Reducing Distress and Improving Self-Care in Diabetes

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

• Diabetes Type 2

Interventions

BEHAVIORAL

Lifestyle and Activities Education Program (LEAP-AHEAD)

Patients in the LEAP-AHEAD Program arm will be shown a 40-minute interactional DVD and given the Healthy Habits Health Risk Appraisal, at baseline and 20 weeks that asks questions about diabetes self care practices and other health behaviors and gives recommendations in those areas. A score sheet based on the participant's responses will be left with the participant. At intervals from 0 to 44 weeks, patients will receive emailed informational pamphlets on diabetes and its complications, along with live telephone calls to answer any questions and check-in.

BEHAVIORAL

Computer Automated Self-Management (CASM)

CASM is a live and computer-assisted, low intensity, automated web and telephony based program that is directed at enhancing and sustaining diabetes self-management behavior over time. It provides education on the importance of healthy eating, physical activity and medication taking, and then asks patients to select an area for behavior change. At baseline patients will have a 45 minutes home visit to help them set goals and familiarize them with the website. A booster session is given at 20 weeks. Patients receive 8 ive phone calls over 12 months to support behavior change efforts.

BEHAVIORAL

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

Patients in the CAPS program receive all of the protocol included in the CASM program, and in addition receive a Problem Solving program. Problem solving is a process by which an individual attempts an adaptive solution to stressful, real life problem(s). At baseline there is a 45 minute home visit where the Counselor will introduce the patient to CASM and will go on to teach the patient about diabetes distress and PST. They will then generate a list of distress-related problems to teach the steps of PST. The steps of PST are: problem definition, goal setting, brain storming, decision making, action planning, and solution review. At 20 weeks there will be a booster session. Patients receive 8 live phone calls over 12 months to support behavior change efforts.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Lawrence Fisher, Ph.D. · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2011-11-30

Completion

2011-11-30

Countries

• United States

Study Locations