IntroductionInformal caregivers play a major role in the support and maintenance of community patients with severe psychiatric disorders. A pilot study showed that an individualised brief intervention such as the Ensemble programme leads to significant improvements in psychological health state and optimism.Methods and analysisThis randomised controlled trial aims to compare the efficacy of using Ensemble in improving informal caregivers’ psychological health states and the ability to play an active role in their situations with that of support as usual. Improvements on the psychological health global index will be measured three times (T0-pre, T1-post and T3 2 months follow) with standardised questionnaires (the Global Severity Index of Brief Inventory Symptoms, the Life Orientation Test-Revised, the 36-item Medical Outcome Study Short-Form Health Survey and the French Zarit Burden Interview). Differences between groups in post-test and pretest values will be examined using an analysis of covariance for each outcome variable. The severity of illness measured by the Social and Occupational Functioning Assessment Scale will also be collected at T0 and T2 to compare eventual patient improvements. At the end of the programme, the experiences of the 20 patients participating in the Ensemble programme will be evaluated qualitatively.Ethics and disseminationThe research protocol received full authorisation from the Human Research Ethics Committee of the Vaud state, Switzerland. The principal paper will concern the results of the experimental design used to test the Ensemble programme. The research team will prioritise open access publications.Trial registration numberNCT04020497

Informal caregivers are overlooked, healthcare actors. They are at particular risk of distress and suffer from poor mental health. This study aimed to investigate the perceived stress and modulating factors during the first COVID-19 lockdown in Europe, regardless of the illness that care recipients suffer from. Sociodemographic data, coping resources, and perceived stress level using the Perceived Stress Scale (PSS-10) questionnaire were assessed using a web-based survey in Switzerland, France, and Belgium with 232 informal caregivers. Mediation analyses were used to identify the factors that modulate stress. Higher perceived stress among informal caregivers was associated with a younger age for the care recipient, family relationship with the care recipient, cohabitation, and female sex of the informal caregiver. These associations were partially mediated by the fear of getting ill (age, cohabitation), the conviction that lockdowns had a negative impact on health (age, kinship), and the perceived deterioration of the care recipient’s health (gender). The fear of losing the ability to cope with caregiving tasks due to an illness (COVID-19 and/or other) and the negative impact of the lockdown on care recipients’ health, particularly on the mental health of young care recipients, increased the stress of informal caregivers. Our results emphasize the importance of informal caregiving support to prevent heightened stress in lockdown conditions, regardless of care recipient illness or kinship.

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