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Reducing Distress and Improving Self-Care in Diabetes
NCT00714441 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Lifestyle and Activities Education Program (LEAP-AHEAD)
- BEHAVIORAL Computer Automated Self-Management (CASM)
- BEHAVIORAL Computer Automated Self-Management and Problem Solving Therapy (CAPS)
Study Locations (1)
California
- UC San Francisco, Family and Community Medicine Dept. — San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 392 participants |
| Start Date | 2008-07 |
| Est. Completion | 2011-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00714441
The ClinicalTrials.gov registry entry for NCT00714441 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 392 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francis, which has 1,574 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetes Type 2 appearing as the primary indexed condition, and to 3 interventions — of which Lifestyle and Activities Education Program (LEAP-AHEAD) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00714441 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00714441 about?
NCT00714441 is a clinical study titled "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,...
What is the current status of trial NCT00714441?
This trial is currently completed. It is a NA study. The enrollment target is 392 participants. The study started on 2008-07. Estimated completion is 2011-11.
What conditions does trial NCT00714441 study?
This clinical trial studies the following conditions: Diabetes Type 2. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00714441?
The interventions under investigation include: Lifestyle and Activities Education Program (LEAP-AHEAD) (BEHAVIORAL), Computer Automated Self-Management (CASM) (BEHAVIORAL), Computer Automated Self-Management and Problem Solving Therapy (CAPS) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00714441?
This trial is sponsored by University of California, San Francis, which has 1,574 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00714441 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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