A group resilience training program for people with multiple sclerosis: Study protocol of a multi-centre cluster-randomized controlled trial (multi-READY for MS).

INTRODUCTION: REsilience and Activities for every DaY (READY) is an Acceptance and Commitment Therapy-based group resilience-training program that has preliminary empirical support in promoting quality of life and other psychosocial outcomes in people with multiple sclerosis (PwMS). Consistent with the Medical Research Council framework for developing and evaluating complex interventions, we conducted a pilot randomized controlled trial (RCT), followed by a phase III RCT. The present paper describes the phase III RCT protocol. METHODS AND ANALYSIS: This is a multi-centre cluster RCT comparing READY with a group relaxation program (1:1 ratio) in 240 PwMS from eight centres in Italy (trial registration: isrctn.org Identifier: ISRCTN67194859). Both interventions are composed of 7 weekly sessions plus a booster session five weeks later. Resilience (primary outcome), mood, health-related quality of life, well-being and psychological flexibility will be assessed at baseline, after the booster session, and at three and six month follow-ups. If face-to-face group meetings are interrupted because of COVID-19 related-issues, participants will be invited to complete their intervention via teleconferencing. Relevant COVID-19 information will be collected and the COVID-19 Peritraumatic Distress scale will be administered (ancillary study) at baseline and 3-month follow-up. Analysis will be by intention-to-treat to show superiority of READY over relaxation. Longitudinal changes will be compared between the two arms using repeated-measures, hierarchical generalized linear mixed models. CONCLUSION: It is expected that his study will contribute to the body of evidence on the efficacy and effectiveness of READY by comparing it with an active group intervention in frontline MS rehabilitation and clinical settings. Results will be disseminated in peer-reviewed journals and at other relevant conferences.

Treatment with Delta-9-tetrahydrocannabinol/cannabidiol in Multiple Sclerosis: Influence on the Autonomy Profile according to the International Classification of Functioning, Disability and Health.

Multiple sclerosis (MS) is the most common cause of non-traumatic neurological disability in young adults. It has effects at different levels: physical, emotional, psychological, cognitive and social, with a great variety of signs and symptoms. In particular, spasticity contributes to reducing the motor performance of patients with MS, causing pain, reduction in distance walked and limitations in social life. We present the case of a 39-year-old woman with MS. She was treated with delta-9-tetrahydrocannabinol/cannabidiol and the outcome was assessed with the International Classification of Functioning Disability and Health core set framework. LEARNING POINTS: The clinical presentation of multiple sclerosis (MS) is heterogeneous but very often lower limb spasticity leads to severe disability.The use of nabiximols improved spasticity control and motor performance in walking, and also had a larger effect in improving activity and participation in personal relationships.Appropriate assessment of MS cases, through the ICF framework, may demonstrate further effects of nabiximols on patient capacity and performance.

Increased body mass and depressive symptomatology are associated with hypercholesterolemia, among elderly individuals; results from the MEDIS study.

BACKGROUND: Hypercholesterolemia is one of the most important factors causing cardiovascular disease (CVD). The aim of the present work was to evaluate the relationships between socio-demographic, clinical, lifestyle and depression status and the presence of hypercholesterolemia, among elderly individuals without known CVD. METHODS: During 2005-2007, 1190 elderly (aged 65 to 100 years) men and women (from Cyprus, Mitilini, Samothraki, Cephalonia, Crete, Lemnos, Corfu and Zakynthos) were enrolled. Socio-demographic, clinical and lifestyle factors were assessed through standard procedures. Symptoms of depression were evaluated using the short-form of the Geriatric Depression Scale (GDS, range 0-15). Dietary habits were assessed through a semi-quantitative food frequency questionnaire. Hypercholesterolemia was defined as total serum cholesterol > 200 mg/dL or use of lipids lowering medication. RESULTS: 44.6% of males and 61.9% of females had hypercholesterolemia (p < 0.001). Only, 63% of hypercholesterolemic participants were under special diet or pharmaceutical treatment. Hypercholisterolemic individuals had higher prevalence of obesity (43% vs. 25%), hypertension (76% vs. 57%) and diabetes (25% vs. 17%) compared with normal participants (p < 0.001). Furthermore, hypercholisterolemic participants showed higher depression levels (p = 0.002). After adjusting for various confounders, GDS score and BMI correlated with 13% (95%CI 0.98-1.30) and 14% (95%CI 0.99-1.31) higher likelihood of having hypercholesterolemia. CONCLUSION: A considerable proportion of our elderly sample had hypercholesterolemia, while 1/3 of them were untreated. Furthermore, presence of hypercholesterolemia was correlated with depressive symptomatology and increased BMI.

Long-term, moderate coffee consumption is associated with lower prevalence of diabetes mellitus among elderly non-tea drinkers from the Mediterranean Islands (MEDIS Study).

BACKGROUND: We evaluated the association between coffee drinking and the prevalence of type 2 diabetes mellitus in elderly people from the Mediterranean islands. METHODS: During 2005-2007, 500 men and 437 women (aged 65 to 100 years) from the islands of Cyprus (n = 300), Mitilini (n = 142), Samothraki (n = 100), Cephalonia (n = 104), Corfu (n = 160) and Crete (n = 131) participated in the survey. Cardiovascular disease (CVD) risk factors (i.e. hypertension, diabetes, hypercholesterolemia and obesity), as well as behavioral, lifestyle and dietary characteristics were assessed using face-to-face interviews and standard procedures. Among various factors, fasting blood glucose was measured and prevalence of type 2 diabetes mellitus was estimated, according to the established American Diabetes Association (ADA) criteria, while all participants were asked about the frequency of any type of coffee consumption over the last year. RESULTS: Coffee drinking was reported by 84% of the participants, the majority of whom drank boiled coffee. The participants reported that they had consumed coffee for at least 30 years of their life. Data analysis adjusted for various potential confounders, revealed that, compared to non-consumption, the multi-adjusted odds ratio for having diabetes was 0.47 (95%, CI 0.32 to 0.69) for 1-2 cups/day, while it was 1.05 (95%, CI 0.70 to 1.55) for >3 cups/day, after adjusting for various potential confounders. The association of coffee drinking with diabetes was significant only among non-tea drinkers. Increased coffee intake was not associated with diabetes prevalence. CONCLUSION: The data presented suggest that moderate coffee drinking is associated with a lower likelihood of having diabetes, after adjusting for various potential confounders.