Diabetes Mellitus, Type 2 Clinical Trial
Official title:
University of California, Los Angeles (UCLA)/Drew Project EXPORT: Mood and Diabetes Empowerment & Improvement Training (MADE IT)
In this project, investigators examine the impact of a mood treatment enhanced diabetes self-care intervention for depressed, low-income Latino diabetics. The investigators hypothesize that the mood treatment enhancement will lead to significant improvement in both diabetes and depression outcomes as compared with the self-care intervention alone.
The Phase I pilot recruited older Latinos from Dr. Mangione's previous study (who agreed to
participate in future research) and 10 participants from a community settings. Those with
low mood and poor glycemic control were offered a 12-week intervention combining cognitive
behavioral therapy mood management techniques and diabetes self-care into one seamless
intervention. Drs. Mangione and Miranda supervised and reviewed (through audiotapes)
well-trained health educators conducting the intervention sessions. The study manuals were
modified following this Phase I pilot intervention.
The final intervention manual was tested in a randomized trial in Phase II, compared the
Mood and Diabetes Empowerment and Improvement Training intervention with enhanced care as
usual (providing participants with a letter regarding their mood and hemoglobin (Hb)A1c with
recommendations for improving care for their provider). The target population was low-income
Latinos with depression and poor glycemic control. Both mood and diabetes outcomes are
evaluated.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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