Reducing Distress and Improving Self-Care in Diabetes

Not Applicable

Completed

• Conditions: Diabetes Type 2
• Interventions: Behavioral: Computer Automated Self-Management (CASM); Behavioral: Lifestyle and Activities Education Program (LEAP-AHEAD); Behavioral: Computer Automated Self-Management and Problem Solving Therapy (CAPS)

• Registration Number: NCT00714441
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-09
• Study First Submitted QC: 2008-07-09
• Study First Posted: 2008-07-14
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-17
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Computer Automated Self-Management (CASM)	Computer Automated Self-Management (CASM). Please see description below for CASM.
3	Computer Automated Self-Management (CASM)	Computer Automated Self-Management and Problem Solving Therapy (CAPS). Please see descriptions below for CAPS (also refer to CASM with is included in the CAPS program).
3	Computer Automated Self-Management and Problem Solving Therapy (CAPS)	Computer Automated Self-Management and Problem Solving Therapy (CAPS). Please see descriptions below for CAPS (also refer to CASM with is included in the CAPS program).
1	Lifestyle and Activities Education Program (LEAP-AHEAD)	Lifestyle and Activities Education Program (LEAP-AHEAD). Please see description below for LEAP-AHEAD.

Primary Outcome Measures

Name	Time	Method
Diet. Starting the Conversation is a 9 items measure of eating patterns (including 2 items from the NCI Fruit and Vegetable Screener). NCI Percent Energy from Fat Screen (PFAT) contains 17 items concerning frequency of intake for 15 food groups.	Baseline, 16 weeks, and 12 months
Physical Activity. The CHAMPS (28 items) will be used to measure physical activity.	Baseline, 16 weeks, and 12 months
Medication Adherence. Medication taking will be assessed by the Hill-Bone Medication Adherence scale. Questions will also cover smoking and alcohol use.	Baseline, 16 weeks, and 12 months
Distress. Patient distress will be assessed across several measures including: the 20-item CES-D, the 17-item DDS, the PHQ8, and screening items from the SCID to rule out psychosis.	Baseline, 16 weeks, and 12 months

Secondary Outcome Measures

Name	Time	Method
HbA1C	Baseline, 16 weeks, and 12 months
Blood Pressure	Baseline, 16 weeks, and 12 months
Fasting glucose	Baseline, 16 weeks, and 12 months
Lipids	Baseline, 16 weeks, and 12 months

Trial Locations

Locations (1)

UC San Francisco, Family and Community Medicine Dept.; 🇺🇸 San Francisco, California, United States