Type 1 diabetes and the challenges of emotional support in crisis situations: results from a randomized clinical trial of a multidisciplinary teleintervention

Abstract

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.

Figure 1

Flow diagram of the study.

Figure 2

Participants with positive screening for mental health disorders based on cutoff values of the questionnaires. For the evaluation of emotional disorders, a score greater than or equal to 7 on SRQ 20 is considered positive. Diabetes-related emotional distress is considered when the B-PAID score is greater than or equal to 40. The presence of positive screening for an eating disorder is considered when the EAT 26 score is greater than or equal to 20. A positive screening for sleep disorder is considered when a score greater than or equal to 31 is present in the MSQ. *P = 0.04 for comparison between groups after the intervention.