A Psychosocial Intervention for Supporting Informal Caregivers of Older People with Alzheimer Disease: Protocol for the InnFamiglia Randomized Controlled Trial

Background Dementia is a neurodegenerative syndrome characterized by impaired cognitive functions associated with psychological and behavioral disorders. The informal caregiver has a central role in the life of the person with dementia. Committing a large part of the day to caring for the assisted person inevitably has an effect on the caregiver’s life. Objective The aim of this study is to analyze the impact of a psychosocial intervention dedicated to a group of informal caregivers of patients with Alzheimer disease. The intervention will be guided by a trained psychologist who will facilitate the participants’ expression of their emotional states, as compared to a traditional self-help group. Methods The intervention described in this paper was designed and developed for the project INNovazione sociale e tecnologica per le FAMIGLIE che assistono malati affetti da Alzheimer (InnFamiglia). The study is designed as a randomized controlled trial (RCT). The RCT includes an experimental group, in which the participants will undertake the psychosocial intervention, and a control group, where participants will receive support according to traditional self-help methodology. Interventions for both groups will last 4 months and will be comprised of 16 sessions. Results Participant recruitment, enrollment, and data collection began in 2021. Enrollment continued until September 2022, at which time the last group began the intervention. Data collection will be completed by December 2022, and data analysis will be completed by March 2023. The study findings will be published in peer-reviewed scientific journals and will be presented at scientific meetings. Summaries of the results will also be made available to investigators for dissemination within their clinics. Conclusions We hypothesize that the experimental group will be more effective in managing caregiver burden and coping strategies and that this will improve the perception of well-being, anxiety, and depression among caregivers. Our study aims to compare two groups receiving different interventions: a self-help group and a psychosocial group with elements of emotional support. This study may also give us more information about the most appropriate ways to support and help caregivers of people with dementia. International Registered Report Identifier (IRRID) DERR1-10.2196/37496