results corroborate the evidence about the presence and the nature of cognitive impairment in a large sample of patients with MS. Furthermore, our findings identify significant clinical and demographic determinants of cognitive impairment in a large sample of MS patients for the first time. Implications for further research and clinical practice were discussed.