Expired Study
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San Francisco, California 94143


Purpose:

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.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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).


NCT ID:

NCT00714441


Primary Contact:

Principal Investigator
Lawrence Fisher, Ph.D.
University of California, San Francisco


Backup Contact:

N/A


Location Contact:

San Francisco, California 94143
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 17, 2018

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