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Scientific Rationale for Program ACTIVE II

Program ACTIVE II is a randomized controlled trial that will test the implementation of the program in Indianapolis and an expanded Appalachian region and test the comparative effectiveness of an interdisciplinary combination behavioral treatment of MDD (CBT+EXER) against exercise (EXER), CBT and usual care (UC) in treating T2DM and MDD outcomes.

Our group conducted a successful pilot study (R34DK071545) of the proposed intervention entitled, Program ACTIVE (Appalachians Coming Together to Increase Vital Exercise), to test the feasibility of recruitment, retention and ability to detect change in outcomes using CBT and community-based exercise to the treatment of MDD among rural adults with T2DM. In this single-arm pilot study, the combination approach resulted in improvements in diabetes, depression and LDL cholesterol outcomes at post-treatment and 3-month follow-up (3-Month) compared to baseline. Click here for Results from the Program ACTIVE Pilot Study.

The next logical step is to evaluate the comparative treatment and cost-effectiveness of the combination approach against individual treatment (i.e. CBT alone, exercise alone) and usual care (UC) in the context of standard T2DM care and nutrition education best practices to determine which strategies are the most suitable for adoption by rural communities throughout the U.S.

Studies examining the efficacy of exercise treatment for patients with major depression without diabetes have demonstrated beneficial effects for the treatment of current depressive episodes and prolonged remission of depressive episodes 6 months following treatment completion [15, 16]. No prior studies have combined CBT treatment with exercise in patients with T2DM. The combination of these treatment approaches has the potential to not only reduce depression but to improve diabetes outcomes and decrease cardiovascular risk factors.

Study Aims

Program ACTIVE II is a randomized controlled trial that will test the implementation of the program in Indianapolis and an expanded Appalachian region and test the comparative effectiveness of an interdisciplinary combination behavioral treatment of MDD (CBT+EXER) against exercise (EXER), CBT and usual care (UC) in treating T2DM and MDD outcomes.

Two primary aims will be addressed by Program ACTIVE II:
  1. To compare changes in glycemic control (as measured by HbA1c and fasting glucose) across intervention groups (CBT, EXER, CBT+EXER) to usual care (UC) following intervention (POST) and 6- and 12-month follow-up assessments.
  2. To compare changes in depression outcomes across intervention groups to usual UC at POST and 6- and 12-month follow-up assessments.
Two secondary aims will also be addressed by the study:
  1. To compare changes in cardiovascular risk factors, exercise capacity, blood lipid profiles, resting blood pressure across intervention groups to UC at POST, 6- and 12-month follow-up assessments.
  2. To assess comparative cost-effectiveness of each intervention arm against UC measured in terms of predicted incidence of diabetes complications (e.g. coronary heart disease) and quality of life years (QALYs).

Participants will be randomized to one of the four arms: CBT (10 individual sessions), EXER (12 weeks of community-based exercise), CBT+EXER (10 individual CBT session and 12 weeks of concurrent exercise) or UC. All participants will receive a diabetes education nutrition intervention entitled Dining with Diabetes. Participants will be assessed at baseline, POST, 6- and 12-month follow-up time points. Intervention materials developed in the previous pilot study will be used. A sample size of N=216 will be recruited.

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
  • Lifetime history of DKA
  • Lifetime history of Bipolar disorder, psychotic disorders or suicide attempt

What was the Program ACTIVE Intervention?

Participants in Program ACTIVE II will be randomized to one of 4 treatment arms: Usual Care, Cognitive Behavioral therapy alone, exercise alone or CBT+Exercise.

Participants randomized to the combination arm will receive 12-weeks of community-based exercise and 10-sessions of cognitive behavioral therapy. Both interventions are designed to behaviorally activate participants and provided them with problem-solving tools to better manage depression and diabetes symptoms.

In the exercise component, participants will be provided with 6 exercise training classes conducted trained participating fitness instructors. 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 will be provided.

Participants will also be provided with pedometers and glucometers to monitor steps and glucose values pre- and post-exercise. Participants will be given goals to engage in physical activity at the level of 150 minutes per week. Participants are given a supplemental workbook on the behavioral and motivational aspects of creating and maintaining an exercise routine and basic information about managing diabetes.

Participants in the CBT intervention will meet with a designated community therapist 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 will receive a CBT treatment workbook and prepare take-home exercises each week on these topics.

In addition, participants are provided with online "toolbox" materials that are designed to encourage participants to engage in routine physical activities.

All participants, including those assigned to the Usual Care condition, will receive free Dining with Diabetes classes, an educational program designed to teach participants healthy cooking and eating strategies for diabetes.

How Much Does the Program Cost?

Program ACTIVE is provided at no cost for people who qualify and join the study. Participants receive the following:

  • Fitness test
  • Pedometer to measure the number of steps each day
  • Glucometer and test strips to measure blood sugars
  • Access to the area exercise facilities at no cost
  • Dining with Diabetes classes

Participants may also receive at no cost:

  • 10 sessions of talk therapy
  • Passes to a local area community fitness center
  • 6 exercise classes

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 II

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. The information we collect as part of this study will help us to inform community partners and community leaders about the costs and benefits associated with Program ACTIVE so that it may continue to serve members of Appalachian communities in the future.

Materials Available for Physicians

Program ACTIVE is designed with busy physician practices in mind. We provide colleagues with:

Yes, I would like to be a referral source for Program ACTIVE II. (click here for local contact information for the Program ACTIVE study site near you.)