Evaluation of a novel therapeutic education programme for people with alcohol use disorder in France: a mixed-methods intervention study protocol (ETHER)

Background ETHER (“Education THEérapeutique pour la Réduction des dommages en alcoologie” or Therapeutic education for alcohol-related harm reduction) is a multicentre community-based mixed-methods study, which aims to evaluate the effectiveness of the innovative therapeutic patient education (TPE) programme ‘Choizitaconso’ in a sample of French people with alcohol use disorder (people with AUD). Choizitaconso teaches people with AUD psychosocial skills to help them (re)establish controlled drinking and reduce alcohol-related harms. Recruitment started in October 2019. We present here the protocol of the ETHER study. Methods ETHER’s quantitative component involves a 6-month controlled intervention study which evaluates Choizitaconso’s effectiveness by comparing 30 people with AUD following the programme with a control group of 60 people with AUD not enrolled in it, using a questionnaire co-constructed by the research team and members of the people with AUD community. Thirty-four alcohol-related harms are assessed and summed to provide an individual measure of the ‘harm burden’ from consuming alcohol (primary outcome). Secondary outcomes are anticipated and internalized stigma, alcohol consumption measures, craving for alcohol, coping strategies, health-related quality of life, self-confidence to control or abstain from drinking, treatment self-regulation, anxiety and depressive symptoms, alcohol-related neuropsychological impairments, and capabilities (a measure of wellbeing in adults). Data will be collected in face-to-face and phone-based interviews at enrolment and 6 months later. Linear regression models will be used to assess the impact of the TPE programme on changes in the primary and secondary outcomes, while adjusting for other correlates and confounders. The study’s qualitative component comprises semi-structured interviews with 16 people with AUD who have already completed the TPE programme at least 6 months before the interview. Qualitative interviews will be analysed using thematic analysis. Results and conclusions ETHER is the first evaluation study of an innovative TPE programme specifically designed to reduce alcohol-related harms and reach controlled drinking in France. The involvement of the people with AUD community in selecting which experienced and perceived alcohol-related harms to measure ensures that ETHER will provide healthcare staff and researchers with a relevant set of harm reduction criteria for use in future research. Finally, ETHER will provide scientific justification for implementing novel alcohol-related harm reduction approaches and champion controlled drinking as a therapeutic goal. Trial registration ClinicalTrials.gov, NCT03954054. Registered 17 May 2019—Prospectively registered, https://clinicaltrials.gov/ct2/show/NCT03954054?cond=alcohol&cntry=FR&city=Marseille&draw=1&rank=1.

The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER): Study Design and Protocol

Background: The SINgapore GERiatric intervention study to reduce cognitive decline and physical frailty (SINGER) randomised controlled trial (RCT) uses a multidomain lifestyle interventions approach, shown to be effective by the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) trial, to delay cognitive decline. Objective: To investigate the efficacy and safety of the SINGER multidomain lifestyle interventions in older adults at risk for dementia to delay cognitive decline. Participants: 1200 participants between 60-77 years old, with Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) dementia risk score ≥6, fulfilling at least one of the following LIBRA index for diet, cognitive activity, physical activity and a Montreal Cognitive Assessment (MoCA) score ≥18, ≤27 points, will be recruited across Singapore. Methods: SINGER is a 2-year multi-site RCT consisting of multidomain interventions: dietary advice, exercise, cognitive training, and vascular risk factors management. Participants will be randomised into either the Self-Guided Intervention (SGI; general lifestyle and health information and resources) or Structured Lifestyle Intervention (SLI) group. The SLI comprises diet training (6 group and 3 individual sessions over 12 months); exercise (supervised: 1-hour twice weekly for 6 months, unsupervised: 2-3/week for the rest of the study duration); cognitive sessions (15-30 minutes/session, 3/week for 6 months, together with 10 workshops in 24 months). Vascular management takes place every 3-6 months or otherwise as specified by study physicians. The primary outcome is global cognition measured using the modified Neuropsychological Battery assessing performance in various domains, such as episodic memory, executive function and processing speed. Secondary outcome measures include: domain-specific cognition and function, imaging evidence of brain and retinal changes, incidence and progression of chronic diseases, blood biomarkers, quality of life, mental health and cost-benefit analysis. Conclusions: SINGER is part of the Worldwide-FINGERS international network, which is at the forefront of harmonizing approaches to effective non-pharmacological interventions in delaying cognitive decline in older adults at risk of dementia. By establishing the efficacy of multidomain interventions in preventing cognitive decline, SINGER aims to implement the findings into public health and clinical practices by informing policy makers, and guiding the design of community- and individual-level health promotion initiatives.

The Role of Executive Function in the Effectiveness of Multi-Component Interventions Targeting Physical Activity Behavior in Office Workers

A knowledge gap remains in understanding how to improve the intervention effectiveness in office workers targeting physically active (PA) behavior. We aim to identify the modifying effect of executive function (EF) on the intervention effectiveness targeting PA-behaviors, and to verify whether the observed effect varies by Job Demand Control (JDC) categories. This workplace-based intervention study included 245 participants who were randomized into a control group and two intervention arms—promoting physical activity (iPA) group or reducing sedentary behavior (iSED) group. The interventions were conducted through counselling-based cognitive behavioral therapy and team activities over 6 months. PA-behaviors were measured by an accelerometer. EF was assessed by the Trail Making Test-B, Stroop, and n-back test. The JDC categories were measured by the demand control questionnaire. Higher EF level at baseline was significantly associated with the intervention effect on increased sleep time (β-coefficient: 3.33, p = 0.003) and decreased sedentary time (−2.76, p = 0.049) in the iSED-group. Participants with active jobs (high job demands, high control) presented significantly increased light-intensity PA in the iSED-group in comparison to the control group. Among participants with a high level of EF and active jobs, relative to the control group, the iPA-group showed a substantial increase in light-intensity PA (1.58, p = 0.036) and the iSED-group showed a tendency of reducing sedentary behavior (−5.35, p = 0.054). The findings suggest that office workers with a high EF and active jobs may benefit most from an intervention study targeting PA-behaviors.