Objective:

To compare the effectiveness of usual care (UC) versus a culturally tailored integrated care model in improving mental health symptoms for Latino patients with Type 2 diabetes mellitus (T2DM).

Methods:

We conducted a two-arm randomized controlled trial from 2015 to 2019 at a federally qualified health center. Participants were 456 adults ages 23-80 years who had a previous diagnosis of T2DM and were not currently using insulin. Participants were randomly assigned to Integrated Care Intervention (ICI; including behavioral/mental healthcare, medical visits, health education and care coordination) or UC; standard of care including referrals for health education and behavioral/mental health care where appropriate. Intention-to-treat, multilevel models were used to compare group × time changes in depression and anxiety symptoms (PHQ-8; GAD-7) and perceived stress (PSS-10) across 6 months.

Results:

Participant mean age was 55.7 years, 36.3% were male, and 63.7% were primarily Spanish speaking. Baseline sociodemographic factors and mental health symptoms across study arms were balanced. Significant group × time interaction effects were observed for anxiety and depression symptoms (p < .05). Within the ICI and UC groups, mean depression symptom changes were -0.93 and -0.39 (p < .01); anxiety symptom changes were -0.97 (p < .01) and -0.11 (p = .35); and perceived stress changes were -1.56 and -1.27 (p < .01), respectively.

Conclusions:

Although both ICI and UC showed decreases over time, the ICI group evidenced larger, statistically significant changes in both depression and anxiety. Adapted integrated models of behavioral and chronic disease management appear to be effective and could be considered for usual care practices.

Clinicaltrials.gov identifier:

NCT03983499.