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 was the Program ACTIVE Intervention?

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

In the exercise component, participants were provided with 6 exercise training classes conducted by Michael Kushnick, Ph.D., an exercise physiologist. Participants received 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 was provided.

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

Participants in the CBT intervention met with student therapists 10 times over the 12-week intervention period. Therapists used 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 received a CBT treatment manual and prepare take-home activities each week on these topics.

In addition, participants were provided “toolbox” materials that were 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

Program ACTIVE Results

Patients (Ps) with type 2 diabetes (T2DM) are twice as likely to experience depression (MDD) as non-T2DM peers. In this population, MDD contributes to decreased self-efficacy (SE) and diabetes quality of life (DQOL), negatively impacts social support and resources for chronic-illness management (CIRS), and reduces self-care behaviors (e.g., exercise).

Program ACTIVE was a single-arm repeated measures trial designed to test the effectiveness of a novel combination of community-based exercise (12 wks) and cognitive behavioral therapy (CBT; 10 sessions) treatment on MDD in rural T2DM Appalachians. This study asked if improvements could be seen in depressive symptoms (BDI), SE, DQOL, CIRS, exercise-related stage of change (SOC), and exercise in this rigorous intervention. Outcome variables were measured at baseline, post-intervention (POST) and 3-month follow-up (3MFU).

Ps (N=50) were 68% female, 74% married, and had a mean age of 57 (S.D. 9). The modal income was $21-40,000/yr. Mean duration of T2DM was 11 yrs (S.D. 7) and mean BMI was 35.1 (S.D. 7.1).

Using intent-to-treat analyses, mean BDI scores improved at POST (p<.01) and 3MFU (p<.01). Mean BDI scores dropped from moderate/severe to mild levels at POST (M=16.7, S.D. 13) and 3MFU (M=17.5, S.D. 12.1). DQOL and CIRS improved at POST (M=5.9, S.D. 8.8, p<.01; M=7.9, S.D. 12, p<.01 respectively) and 3MFU (M=5.5, S.D. 7.7, p<.01; M=2.1, S.D. 11.4 respectively).

Evaluation of exercise SOC showed that Ps moved from the preparation to action stage at POST. Ps completed 193 min/wk of aerobic activity (range: 76-478) during the intervention exceeding the 150 min/wk goal. Self-reported exercise improved significantly at POST (11.9, S.D. 18.5, p<.01) and 3MFU (10.2, S.D. 16.6, p<.01). Ps reported increased SE from baseline to POST (M=5.9, S.D. 13.6, p<.05).

This study demonstrated that significant improvements can be gained in quality of life, social support, and exercise-related self-efficacy in a rigorous combination treatment approach for depression among Appalachians with T2DM.

How Much Does the Program Cost?

Program ACTIVE was FREE for people who qualify and join the study. Participants received 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

Were There Any Risks to Participants Who Joined Program ACTIVE?

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

Long-Term Goals of Program ACTIVE

Program ACTIVE was 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 was designed with busy physician practices in mind. We provided 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

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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.
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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.
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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: June 1, 2009