A process evaluation of a pragmatic randomized controlled trial to promote mental health among adults with Type 1 diabetes

PROJECT SUMMARY/ABSTRACT People with type 1 diabetes (T1D) have an increased risk of developing depression, yet rarely receive treatment for depression and diabetes simultaneously. The absence of treatment is linked to a reduced chance of achieving target glycemic goals, thereby raising the risk of complications such as diabetic retinopathy and neuropathy. Integrated care models, such as the Collaborative Care Model (CoCM), have been developed to treat health and mental health needs. However, CoCMs have not been adapted and analyzed for patients with T1D and depression. To bridge this knowledge gap, Mr. Cooper will conduct a secondary analysis of change mechanisms within a CoCM adapted for patients with T1D and depression in a diabetes specialty clinic from data included in the parent RCT. Additionally, Mr. Cooper will analyze implementation outcomes including acceptability, fidelity, and the potential scalability of the CoCM for primary care settings. The specific aims are to (1) analyze change mechanisms in the adapted CoCM for T1D and depression outcomes. Participants enrolled in the parent study (n=80) will complete validated measures of, self-efficacy, motivation, and diabetes self-management at three time points (0-,6-, and 12- months) to measure hypothesized change mechanisms concerning the primary outcomes [depression (Patient Health Questionnaire) and glycemic control (HbA1c)]. (2) Evaluate implementation outcomes (acceptability, fidelity, and scalability) of the adapted CoCM. Acceptability will be captured through validated surveys and in-depth interviews with participants and clinic actors. Fidelity will be analyzed through structured observations and checklists. Scalability will be analyzed through surveys with primary care staff. Achieving the aims of this study will produce knowledge regarding how the active ingredients of an adapted CoCM relate to treatment outcomes for those with T1D and depression. Also, the study will provide information regarding implementation factors needed to promote uptake and sustainability for the CoCM. In addition, this work will support the training of Mr. Cooper who is devoted to a career in researching behavioral interventions to address multimorbid conditions. Mr. Cooper’s 2-year training plan includes (1) Advanced training in randomized clinical trials (RCTs), (2) developing methodological skills in implementation science, (3) training in advanced statistical modeling to evaluate change mechanisms longitudinally, and (4) advanced study on the psychological, behavioral, and biological mechanisms of T1D and depression. The team of mentors, Drs. Mowbray (Sponsor), Ali (Co-Sponsor), and Johnson (Co-Sponsor) will lend their expertise to mentor Mr. Cooper on these training goals. Mr. Cooper will leverage connections with the University of Georgia, Emory University, the Georgia Clinical and Translational Science Association, the Emory Global Diabetes Research Center, the Georgia Translational Diabetes Research Center, and the Network for Evaluation and Implementation Sciences at Emory. The candidate, the mentorship team, and the environment are uniquely suited to effectively achieve the proposed research and training aims.