Study Aims

1. To assess the feasibility of recruitment and retention of type 2 diabetes patients in the community to the study protocol;
    
2. To assess improvements in depression from baseline to follow-up assessment (post-intervention and 3-month follow-up);
    
3. To assess improvements in diabetes outcomes (HbA1c) from baseline to follow-up assessment;
    
4. To assess improvements in cardiovascular risk factors from baseline to follow-up.

Inclusion Criteria

• Patients with type 2 diabetes with 1 year duration or longer
• Current depressive episode (resulting in clinical impairment)
• Individuals for whom routine exercise is appropriate and recommended
• Medically stable individuals

Exclusion Criteria

• Lifetime history of stroke
• History of MI, stent placement, CABG or aortic stenosis in the past year.
• History of laser treatment for proliferative retinopathy in the past 6 months
• Lower extremity amputation
• Uncontrolled stage II hypertension

What is the Program ACTIVE Intervention?

Participants in Program ACTIVE engage in two primary forms of intervention: 12-weeks of community-based exercise and 10-sessions of cognitive behavioral therapy. Both interventions are designed to behaviorally activate participants and provide them with problem-solving tools to better manage depression and diabetes symptoms.

In the exercise component, participants are provided with 6 exercise training classes conducted by Michael Kushnick, Ph.D., an exercise physiologist. Participants receive training to monitor heart rate, blood glucose and make adjustments to their exercise regimen during each session. Safety guidelines for exercise (e.g. correct procedures for warm-up and cool-down periods) as well as orientation to various exercise equipment is provided.

Participants are also provided with pedometers and glucometers to monitor steps and glucose values pre- and post-exercise. Participants are given goals to engage in physical activity up to 150 minutes per week. Participants are given a supplemental manual on the behavioral and motivational aspects of creating and maintaining an exercise routine.

Participants in the CBT intervention meet with student therapists 10 times over the 12-week intervention period. Therapists use standard CBT tools to set treatment goals, identify and problem-solve problem behaviors, identify cognitive distortions and negative automatic thoughts and explore depressogenic core beliefs. Participants receive a CBT treatment manual and prepare take-home activities each week on these topics.

In addition, participants are provided “toolbox” materials that are designed to encourage participants to engage in routine physical activities.

See some examples of our intervention materials…

• CBT Manual: Introduction and Chapter 1
• Exercise Manual: Introduction and Chapter 1
• Handouts: Keeping It Safe and Step Your Way to Success
• Appalachian Trail and Program ACTIVE hiker
• Activity Log
• Buckeye Trail Map

How Much Does the Program Cost?

Program ACTIVE is FREE for people who qualify and join the study. Participants receive the following:

• Cardiac stress test
• Pedometer to measure the number of steps you walk each day
• Glucometer and test strips to measure your blood sugars
• Access to the area exercise facilities
• Medical Exam
• 10 sessions of talk therapy

Are There Any Risks to Participants Who Join Program ACTIVE?

Study investigators take special precautions to minimize risks to participants. Minor risk is associated with the collection of blood samples which are requested over the course of the study. There is also minor risk of discomfort for some who attend talk therapy sessions.

Long-Term Goals of Program ACTIVE

Program ACTIVE is designed to serve as a pilot and feasibility study that will inform the creation of a large-scale study to be submitted for funding from NIDDK. Infrastructure created in this current study as well as scientific findings will be used in the design of the larger project. The long-term goal of Program ACTIVE is to create a self-sufficient diabetes and depression treatment program in the community beyond the period of federal funding.

Materials Available for Physicians

Program ACTIVE has been designed with busy physician practices in mind. We are happy to provide colleagues with:

• Exam room posters (click here for an example)
• Waiting room flyers (click here for an example)
• Letter templates to announce the study to eligible patients (click here for an example)

References

1. Wild, S., Roglic, G., Green, A., Sicree, R, King, H., Global prevalence of diabetes. Estimates for the year 2000 and projectiions for 2030. Diabetes Care, 2004. 27(5): p. 1047-53.
2. (ILGARD), I.o.L.G.A.a.R.D., Appalachian Rural Health Institute Health Needs Assessment Survey Report of Findings. 2004, Ohio University's Voinovich Center for Leadership and Public Affairs: Athens, OH.
3. ADA, A.D.A., Diabetes 2001 Vital Statistics. 2001, Alexandria, VA: American Diabetes Association.
4. Weng, C., D.V. Coppini, and P.H. Sonksen, Geographic and social factors are related to increased morbidity and mortality rates in diabetic patients. Diabet Med, 2000. 17(8): p. 612-617.
5. Anderson, R.J., et al., The prevalence of comorbid depression in adults with diabetes: a meta-analysis. Diabetes Care, 2001. 24(6): p. 1069-78.
6. Lustman, P.J., et al., Depression and poor glycemic control: a meta-analytic review of the literature. Diabetes Care, 2000. 23(7): p. 934-42.
7. de Groot, M., et al., Association of depression and diabetes complications: a meta-analysis. Psychosom Med, 2001. 63(4): p. 619-30.
8. Egede, L.E., Zheng, D., & Simpson, K., Comorbid depression is associated with increased health care use and expenditures in individuals with diabetes. Diabetes Care, 2002. 25(3): p. 464-470.
9. Ciechanowski, P.S., Katon, W. J., & Russo, J. E., Depression and diabetes: Impact of depressive symptoms on adherence, function, and costs. Arch Intern Med, 2000. 160: p. 3278-3285.
10. Goldney, R.D., Phillips, P.J., Fisher, l.J., Wilson, D.H., Diabetes, depression and quality of life. A population study. Diabetes Care, 2004. 27(5): p. 1066-70.
11. Lustman, P.J., et al., Cognitive behavior therapy for depression in type 2 diabetes mellitus. A randomized, controlled trial. Ann Intern Med, 1998. 129(8): p. 613-21.
12. Lustman, P.J., et al., Effects of nortriptyline on depression and glycemic control in diabetes: results of a double-blind, placebo-controlled trial. Psychosom Med, 1997. 59(3): p. 241-50.
13. Lustman, P.J., et al., Fluoxetine for depression in diabetes: a randomized double-blind placebo-controlled trial. Diabetes Care, 2000. 23(5): p. 618-23.
14. Goodnick, P.J., Kumar, A., Henry, J. H., Buki, V. M., & Goldberg, R. B., Sertraline in coexisting major depression and diabetes mellitus. Psychopharmacol Bull, 1997. 33(2): p. 261-264.
15. Blumenthal, J.A., Babyak, M.A., Moore, K.A., Craighead, E., Herman, S., Khatri, P., Waugh, R., Napolitano, M.A., Forman, L.M., Appelbaum, M., Doraiswamy, M., Krishnan, R., Effects of exercise training on older patients with major depression. Arch Intern Med, 1999. 159: p. 2349-2356.
16. Babyak, M., Blumenthal, J. A., Herman, S., Khatri, P., Doraiswamy, M., Moore, K., Craighead, E., Baldewicz, T. T., & Krishnan, R., Exercise treatment for major depression: Maintenance of therapeutic benefit at 10 months. Psychosom Med, 2000. 62: p. 633-638.

Updated: November 9, 2007