T1-REDEEM: A Randomized Controlled Trial to Reduce Diabetes Distress Among Adults With Type 1 Diabetes.

Abstract

To compare the effectiveness of two interventions to reduce diabetes distress (DD) and improve glycemic control among adults with type 1 diabetes (T1D). Individuals with T1D (<i>n</i> = 301) with elevated DD and HbA_1c were recruited from multiple settings and randomly assigned to OnTrack, an emotion-focused intervention, or to KnowIt, an educational/behavioral intervention. Each group attended a full-day workshop plus four online meetings over 3 months. Assessments occurred at baseline and 3 and 9 months. Primary and secondary outcomes were change in DD and change in HbA_1c, respectively. With 12% attrition, both groups demonstrated dramatic reductions in DD (effect size <i>d</i> = 1.06; 78.4% demonstrated a reduction of at least one minimal clinically important difference). There were, however, no significant differences in DD reduction between OnTrack and KnowIt. Moderator analyses indicated that OnTrack provided greater DD reduction to those with initially poorer cognitive or emotion regulation skills, higher baseline DD, or greater initial diabetes knowledge than those in KnowIt. Significant but modest reductions in HbA_1c occurred with no between-group differences. Change in DD was modestly associated with change in HbA_1c (<i>r</i> = 0.14, <i>P</i> = 0.01), with no significant between-group differences. DD can be successfully reduced among distressed individuals with T1D with elevated HbA_1c using both education/behavioral and emotion-focused approaches. Reductions in DD are only modestly associated with reductions in HbA_1c. These findings point to the importance of tailoring interventions to address affective, knowledge, and cognitive skills when intervening to reduce DD and improve glycemic control.