Depression and loneliness among Sub-Saharan immigrants living in the greater Paris area: results from the MAKASI empowerment stepped wedge cluster randomised controlled trial.

Purpose: The MAKASI intervention aimed to empower Sub-Saharan African immigrants living in precarious situations in the Paris metropolitan area. Because there are factors specifically related to immigration that may increase the risk for common mental disorders, the present study aimed to examine participants' levels of depression and loneliness and analyze the effect of the intervention on depression and loneliness. Methods: The MAKASI study was designed as a stepped wedge cluster randomized trial. Study participants were recruited through an outreach program led by a nongovernmental organization and randomly assigned to two clusters, with an intervention delay of 3 months between them. Participants were assessed for 6 months after inclusion and the effect of the intervention on depression and loneliness was assessed using generalized linear mixed models. The study was conducted from 2018 to 2021 and took in consideration whether being interviewed during one of the Covid-19 confinement had an effect on the results. Results: Between 2018 and 2021 a total of 821 subjects participated in the Makasi study. High levels of depression and loneliness were found in the study population. We found no effect of the intervention on depression [95% CI 0.77 to 2.40]. Similarly, no effect of the intervention was found on loneliness [95% CI 0.87 to 2.54]. Conclusions: The intervention tested did not appear to improve the level of depression and loneliness among participants. However, the high prevalence of mental and emotional problems in the study population suggests a public health crisis among immigrants in the greater Paris area. Clinical Trial Registration Number: Trial registration Clinicaltrials.gov, NCT04468724 (July 13, 2020). [ABSTRACT FROM AUTHOR]