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Background While nonprofessional caregivers often experience a sense of fulfillment when they provide care, there is also a significant risk of emotional and physical burnout. Consequently, this can negatively affect both the caregiver and the person being cared for. Intervention programs can help empower nonprofessional caregivers of people with chronic diseases and develop solutions to decrease the physical and psychological consequences resulting from caregiving. However, most clinically tested intervention programs for nonprofessional caregivers require face-to-face training, and many caregivers encounter obstacles that hinder their participation in such programs. Consequently, it is necessary to design internet-based intervention programs for nonprofessional caregivers that address their needs and test the efficacy of the programs. Objective The aim of this study was to evaluate the effectiveness of a smartphone app–based intervention program to increase positive mental health for nonprofessional caregivers. Methods This study was a randomized controlled trial of 3 months’ duration. A total of 152 caregivers over 18 years of age with a minimum of 4 months’ experience as nonprofessional caregivers were recruited from primary health care institutions. Nonprofessional caregivers were randomized into two groups. In the intervention group, each caregiver installed a smartphone app and used it for 28 days. This app offered them daily activities that were based on 10 recommendations to promote positive mental health. The level of positive mental health, measured using the Positive Mental Health Questionnaire (PMHQ), and caregiver burden, measured using the 7-item short-form version of the Zarit Caregiver Burden Interview (ZBI-7), were the primary outcomes. Users’ satisfaction was also measured. Results In all, 113 caregivers completed the study. After the first month of the intervention, only one factor of the PMHQ, F1–Personal satisfaction, showed a significant difference between the groups, but it was not clinically relevant (0.96; P=.03). However, the intervention group obtained a higher mean change for the overall PMHQ score (mean change between groups: 1.40; P=.24). The results after the third month of the intervention showed an increment of PMHQ scores. The mean difference of change in the PMHQ score showed a significant difference between the groups (11.43; P<.001; d=0.82). Significant changes were reported in 5 of the 6 factors, especially F5–Problem solving and self-actualization (5.69; P<.001; d=0.71), F2–Prosocial attitude (2.47; P<.001; d=1.18), and F3–Self-control (0.76; P=.03; d=0.50). The results of the ZBI-7 showed a decrease in caregiver burden in the intervention group, although the results were inconclusive. Approximately 93.9% (46/49) of the app users indicated that they would recommend the app to other caregivers and 56.3% (27/49) agreed that an extension of the program’s duration would be beneficial. Conclusions The app-based intervention program analyzed in this study was effective in promoting positive mental health and decreasing the burden of caregivers and achieved a high range of user satisfaction. This study provides evidence that mobile phone app–based intervention programs may be useful tools for increasing nonprofessional caregivers’ well-being. The assessment of the effectiveness of intervention programs through clinical trials should be a focus to promote internet-based programs in health policies. Trial Registration ISRCTN Registry ISRCTN14818443; http://www.isrctn.com/ISRCTN14818443 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7264-5

Background To assess the effectiveness of a smartphone app-based intervention compared to a regular intervention of caregivers in primary health care institutions. The intervention is aimed at increasing positive mental health and decreasing caregiver’s burden. Methods/design Randomized and controlled trial with an experimental group and a control group. Subjects: 108 caregivers over 18, with a minimum of 4 months of experience as caregivers. Description of the intervention: an intervention with a smartphone app ( n = 54) or a regular intervention for caregivers ( n = 54). Each caregiver installs a smartphone app and uses it for 28 days. This app offers them a daily activity (Monday-Friday). These activities are related to the Decalogue of Positive Mental Health, which was designed ad hoc by a group of experts. The outcomes will be the score of caregiver burden, the positive mental health and participant satisfaction. These results will be assessed after the first, third and sixth month. Discussion The results of this study will offer evidence of the effectiveness of an intervention using a free smartphone app. If its effectiveness is proven and the results are acceptable, this could lead to a rethinking of the intervention offered to caregivers in primary care. Trial registration Clinical Register ISRCTN14818443 (date: 24/05/2019).

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