Reducing Distress and Improving Self-Care in Diabetes (REDEEM)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Diabetes Type 2

Treatments: Behavioral: Computer Automated Self-Management (CASM); Behavioral: Computer Automated Self-Management and Problem Solving Therapy (CAPS); Behavioral: Lifestyle and Activities Education Program (LEAP-AHEAD)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00714441

2R01DK061937-05A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 392 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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392 participants in 3 patient groups

2

Active Comparator group

Description:

Computer Automated Self-Management (CASM). Please see description below for CASM.

Treatment:

Behavioral: Computer Automated Self-Management (CASM)

3

Active Comparator group

Description:

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).

Treatment:

Behavioral: Computer Automated Self-Management and Problem Solving Therapy (CAPS)

Behavioral: Computer Automated Self-Management (CASM)

1

Active Comparator group

Description:

Lifestyle and Activities Education Program (LEAP-AHEAD). Please see description below for LEAP-AHEAD.

Treatment:

Behavioral: Lifestyle and Activities Education Program (LEAP-AHEAD)