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The association between type 1 diabetes and mental health disorders could be exacerbated in a stressful environment. This study aimed to evaluate the effectiveness of a teleguided intervention on emotional disorders in patients with type 1 diabetes during the COVID-19 outbreak. An open-label clinical trial was performed during the social distancing period in the COVID-19 outbreak in Brazil. Individuals with type 1 diabetes aged ≥ 18 years were randomized to receive a teleguided multidisciplinary intervention or the usual care plus an educational website access. The primary outcome was a positive screening for emotional disorders (Self Report Questionnaire 20) after a 16-week intervention. Secondary outcomes included evaluation of patients’ perceptions of pandemic-related changes, diabetes-related emotional distress, eating disorders, and sleep disorders. Data were analyzed with the intent‐to‐treat principle. Fifty-eight individuals (mean age, 43.8 ± 13.6 years) were included (intervention group, n = 29; control group, n = 29). The primary outcome was not different between the groups. The intervention group felt more supported in their diabetes care during the social distancing period (82.8% vs. 48.3% in the control group, P < 0.01). Both groups reported a similar self-perceived worsening of physical activity habits and mental health during the outbreak. There was no benefit to using the telehealth strategy proposed for emotional disorders in patients with type 1 diabetes during the COVID-19 outbreak. Further studies are needed to determine the impact on metabolic parameters and to understand why it is so difficult to emotionally support these patients.Trail Registration: ClinicalTrials.gov (NCT04344210), 14/04/2020.
The association between type 1 diabetes and mental health disorders could be exacerbated in a stressful environment. This study aimed to evaluate the effectiveness of a teleguided intervention on emotional disorders in patients with type 1 diabetes during the COVID-19 outbreak. An open-label clinical trial was performed during the social distancing period in the COVID-19 outbreak in Brazil. Individuals with type 1 diabetes aged ≥ 18 years were randomized to receive a teleguided multidisciplinary intervention or the usual care plus an educational website access. The primary outcome was a positive screening for emotional disorders (Self Report Questionnaire 20) after a 16-week intervention. Secondary outcomes included evaluation of patients’ perceptions of pandemic-related changes, diabetes-related emotional distress, eating disorders, and sleep disorders. Data were analyzed with the intent‐to‐treat principle. Fifty-eight individuals (mean age, 43.8 ± 13.6 years) were included (intervention group, n = 29; control group, n = 29). The primary outcome was not different between the groups. The intervention group felt more supported in their diabetes care during the social distancing period (82.8% vs. 48.3% in the control group, P < 0.01). Both groups reported a similar self-perceived worsening of physical activity habits and mental health during the outbreak. There was no benefit to using the telehealth strategy proposed for emotional disorders in patients with type 1 diabetes during the COVID-19 outbreak. Further studies are needed to determine the impact on metabolic parameters and to understand why it is so difficult to emotionally support these patients.Trail Registration: ClinicalTrials.gov (NCT04344210), 14/04/2020.
The association between type 1 diabetes and mental health disorders could be exacerbated in a stressful environment. This study aimed to evaluate the feasibility of a teleguided intervention on emotional disorders in patients with type 1 diabetes during the COVID-19 outbreak. This study was performed during the social distancing period in the COVID-19 outbreak in Brazil. Individuals with type 1 diabetes aged ≥ 18 years were selected to receive a teleguided multidisciplinary intervention or the usual care plus an educational website access. The proposed intervention aimed addressing aspects of mental health, diabetes care and lifestyle habits during the pandemic. The feasibility outcome included the assessment of recruitment capability and adherence to the proposed intervention. Moreover, we evaluated the presence of positive screening for emotional disorders (Self Report Questionnaire 20) after a 16-week intervention, patients’ perceptions of pandemic-related changes, diabetes-related emotional distress, eating disorders, and sleep disorders. Data were analyzed with the intent‐to‐treat principle. Fifty-eight individuals (mean age, 43.8 ± 13.6 years) were included (intervention group, n = 29; control group, n = 29). At the end of the study, a total of 5 participants withdrew from the study in the intervention group compared to only 1 in the control group. Participants who dropout from the study had similar mean age, sex and income to those who remained in the study. The analysis of mental health disorders was not different between the groups at the follow up: a positive screening result was found in 48.3% and 34.5% of participants in the intervention and control groups, respectively (P = 0.29). The intervention group felt more supported in their diabetes care during the social distancing period (82.8% vs. 48.3% in the control group, P < 0.01). Our study identified a disproportionate higher number of withdrawals in the intervention group when compared to the control group. This difference may have compromised the power of the study for the proposed assessments and should be reevaluated in future studies.Trial registration: ClinicalTrials.gov (NCT04344210). Date of registration: 14/04/2020.
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