Abstract
BackgroundDiabetes distress (DD), a type of psychological distress specific to people with diabetes, is strongly associated with difficulties in performing self-care and inability to meet glycemic targets. Despite increased recognition of the need to manage DD, interventions that are both feasible and effective for reducing DD in routine care settings are not yet known. A pilot study showed that health coaching (HC) has some efficacy in addressing DD, but no adequately powered study has implemented a pragmatic research design capable of assessing the real-world effectiveness of HC in reducing DD.ObjectiveThe aim of this study is to describe the rationale and design of an ongoing clinical trial, Coaching and Education for Diabetes Distress trial, that seeks to assess whether HC effectively reduces DD among primary care patients with diabetes and whether HC is more effective than an educational program targeting DD.MethodsThe 2-arm randomized controlled trial is taking place at an academic family medicine practice in Houston, Texas. Both arms will receive usual care, which includes education about DD. In addition, the intervention arm will receive 8 HC sessions over a 5-month period. The primary outcome measure is reduction in DD over a 6-month period. Additional outcome measures include changes in hemoglobin A1c and self-care practices (medication-taking, dietary, and physical activity behaviors).ResultsAs of March 2019, screening and recruitment are ongoing, and the results are expected by July 2020.ConclusionsHC is feasible in primary care and has been successfully applied to improving chronic disease self-management and outcomes. This study will provide evidence as to whether it has significant value in addressing important unmet psychological and behavioral needs of patients with diabetes.Trial RegistrationClinicalTrials.gov NCT03617146; https://clinicaltrials.gov/ct2/show/NCT03617146 (Archived by WebCite at http://www.webcitation.org/76Va37dbO)International Registered Report Identifier (IRRID)DERR1-10.2196/12166
Highlights
Diabetes distress (DD) is a negative emotional reaction to diagnosis of diabetes and concerns about treatment demands, risk of complications, and inadequate support [1]
DD is most strongly associated with difficulties in performing self-care and inability to meet glycemic targets [2,3,4], and it is more common than major depressive disorder (MDD) [5], leading to calls for DD management to become an essential component of diabetes care [1,6]
Psychoeducational approaches were the only approaches found to significantly reduce DD compared with controls
Summary
Diabetes distress (DD) is a negative emotional reaction to diagnosis of diabetes and concerns about treatment demands, risk of complications, and inadequate support [1]. DD, along with major depressive disorder (MDD) and other depressive symptomatology, constitutes significant emotional and psychological burden to people with diabetes [1,2] Among these distinct conditions, DD is most strongly associated with difficulties in performing self-care and inability to meet glycemic targets [2,3,4], and it is more common than MDD [5], leading to calls for DD management to become an essential component of diabetes care [1,6]. Methods: The 2-arm randomized controlled trial is taking place at an academic family medicine practice in Houston, Texas Both arms will receive usual care, which includes education about DD. Trial Registration: ClinicalTrials.gov NCT03617146; https://clinicaltrials.gov/ct2/show/NCT03617146 (Archived by WebCite at http://www.webcitation.org/76Va37dbO) International Registered Report Identifier (IRRID): DERR1-10.2196/12166
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