Diabetes Type 2 Clinical Trial
Official title:
Reducing Distress and Improving Self-Care in Diabetes
To date, there have been few practical, evidenced based interventions that are directed at
patients with Type II Diabetes who are experiencing depressed and/or emotional distress in
primary care settings. This study will (1) combine two existing, evidenced-based,
interventions (a computer automated, diabetes specific self-management program (CASM) vs. a
self-care program plus a live problem solving distress-reduction program (CAPS) vs. a
lifestyle and activities education program (LEAP-AHEAD)) into a practical, 3-arm clinical
trial with a highly distressed multi-ethnic patient sample, and (2) evaluate the
intervention using the RE-AIM framework, sharing the results through a comprehensive
dissemination package.
Hypothesis 1: The combined CASM and CAPS arms will be superior to the LEAP-AHEAD group on
the primary outcomes at follow-up.
Hypothesis 2: The CAPS arm will be superior to the CASM arm on primary outcomes at
follow-up.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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