THR1VE!: Randomized controlled trial to reduce diabetes distress in adolescents with type 1 diabetes.

Abstract

Aims: To evaluate the effects of a positive psychology intervention to treat diabetes distress (DD) and improve glycaemic outcomes among adolescents with type 1 diabetes.

Methods: Adolescents ages 13-17 with elevated DD and their caregivers from 2 sites (n = 198 dyads) were randomized to receive enhanced usual care (Diabetes Education) or a Diabetes Education + Positive Affect intervention, delivered via automated text messages. Psychosocial and glycaemic data were collected at baseline, 3 months, 6 months and 12 months. The primary outcomes were changes in diabetes distress (DD) and HbA1c over 12 months.

Results: Adolescents demonstrated high levels of engagement in the trial; overall response to text messages was 91%, and retention was 90% over 12 months. Adolescents in both groups reported reductions in DD from baseline to 12 months (effect size d = 0.40), and they were significantly more likely to move from clinically relevant levels into the normal range of DD than to report increased DD (OR = 2.2, p = 0.002). Adolescents' HbA1c was stable over 12 months. We did not observe significant differences in outcomes between groups. Improvement in DD was associated with decreased HbA1c over time (β = 1.89, p = 0.02).

Conclusions: There was no significant intervention effect on DD or HbA1c. Adolescents in both the Diabetes Education and Diabetes Education + Positive Affect arms reported reduced DD over 12 months. Future studies are needed to determine how to employ the least burdensome, engaging intervention for distressed adolescents.