Reducing Distress and Improving Self-Care in Diabetes

Completed · Not applicable

Conditions studied: Diabetes Type 2

In brief

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.

Key facts

Study ID

NCT00714441

Run by

University of California, San Francisco

People needed

392

Starts

2008-07-01

Expected to finish

2011-11-01

Last updated by the study team

2012-04-19

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of type 2 diabetes (confirmed using the Wellborn criteria for a minimum of 12 months)
• Be between 21 and 75 years of age
• Speak and read Spanish or English fluently
• In addition, based on the telephone screening, patients will have to display a high level of diabetes distress and a deficit in at least one of three self-management areas (diet, physical activity, medication adherence). This is defined as having an average item score > 3.0 on 2 items from the regimen distress and emotional burden sub scale of the DDS and indication of problems in management on at least one scale of the SDSCA (i.e., endorsing having a healthy eating plan on less than 5 days/week, 30 minutes physical activity less than 5 days/week, or forget to take medicines more than 1 day/week).
• Have access to the internet

You may not qualify if…

• Have major disabilities or severe disorders (MI in the last 12 months, psychosis, on end-stage dialysis, dementia)
• Have current MDD (based on the PHQ8).

Where it is running

• UC San Francisco, Family and Community Medicine Dept. — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.