Teaching Adolescents with type 1 Diabetes Self-compassion (TADS) to reduce diabetes distress: study protocol of a randomized controlled trial (Preprint)

Adolescents living with type 1 diabetes (T1D) often experience diabetes distress (DD), a construct distinct from depression or anxiety that refers to the negative emotions that arise from living with and managing diabetes. Self-compassion, which involves being open to one's own suffering and treating oneself with the same care one would show to loved ones, is associated with better psychological and clinical outcomes among individuals with T1D. Self-compassion is a skill that can be taught, and therefore represents an opportunity for intervention.The overall aim of the study is to assess the effectiveness of a virtual mindful self-compassion for teens (MSC-T) intervention on improving DD, anxiety, depression, diabetes-related disordered eating, and suicide ideation experienced by youth (age 12-17 years) with T1D compared to a wait-list control group (standard of care). We will also explore a) if the effect of the MSC-T intervention changes over time, b) if the MSC-T intervention has a positive impact on measures of glycemic control, and c) if the effect of the MSC-T intervention differs based on self-reported gender.This study will be a single-centre, parallel group randomized controlled trial of 140 adolescents with T1D followed for 12 months. Participants will be randomly allocated (using hidden allocation) in a 1:1 ratio to either the MSC-T intervention or the wait-list control group. Our primary outcome is DD, as measured by the Problem Areas in Diabetes - Teen version (PAID-T) at 3 months. Secondary outcomes, assessed at 3 and 12 months, include anxiety (Generalized Anxiety 7-item scale, GAD-7), depression (Patient Health Questionnaire, PHQ-9), diabetes-related disordered eating (Diabetes Eating Problem Survey revised version, DEPS-R), and suicidal ideation (using one question from the PHQ-9).Study recruitment began in October 2022 and was completed in March 2023. Data collection will be ongoing until March 2024. The first results are expected in June 2024.This study will be the first randomized trial to assess the effectiveness of the virtually delivered MSC-T intervention on adolescents with T1D. Given that adolescence is a period where individuals are typically required to assume more responsibility for their diabetes care, providing adolescents with the tools they need to better manage the stress that often accompanies T1D management is paramount.NCT05463874.