A randomized clinical trial aimed at preventing poor psychosocial and glycemic outcomes in teens with type 1 diabetes (T1D)

Abstract

Adolescents with type 1 diabetes have an increased risk for a variety of emotional and behavioral challenges as well as negative diabetes outcomes. This study was designed to compare the effectiveness of a depression-prevention, resilience promotion program with an advanced diabetes education program. Each program consisted of 9 group-based sessions. There were 264 adolescents enrolled in this multi-site randomized clinical trial. The primary outcomes were depressive symptoms and glycemic control; secondary outcomes included resilience skills, diabetes management and adherence, and diabetes-specific distress. The goal of the present paper is to describe the study design, the intervention, and the baseline characteristics of the sample. Preliminary data suggests that enrollment, randomization and retention were successful. Longitudinal follow-up and examination of mechanisms of action as they relate to psychosocial and glycemic outcomes will be explored in the future.

Introduction

Adolescents with type 1 diabetes (T1D) must balance a complex daily treatment regimen while also facing the emotional, social and academic demands of this developmental period. Not surprisingly, adolescents are at increased risk for anxiety and depressive symptoms [1], [2], [3], [4], [5], poor coping and problem-solving skills [6], [7], poor regimen adherence [8], [9], and negative diabetes-specific health outcomes [10], [11], [12]. The mental and physical health risks of T1D add to its already staggering economic burden; the annual cost of diabetes in the United States for direct medical care exceeds $176 billion (a 41% increase from estimates in 2007) [13] and individuals with diabetes have twice the healthcare costs of their peers without diabetes [13]. The economic burden for individuals with T1D is greater than for those with T2D [14], [15]. The risk of depressive symptoms in individuals with diabetes is much higher than in the general population, with rates ranging between 13 and 33% [16], [17], [18], [19], yet only 4% of youth with depressive symptoms receive mental health services [19]. Moreover, individuals with both depression and diabetes incur 4.5 times the health care costs as those with diabetes alone [17], [18], [20].

A handful of psychological interventions targeting adolescents with type 1 diabetes' poor behavioral and emotional functioning demonstrate beneficial effects on disease management and psychosocial outcomes [21], [22], [23], [24]. These interventions also demonstrate prolonged benefit in preventing the development of later psychosocial difficulties. However, no prevention programs exist that equip adolescents with the behavioral skills and cognitive strategies shown to reduce depression and typical correlates of depressive and distress symptoms (e.g., suboptimal diabetes management and glycemic control). Most clinical interventions aimed at preventing depression have been developed for healthy youth [25], and none have been adapted for adolescents with T1D. The Penn Resilience Program (PRP) [26], [27], [28], [29], [30], [31], [32], [33] is a depression-prevention program that has been widely studied, both as a universal and as a selective intervention [27], [28]. PRP interventions have been led by both professionals and members of the lay community [26], [27] and it has been implemented in schools and in community mental health centers [26], [27]. This well-established prevention program promotes resilience and prevents depression. Our team adapted the intervention to include diabetes-specific content. The focus of the intervention is on preventing depression through a resilience promoting curriculum, which offers the potential to fundamentally change participants' risk for depression and set adolescents on a trajectory toward improved adherence and health outcomes [34], [35]. Our research team adapted and pilot tested the PRP for adolescents with T1D (PRP T1D) [36] and then integrated the feedback, re-wrote the intervention, and pursued a randomized, controlled clinical trial. The goal of the Supporting Teen Problem Solving (STePS) randomized clinical trial was to test the efficacy of the intervention and to compare the effects of PRP T1D vs an advanced diabetes educational intervention (EI) on resilience characteristics, depressive symptoms, adherence behaviors, and glycemic outcomes. An advanced diabetes educational intervention was selected as the comparison group for two reasons: 1) to be consistent with a comparative effectiveness model for testing interventions and 2) to match for attention and time in intervention, versus standard care for diabetes. The present paper describes the study design, the intervention, and the baseline characteristics of the sample.